xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017934</url>
    </required_header>
    <id_info>
      <org_study_id>ERGO 84163</org_study_id>
      <nct_id>NCT06017934</nct_id>
    </id_info>
    <brief_title>Promoting Increased Physical Activity in Hospitalised Older Adults</brief_title>
    <acronym>PIVOT</acronym>
    <official_title>PIVOT Trial: Promoting Increased Physical Activity in Hospitalised Older Adults With Trained Volunteers: An Implementation Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Southampton</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute for Health Research, United Kingdom</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Leeds</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Portsmouth Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Salisbury NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Newcastle-upon-Tyne Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Frimley Park Hospital NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Southampton</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The PIVOT study will explore the feasibility of training volunteers to deliver exercise to&#xD;
        hospitalised older adults to improve the health of older people and prevent deconditioning&#xD;
        while in hospital. Loss of strength and mobility (i.e., deconditioning) is common in&#xD;
        hospitalised older people and is associated with a decline in physical function, poorer&#xD;
        quality of life and increased health and care costs. Physical inactivity is an important and&#xD;
        modifiable risk factor. A previous study showed it is feasible to train volunteers to engage&#xD;
        with older people in hospital and facilitate walking and bedside exercises. The intervention&#xD;
        was well-received by older adults, staff members and volunteers. The aim of this study is to&#xD;
        determine the feasibility of implementing volunteer-led physical activity in three hospitals&#xD;
        of varying sizes in different regions.&#xD;
  &#xD;
        Older adults aged 65 years and above admitted to an acute hospital will be invited to&#xD;
        participate in the study. The study aims to recruit 180 participants; 90 from three&#xD;
        intervention sites and 90 from a control site. Participants at the intervention sites will&#xD;
        receive a twice daily volunteer-led physical activity intervention, and participants at the&#xD;
        control site will receive usual care.&#xD;
  &#xD;
        Participants who are able to mobilise independently will perform walking exercises and&#xD;
        individuals with mobility impairments will perform bedside exercises. The volunteers will be&#xD;
        trained and monitored by hospital therapists. The acceptability of the intervention will be&#xD;
        explored through interviews with patients, volunteers, and staff. Intervention feasibility&#xD;
        will also be examined through measuring retention of trainers, volunteers, and patients on&#xD;
        the intervention, and adherence to the exercise.&#xD;
  &#xD;
        Study findings will help to determine the feasibility of the volunteer-led physical activity&#xD;
        intervention across different sized hospitals, voluntary service teams, and therapy services&#xD;
        to explore the implementation and roll out of the intervention across NHS sites and the&#xD;
        development of a toolkit to support knowledge transfer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim The aim of the current research is to explore whether volunteers can be trained to&#xD;
        deliver exercise support to older adults across three different sized hospitals in different&#xD;
        locations. Researchers will also explore if the intervention is accepted by patients,&#xD;
        volunteers and staff and if it has any benefits on patients' health and functional outcomes&#xD;
        (e.g., quality of life and muscle strength).&#xD;
  &#xD;
        Study Design This is a multicentre feasibility study using mixed methods (i.e., quantitative&#xD;
        and qualitative measures) to explore the implementation of a volunteer-led physical activity&#xD;
        intervention to older adults in hospital. The study will include three intervention sites and&#xD;
        one control site. Feasibility studies are used to determine whether an intervention is&#xD;
        appropriate for further evaluation, to determine sample sizes for controlled trials and to&#xD;
        assess whether the ideas and findings can be shaped to be relevant and sustainable.&#xD;
  &#xD;
        Sample Size A sample size of 180 patients, 90 intervention (30 from each intervention site)&#xD;
        and 90 from the control site, was chosen in line with previous sample size recommendations&#xD;
        for feasibility studies of 24-50 participants. This sample size was considered an appropriate&#xD;
        number that is pragmatic and achievable within the study timescale and resources available at&#xD;
        each site.&#xD;
  &#xD;
        This research aims to recruit 15 volunteers at each site to provide sufficient cover to&#xD;
        deliver the intervention. In a previous study (SoMoVe trial) 17 volunteers were recruited, 16&#xD;
        completed training and 12 were retained.&#xD;
  &#xD;
        Recruitment and Consent Older adults with an acute medical admission to four hospitals will&#xD;
        be screened for eligibility by research nurses. Eligible patients will be introduced to the&#xD;
        study by ward staff. Those who are interested in the study will be approached by the research&#xD;
        team for further information and information sheets will be provided. Written informed&#xD;
        consent will be obtained from all patients who agree to participate in the study.&#xD;
  &#xD;
        Volunteers will be invited by hospital voluntary services within each hospital site. The&#xD;
        voluntary services team will send the interested volunteers details to the research team, who&#xD;
        will then get in contact to complete informed consent.&#xD;
  &#xD;
        Inclusion and Exclusion Criteria Patients: The inclusion criteria are adults aged 65 years&#xD;
        and above who are able to provide informed consent. Exclusion criteria are anyone with a&#xD;
        severe cognitive impairment (MoCA less than 10), patients isolated for infection control&#xD;
        reasons, and patients receiving end of life care.&#xD;
  &#xD;
        Volunteers: The inclusion criteria for volunteers are age 18 years and above, who have&#xD;
        completed the generic clearance and training with the hospital voluntary services, who can&#xD;
        provide written informed consent, and are able to communicate fluently enough in English.&#xD;
        Fluent English is required to ensure the intervention content can be delivered clearly and&#xD;
        thus safely to participants. Volunteers that are unable to safely complete the exercises&#xD;
        included in the intervention will be excluded from the study.&#xD;
  &#xD;
        Intervention The exercises were developed based on clinical expertise from therapists and&#xD;
        from our previous research of volunteer-led mobility interventions in hospital (SoMoVe&#xD;
        study). Participants will be assessed by the therapy team who will prescribe tailored&#xD;
        activity and then liaise with the mobility volunteers, who will deliver the intervention.&#xD;
        Participants who can mobilise independently will be encouraged to perform walking exercises,&#xD;
        progressing their walking distance over set markers in the hospital (e.g., to the end of the&#xD;
        bed and back; to the doorway and back; to the toilet and back). Participants who require&#xD;
        assistance in mobility will perform bed (e.g., hip abduction, static quads), or chair&#xD;
        exercises (e.g., ankle pumps, knee extension, arm raise), and will be progressed to&#xD;
        performing walking exercises when their physical function improves. Volunteers will check&#xD;
        with nursing staff that participants are safe to exercise before each activity session.&#xD;
        Participants will receive the mobility sessions twice daily, starting upon recruitment and&#xD;
        continuing until the day of discharge from hospital.&#xD;
  &#xD;
        Training The volunteer training package was developed by a clinician and therapist and will&#xD;
        cover topics including patient and personal safety, mobility and exercise training, and&#xD;
        response to adverse evets, such as falls. Volunteers will participate in practical sessions&#xD;
        to practice the exercises with peers. When ready, volunteers will work with patients,&#xD;
        initially under close supervision and when deemed competent by the trainer, they will be&#xD;
        encouraged to support mobility sessions independently. A volunteer competency checklist will&#xD;
        be completed and signed off by the trainer before volunteers work independently. The training&#xD;
        will be delivered by a physiotherapist in each intervention site.&#xD;
  &#xD;
        Fidelity Checks Throughout the study period, fidelity checks will be conducted by the&#xD;
        trainers once every 2 weeks to ensure that the volunteers are delivering high quality and&#xD;
        safe exercise. The volunteers will be observed and assessed against a competency and&#xD;
        implementation checklist, including personal safety, basic patient safety, pre-intervention&#xD;
        tasks (e.g., safe set up of exercise space), and exercise delivery (e.g., showing safe and&#xD;
        effective exercise technique). Volunteers will be asked to keep an attendance record during&#xD;
        the intervention using session completion logs. Regular monthly volunteer meetings will be&#xD;
        scheduled online to discuss experiences and gain feedback from peers and trainers. Based upon&#xD;
        fidelity checks and volunteer feedback, extra one-to-one training sessions will be available&#xD;
        if necessary. The principle investigator will also visit intervention sites to observe and&#xD;
        liaise with volunteers and trainers.&#xD;
  &#xD;
        Data Collection Data including age, sex, co-morbidities, medications, functional status, and&#xD;
        cognition will provide participants' baseline characteristics in both intervention and&#xD;
        control sites.&#xD;
  &#xD;
        Volunteer data including age, occupation, qualifications, volunteering experience, any&#xD;
        physiotherapy, sport or therapeutic experience, and employment status will be collected. Data&#xD;
        on the study sites including hospital size, size of voluntary service team, the number of&#xD;
        hospital volunteers, and information on the therapy services and what usual care looks like&#xD;
        will be collected to provide contextual information.&#xD;
  &#xD;
        The primary outcome measures are feasibility (can it be done?) and acceptability (will&#xD;
        volunteers, staff, and patients accept and embrace the programme?) of the intervention.&#xD;
  &#xD;
        Feasibility will be assessed by:&#xD;
  &#xD;
          1. Number of trainers trained and retained in each hospital site (total number and %)&#xD;
  &#xD;
          2. Number of volunteers recruited, trained, and retained (total number and %)&#xD;
  &#xD;
          3. Recruitment rate (%) of participants in each site&#xD;
  &#xD;
          4. Adherence to the intervention (total number and %)&#xD;
  &#xD;
        Acceptability will be assessed through process evaluation involving:&#xD;
  &#xD;
          1. Observation and monitoring of volunteer training&#xD;
  &#xD;
          2. Interviews with therapy managers to establish usual care in each site&#xD;
  &#xD;
          3. Observation of the interaction between volunteers, patients, and healthcare&#xD;
             professionals on the wards, including contextual factors that may potentially influence&#xD;
             the delivery and receipt of the intervention.&#xD;
  &#xD;
        Qualitative interviews will be conducted with service managers, therapy managers, patients,&#xD;
        nurses, ward therapists, and volunteers from all study sites, to determine the acceptability&#xD;
        of the intervention. Purposive sampling will be conducted to capture a range of experiences&#xD;
        and opinions from patients of varying age and mobility levels, staff with varying seniority&#xD;
        and gender mix, and volunteers with a range of volunteering experience, age groups, and&#xD;
        gender mix. The interviews will explore barriers and facilitators to the implementation of&#xD;
        the intervention into routine clinical practice.&#xD;
  &#xD;
        Fidelity Assessment Fidelity assessment will be conducted across all study sites to ensure&#xD;
        that the exercises and prescribed dose are delivered by the volunteers as prescribed.&#xD;
        Volunteers will be trained to document each physical activity session in participant exercise&#xD;
        diaries, detailing whether all the exercises were carried out as prescribed, or whether some&#xD;
        exercises were excluded, and reasons for exclusions. The exercise diaries will be affixed to&#xD;
        participants' activity prescription sheet. Further assessments of fidelity of volunteer&#xD;
        training and the intervention will be conducted through site visits by the research fellow&#xD;
        once every 2 months and to address any issues that arise.&#xD;
  &#xD;
        Secondary Outcome Measures The secondary outcome measures will include assessment of physical&#xD;
        activity levels (StepWatch Activity Monitor; SAM; Modus health, Washington, USA), physical&#xD;
        function (Short Physical Performance Battery and grip strength), and quality of life&#xD;
        (EuroQol; EQ-5D-5L). Moreover, data on length of hospital stay and hospital readmission will&#xD;
        be accessed through electronic patient records. Data collection will be conducted by research&#xD;
        nurses, supported by the local principal investigators.&#xD;
  &#xD;
        Data Analysis Primary Outcome Analyses Participants' baseline characteristics will be&#xD;
        described using summary statistics, including mean (standard deviations), medians&#xD;
        (interquartile ranges), counts and proportions, as appropriate. Statistical analysis will be&#xD;
        conducted using the statistical software SPSS. Summary statistics will be used to describe&#xD;
        the feasibility of recruiting, training, and retaining the trainers, the volunteers and study&#xD;
        participants. Participants' exercise diaries will be analysed to determine how many physical&#xD;
        activity sessions were offered and the number and percentage of completed sessions.&#xD;
  &#xD;
        Data collected from the interviews will be transcribed verbatim and analysed using thematic&#xD;
        analysis (TA). The audio- recordings will be transcribed by an administrative colleague&#xD;
        within the research department who is experienced in transcribing qualitative data. TA is a&#xD;
        method for identifying, analysing and reporting patterns or themes within data and is widely&#xD;
        used in qualitative research. Transcribed text will be read and coded separately and then&#xD;
        together by two researchers. The codes will be analysed to generate concepts and ideas to&#xD;
        determine the acceptability of the intervention, and to identify facilitators and barriers to&#xD;
        the implementation process. The codes act as tags or labels to help catalogue key concepts&#xD;
        embedded within the raw data. From the codes, themes will be developed to reflect the views&#xD;
        and experiences of the older adults and volunteers regarding the volunteer-led physical&#xD;
        activity intervention.&#xD;
  &#xD;
        Secondary Outcome Analyses Daily step count, Short Physical Performance Battery, grip&#xD;
        strength, and quality of life measured on recruitment and discharge, and length of hospital&#xD;
        stay will be analysed as continuous variables. The completion rate of each data item will be&#xD;
        measured. The distribution of each outcome measure will be assessed for normality and&#xD;
        described using parametric or non-parametric statistics accordingly. Hospital readmission in&#xD;
        3 and 6 months will be analysed as a categorical variable. Where there is missing data, the&#xD;
        main analyses will be based on available data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2026</completion_date>
    <primary_completion_date type="Anticipated">November 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Qualitative interview data exploring the acceptability of the intervention, including barriers and enablers to the implementation of the intervention.</measure>
      <time_frame>through intervention completion, an average of 2 months</time_frame>
      <description>Qualitative interviews will be conducted with service managers, therapy managers, patients, nurses, ward therapists, and volunteers from all study sites, to determine the acceptability of the intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The number of volunteers recruited to the study (%).</measure>
      <time_frame>through study completion, an average of 3 years</time_frame>
      <description>Feasibility of recruiting volunteers to deliver the physical activity intervention at each hospital site</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of trainers trained in each hospital site (%)</measure>
      <time_frame>through study completion, an average of 3 years</time_frame>
      <description>Feasibility of recruiting therapists to deliver the intervention at each hospital site.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to the intervention (%)</measure>
      <time_frame>through study completion, an average of 3 years</time_frame>
      <description>The number of participants retained in the intervention at each hospital site.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment rate (%) of participants in each site</measure>
      <time_frame>through study completion, an average of 3 years</time_frame>
      <description>Feasibility of recruiting older adults onto the volunteer-led physical activity intervention at each hospital site.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The number of volunteers trained at the end of the study period (%)</measure>
      <time_frame>through study completion, an average of 3 years</time_frame>
      <description>Feasibility of training volunteers to deliver the physical activity intervention at each hospital site</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The number of volunteers retained at the end of the study period (%)</measure>
      <time_frame>through study completion, an average of 3 years</time_frame>
      <description>Feasibility of retaining volunteers to deliver the physical activity intervention at each hospital site</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of trainers retained in each hospital site (%)</measure>
      <time_frame>through study completion, an average of 3 years</time_frame>
      <description>Feasibility of retaining therapists to deliver the intervention at each hospital site.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient's subjective assessment of quality of life - visual analogue scale (VAS)</measure>
      <time_frame>Baseline and post intervention, an average of 2 months</time_frame>
      <description>Quality of life will be measured using the EuroQol (EQ-5D-5L) VAS. The VAS subjectively rates health from 0 (the worst health you can imagine) to 100 (the best health you can imagine).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Grip strength</measure>
      <time_frame>Baseline and post intervention, an average of 2 months</time_frame>
      <description>Grip strength is a simple and accurate measure of muscle function in clinical practice. Grip strength will be measured using the Jamar hand dynamometer, the most widely used instrument in clinical practice with established test-retest, inter-rater and intra-rater reliability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short Physical Performance Battery (SPPB)</measure>
      <time_frame>Baseline and post intervention, an average of 2 months</time_frame>
      <description>The SPPB is a reliable and valid measure of physical function in older people ≥ 60 years and includes exploration of three domains, including walking speed, chair stands, and three progressive balance tasks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>7 days upon recruitment</time_frame>
      <description>Physical activity will be measured using the StepWatch Activity Monitor (SAM; Modus health, Washington, USA), recording daily step count. The SAM is worn on the ankle and is considered an accurate measure of physical activity in older hospitalised patients that engage in low-intensity physical activity and have lower walking speeds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's subjective assessment of quality of life - EuroQol (EQ-5D-5L)</measure>
      <time_frame>Baseline and post intervention, an average of 2 months</time_frame>
      <description>Quality of life will be measured using the EuroQol (EQ-5D-5L) assessment comprising a short descriptive questionnaire. The questionnaire includes 5 domains (e.g., mobility; self-care; usual activities; pain/discomfort; and anxiety/depression) measured with 5 response levels from 'no problems' to 'extreme problems/unable'.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">225</enrollment>
    <condition>Hospital-associated Deconditioning</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Volunteer-led physical activity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Trained volunteers will deliver walking, or bedside exercises with hospitalised older adults twice per day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Volunteer-led physical activity</intervention_name>
      <description>Participants will be assessed by the therapy team who will prescribe tailored activity and then liaise with the mobility volunteers, who will deliver the intervention. Participants who can mobilise independently will be encouraged to perform walking exercises, progressing their walking distance over set markers in the hospital (e.g., to the end of the bed and back; to the doorway and back; to the toilet and back). Participants who require assistance in mobility will perform bed (e.g., hip abduction, static quads), or chair exercises (e.g., ankle pumps, knee extension, arm raise), and will be progressed to performing walking exercises when their physical function improves. Volunteers will check with nursing staff that participants are safe to exercise before each activity session. Participants will receive the mobility sessions twice daily, starting upon recruitment and continuing until the day of discharge from hospital.</description>
      <arm_group_label>Volunteer-led physical activity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  Adults aged 65 years and above&#xD;
  &#xD;
            -  Able to provide written informed consent&#xD;
  &#xD;
          Volunteers&#xD;
  &#xD;
            -  Adults aged 18 years and above&#xD;
  &#xD;
            -  Completed the generic clearance and training with the hospital voluntary services&#xD;
  &#xD;
            -  Able to provide written informed consent&#xD;
  &#xD;
            -  Able to communicate fluently enough in English. Fluent English is required to ensure&#xD;
               the intervention content can be delivered clearly and thus safely to participants.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  Anyone with a severe cognitive impairment (MoCA less than 10)&#xD;
  &#xD;
            -  Patients isolated for infection control reasons&#xD;
  &#xD;
            -  Patients receiving end of life care&#xD;
  &#xD;
          Volunteers&#xD;
  &#xD;
            -  Volunteers that are unable to safely complete the exercises included in the&#xD;
               intervention will be excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Stephen ER Lim, PhD</last_name>
      <phone>+442381206131</phone>
      <email>s.e.lim@soton.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Samantha J Meredith, PhD</last_name>
      <phone>07825104783</phone>
      <email>s.j.meredith@soton.ac.uk</email>
    </overall_contact_backup>
    <reference>
      <citation>Lim S, Ibrahim K, Dodds R, Purkis A, Baxter M, Rogers A, Sayer AA, Roberts HC. Physical activity in hospitalised older people: the feasibility and acceptability of a volunteer-led mobility intervention in the SoMoVe study. Age Ageing. 2020 Feb 27;49(2):283-291. doi: 10.1093/ageing/afz114.</citation>
      <PMID>31566671</PMID>
    </reference>
    <reference>
      <citation>Meredith SJ, Roberts H, Grocott MPW, Jack S, Murphy J, Varkonyi-Sepp J, Bates A, Lim SER. Frail2Fit study protocol: a feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to improve functional outcomes in older adults with frailty after discharge from hospital. BMJ Open. 2023 Mar 16;13(3):e069533. doi: 10.1136/bmjopen-2022-069533.</citation>
      <PMID>36927597</PMID>
    </reference>
    <reference>
      <citation>Lim SER, Meredith S, Agnew S, Clift E, Ibrahim K, Roberts H. Evaluating the feasibility and acceptability of virtual group exercise for older adults delivered by trained volunteers: the ImPACt study protocol. BMJ Open. 2022 Feb 1;12(2):e052631. doi: 10.1136/bmjopen-2021-052631.</citation>
      <PMID>35105576</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Physical activity</keyword>
    <keyword>Hospital-associated deconditioning</keyword>
    <keyword>Sedentary behaviour</keyword>
    <keyword>Physical inactivity</keyword>
    <keyword>Volunteer-led</keyword>
    <keyword>Feasibility</keyword>
    <keyword>Implementation</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017934
  org study id: ERGO 84163
  nct id: NCT06017934
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The PIVOT study will explore the feasibility of training volunteers to deliver exercise to
        hospitalised older adults to improve the health of older people and prevent deconditioning
        while in hospital. Loss of strength and mobility (i.e., deconditioning) is common in
        hospitalised older people and is associated with a decline in physical function, poorer
        quality of life and increased health and care costs. Physical inactivity is an important and
        modifiable risk factor. A previous study showed it is feasible to train volunteers to engage
        with older people in hospital and facilitate walking and bedside exercises. The intervention
        was well-received by older adults, staff members and volunteers. The aim of this study is to
        determine the feasibility of implementing volunteer-led physical activity in three hospitals
        of varying sizes in different regions.
  
        Older adults aged 65 years and above admitted to an acute hospital will be invited to
        participate in the study. The study aims to recruit 180 participants; 90 from three
        intervention sites and 90 from a control site. Participants at the intervention sites will
        receive a twice daily volunteer-led physical activity intervention, and participants at the
        control site will receive usual care.
  
        Participants who are able to mobilise independently will perform walking exercises and
        individuals with mobility impairments will perform bedside exercises. The volunteers will be
        trained and monitored by hospital therapists. The acceptability of the intervention will be
        explored through interviews with patients, volunteers, and staff. Intervention feasibility
        will also be examined through measuring retention of trainers, volunteers, and patients on
        the intervention, and adherence to the exercise.
  
        Study findings will help to determine the feasibility of the volunteer-led physical activity
        intervention across different sized hospitals, voluntary service teams, and therapy services
        to explore the implementation and roll out of the intervention across NHS sites and the
        development of a toolkit to support knowledge transfer.
  Aim The aim of the current research is to explore whether volunteers can be trained to
        deliver exercise support to older adults across three different sized hospitals in different
        locations. Researchers will also explore if the intervention is accepted by patients,
        volunteers and staff and if it has any benefits on patients' health and functional outcomes
        (e.g., quality of life and muscle strength).
  
        Study Design This is a multicentre feasibility study using mixed methods (i.e., quantitative
        and qualitative measures) to explore the implementation of a volunteer-led physical activity
        intervention to older adults in hospital. The study will include three intervention sites and
        one control site. Feasibility studies are used to determine whether an intervention is
        appropriate for further evaluation, to determine sample sizes for controlled trials and to
        assess whether the ideas and findings can be shaped to be relevant and sustainable.
  
        Sample Size A sample size of 180 patients, 90 intervention (30 from each intervention site)
        and 90 from the control site, was chosen in line with previous sample size recommendations
        for feasibility studies of 24-50 participants. This sample size was considered an appropriate
        number that is pragmatic and achievable within the study timescale and resources available at
        each site.
  
        This research aims to recruit 15 volunteers at each site to provide sufficient cover to
        deliver the intervention. In a previous study (SoMoVe trial) 17 volunteers were recruited, 16
        completed training and 12 were retained.
  
        Recruitment and Consent Older adults with an acute medical admission to four hospitals will
        be screened for eligibility by research nurses. Eligible patients will be introduced to the
        study by ward staff. Those who are interested in the study will be approached by the research
        team for further information and information sheets will be provided. Written informed
        consent will be obtained from all patients who agree to participate in the study.
  
        Volunteers will be invited by hospital voluntary services within each hospital site. The
        voluntary services team will send the interested volunteers details to the research team, who
        will then get in contact to complete informed consent.
  
        Inclusion and Exclusion Criteria Patients: The inclusion criteria are adults aged 65 years
        and above who are able to provide informed consent. Exclusion criteria are anyone with a
        severe cognitive impairment (MoCA less than 10), patients isolated for infection control
        reasons, and patients receiving end of life care.
  
        Volunteers: The inclusion criteria for volunteers are age 18 years and above, who have
        completed the generic clearance and training with the hospital voluntary services, who can
        provide written informed consent, and are able to communicate fluently enough in English.
        Fluent English is required to ensure the intervention content can be delivered clearly and
        thus safely to participants. Volunteers that are unable to safely complete the exercises
        included in the intervention will be excluded from the study.
  
        Intervention The exercises were developed based on clinical expertise from therapists and
        from our previous research of volunteer-led mobility interventions in hospital (SoMoVe
        study). Participants will be assessed by the therapy team who will prescribe tailored
        activity and then liaise with the mobility volunteers, who will deliver the intervention.
        Participants who can mobilise independently will be encouraged to perform walking exercises,
        progressing their walking distance over set markers in the hospital (e.g., to the end of the
        bed and back; to the doorway and back; to the toilet and back). Participants who require
        assistance in mobility will perform bed (e.g., hip abduction, static quads), or chair
        exercises (e.g., ankle pumps, knee extension, arm raise), and will be progressed to
        performing walking exercises when their physical function improves. Volunteers will check
        with nursing staff that participants are safe to exercise before each activity session.
        Participants will receive the mobility sessions twice daily, starting upon recruitment and
        continuing until the day of discharge from hospital.
  
        Training The volunteer training package was developed by a clinician and therapist and will
        cover topics including patient and personal safety, mobility and exercise training, and
        response to adverse evets, such as falls. Volunteers will participate in practical sessions
        to practice the exercises with peers. When ready, volunteers will work with patients,
        initially under close supervision and when deemed competent by the trainer, they will be
        encouraged to support mobility sessions independently. A volunteer competency checklist will
        be completed and signed off by the trainer before volunteers work independently. The training
        will be delivered by a physiotherapist in each intervention site.
  
        Fidelity Checks Throughout the study period, fidelity checks will be conducted by the
        trainers once every 2 weeks to ensure that the volunteers are delivering high quality and
        safe exercise. The volunteers will be observed and assessed against a competency and
        implementation checklist, including personal safety, basic patient safety, pre-intervention
        tasks (e.g., safe set up of exercise space), and exercise delivery (e.g., showing safe and
        effective exercise technique). Volunteers will be asked to keep an attendance record during
        the intervention using session completion logs. Regular monthly volunteer meetings will be
        scheduled online to discuss experiences and gain feedback from peers and trainers. Based upon
        fidelity checks and volunteer feedback, extra one-to-one training sessions will be available
        if necessary. The principle investigator will also visit intervention sites to observe and
        liaise with volunteers and trainers.
  
        Data Collection Data including age, sex, co-morbidities, medications, functional status, and
        cognition will provide participants' baseline characteristics in both intervention and
        control sites.
  
        Volunteer data including age, occupation, qualifications, volunteering experience, any
        physiotherapy, sport or therapeutic experience, and employment status will be collected. Data
        on the study sites including hospital size, size of voluntary service team, the number of
        hospital volunteers, and information on the therapy services and what usual care looks like
        will be collected to provide contextual information.
  
        The primary outcome measures are feasibility (can it be done?) and acceptability (will
        volunteers, staff, and patients accept and embrace the programme?) of the intervention.
  
        Feasibility will be assessed by:
  
          1. Number of trainers trained and retained in each hospital site (total number and %)
  
          2. Number of volunteers recruited, trained, and retained (total number and %)
  
          3. Recruitment rate (%) of participants in each site
  
          4. Adherence to the intervention (total number and %)
  
        Acceptability will be assessed through process evaluation involving:
  
          1. Observation and monitoring of volunteer training
  
          2. Interviews with therapy managers to establish usual care in each site
  
          3. Observation of the interaction between volunteers, patients, and healthcare
             professionals on the wards, including contextual factors that may potentially influence
             the delivery and receipt of the intervention.
  
        Qualitative interviews will be conducted with service managers, therapy managers, patients,
        nurses, ward therapists, and volunteers from all study sites, to determine the acceptability
        of the intervention. Purposive sampling will be conducted to capture a range of experiences
        and opinions from patients of varying age and mobility levels, staff with varying seniority
        and gender mix, and volunteers with a range of volunteering experience, age groups, and
        gender mix. The interviews will explore barriers and facilitators to the implementation of
        the intervention into routine clinical practice.
  
        Fidelity Assessment Fidelity assessment will be conducted across all study sites to ensure
        that the exercises and prescribed dose are delivered by the volunteers as prescribed.
        Volunteers will be trained to document each physical activity session in participant exercise
        diaries, detailing whether all the exercises were carried out as prescribed, or whether some
        exercises were excluded, and reasons for exclusions. The exercise diaries will be affixed to
        participants' activity prescription sheet. Further assessments of fidelity of volunteer
        training and the intervention will be conducted through site visits by the research fellow
        once every 2 months and to address any issues that arise.
  
        Secondary Outcome Measures The secondary outcome measures will include assessment of physical
        activity levels (StepWatch Activity Monitor; SAM; Modus health, Washington, USA), physical
        function (Short Physical Performance Battery and grip strength), and quality of life
        (EuroQol; EQ-5D-5L). Moreover, data on length of hospital stay and hospital readmission will
        be accessed through electronic patient records. Data collection will be conducted by research
        nurses, supported by the local principal investigators.
  
        Data Analysis Primary Outcome Analyses Participants' baseline characteristics will be
        described using summary statistics, including mean (standard deviations), medians
        (interquartile ranges), counts and proportions, as appropriate. Statistical analysis will be
        conducted using the statistical software SPSS. Summary statistics will be used to describe
        the feasibility of recruiting, training, and retaining the trainers, the volunteers and study
        participants. Participants' exercise diaries will be analysed to determine how many physical
        activity sessions were offered and the number and percentage of completed sessions.
  
        Data collected from the interviews will be transcribed verbatim and analysed using thematic
        analysis (TA). The audio- recordings will be transcribed by an administrative colleague
        within the research department who is experienced in transcribing qualitative data. TA is a
        method for identifying, analysing and reporting patterns or themes within data and is widely
        used in qualitative research. Transcribed text will be read and coded separately and then
        together by two researchers. The codes will be analysed to generate concepts and ideas to
        determine the acceptability of the intervention, and to identify facilitators and barriers to
        the implementation process. The codes act as tags or labels to help catalogue key concepts
        embedded within the raw data. From the codes, themes will be developed to reflect the views
        and experiences of the older adults and volunteers regarding the volunteer-led physical
        activity intervention.
  
        Secondary Outcome Analyses Daily step count, Short Physical Performance Battery, grip
        strength, and quality of life measured on recruitment and discharge, and length of hospital
        stay will be analysed as continuous variables. The completion rate of each data item will be
        measured. The distribution of each outcome measure will be assessed for normality and
        described using parametric or non-parametric statistics accordingly. Hospital readmission in
        3 and 6 months will be analysed as a categorical variable. Where there is missing data, the
        main analyses will be based on available data.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Qualitative interview data exploring the acceptability of the intervention, including barriers and enablers to the implementation of the intervention.
  time frame: through intervention completion, an average of 2 months
  description: Qualitative interviews will be conducted with service managers, therapy managers, patients, nurses, ward therapists, and volunteers from all study sites, to determine the acceptability of the intervention.
  measure: The number of volunteers recruited to the study (%).
  time frame: through study completion, an average of 3 years
  description: Feasibility of recruiting volunteers to deliver the physical activity intervention at each hospital site
  measure: Number of trainers trained in each hospital site (%)
  time frame: through study completion, an average of 3 years
  description: Feasibility of recruiting therapists to deliver the intervention at each hospital site.
  measure: Adherence to the intervention (%)
  time frame: through study completion, an average of 3 years
  description: The number of participants retained in the intervention at each hospital site.
  measure: Recruitment rate (%) of participants in each site
  time frame: through study completion, an average of 3 years
  description: Feasibility of recruiting older adults onto the volunteer-led physical activity intervention at each hospital site.
  measure: The number of volunteers trained at the end of the study period (%)
  time frame: through study completion, an average of 3 years
  description: Feasibility of training volunteers to deliver the physical activity intervention at each hospital site
  measure: The number of volunteers retained at the end of the study period (%)
  time frame: through study completion, an average of 3 years
  description: Feasibility of retaining volunteers to deliver the physical activity intervention at each hospital site
  measure: Number of trainers retained in each hospital site (%)
  time frame: through study completion, an average of 3 years
  description: Feasibility of retaining therapists to deliver the intervention at each hospital site.
  measure: Patient's subjective assessment of quality of life - visual analogue scale (VAS)
  time frame: Baseline and post intervention, an average of 2 months
  description: Quality of life will be measured using the EuroQol (EQ-5D-5L) VAS. The VAS subjectively rates health from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
  measure: Grip strength
  time frame: Baseline and post intervention, an average of 2 months
  description: Grip strength is a simple and accurate measure of muscle function in clinical practice. Grip strength will be measured using the Jamar hand dynamometer, the most widely used instrument in clinical practice with established test-retest, inter-rater and intra-rater reliability.
  measure: Short Physical Performance Battery (SPPB)
  time frame: Baseline and post intervention, an average of 2 months
  description: The SPPB is a reliable and valid measure of physical function in older people ≥ 60 years and includes exploration of three domains, including walking speed, chair stands, and three progressive balance tasks.
  measure: Physical activity
  time frame: 7 days upon recruitment
  description: Physical activity will be measured using the StepWatch Activity Monitor (SAM; Modus health, Washington, USA), recording daily step count. The SAM is worn on the ankle and is considered an accurate measure of physical activity in older hospitalised patients that engage in low-intensity physical activity and have lower walking speeds.
  measure: Patient's subjective assessment of quality of life - EuroQol (EQ-5D-5L)
  time frame: Baseline and post intervention, an average of 2 months
  description: Quality of life will be measured using the EuroQol (EQ-5D-5L) assessment comprising a short descriptive questionnaire. The questionnaire includes 5 domains (e.g., mobility; self-care; usual activities; pain/discomfort; and anxiety/depression) measured with 5 response levels from 'no problems' to 'extreme problems/unable'.
  arm group label: Control
  arm group type: No Intervention
  description: Usual care
  arm group label: Volunteer-led physical activity
  arm group type: Experimental
  description: Trained volunteers will deliver walking, or bedside exercises with hospitalised older adults twice per day.
  intervention type: Behavioral
  intervention name: Volunteer-led physical activity
  description: Participants will be assessed by the therapy team who will prescribe tailored activity and then liaise with the mobility volunteers, who will deliver the intervention. Participants who can mobilise independently will be encouraged to perform walking exercises, progressing their walking distance over set markers in the hospital (e.g., to the end of the bed and back; to the doorway and back; to the toilet and back). Participants who require assistance in mobility will perform bed (e.g., hip abduction, static quads), or chair exercises (e.g., ankle pumps, knee extension, arm raise), and will be progressed to performing walking exercises when their physical function improves. Volunteers will check with nursing staff that participants are safe to exercise before each activity session. Participants will receive the mobility sessions twice daily, starting upon recruitment and continuing until the day of discharge from hospital.
  arm group label: Volunteer-led physical activity
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stephen ER Lim, PhD
  phone: +442381206131
  email: s.e.lim@soton.ac.uk
  last name: Samantha J Meredith, PhD
  phone: 07825104783
  email: s.j.meredith@soton.ac.uk
  citation: Lim S, Ibrahim K, Dodds R, Purkis A, Baxter M, Rogers A, Sayer AA, Roberts HC. Physical activity in hospitalised older people: the feasibility and acceptability of a volunteer-led mobility intervention in the SoMoVe study. Age Ageing. 2020 Feb 27;49(2):283-291. doi: 10.1093/ageing/afz114.
  PMID: 31566671
  citation: Meredith SJ, Roberts H, Grocott MPW, Jack S, Murphy J, Varkonyi-Sepp J, Bates A, Lim SER. Frail2Fit study protocol: a feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to improve functional outcomes in older adults with frailty after discharge from hospital. BMJ Open. 2023 Mar 16;13(3):e069533. doi: 10.1136/bmjopen-2022-069533.
  PMID: 36927597
  citation: Lim SER, Meredith S, Agnew S, Clift E, Ibrahim K, Roberts H. Evaluating the feasibility and acceptability of virtual group exercise for older adults delivered by trained volunteers: the ImPACt study protocol. BMJ Open. 2022 Feb 1;12(2):e052631. doi: 10.1136/bmjopen-2021-052631.
  PMID: 35105576
  responsible party type: Sponsor
  sharing ipd: No