<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/NCT03001232</url>
  </required_header>
  <id_info>
    <org_study_id>METc Vumc: 2013.311/A2015.245</org_study_id>
    <nct_id>NCT03001232</nct_id>
  </id_info>
  <brief_title>The Effect of Movement-oriented Dementia Care on ADL and QoL of Dementia Patients in Nursing Homes</brief_title>
  <acronym>Solis MDC</acronym>
  <official_title>Enriched Environment and Dementia: The Effect of an Individual Daily Calendar on the Activity Level and Mental Functions of Persons With Dementia in a Nursing Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VU University of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zorggroep Solis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VU University of Amsterdam</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether movement-oriented dementia care has a&#xD;
      positive effect on quality of life and independence in activities of daily living (ADL) in&#xD;
      nursing-home residents with dementia.&#xD;
&#xD;
      It was hypothesized that movement-oriented dementia care has a positive effect on quality of&#xD;
      life and independence in ADL, as well as on mood, behavior, cognition and physical&#xD;
      functioning, in comparison to regular care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      In the Netherlands, an estimated number of 70.000 patients with dementia are&#xD;
      institutionalized. This number is expected to increase rapidly in the coming years due to the&#xD;
      aging population. Loss of independence in activities of daily living (ADL) is an important&#xD;
      predictor for institutionalization and an important determinant for the quality of life. Once&#xD;
      institutionalized, independence in ADL tends to decline even more rapid.This rapid decline&#xD;
      may be due to insufficient stimulation of the patients' remaining abilities. Underestimating&#xD;
      the patient's abilities may contribute to the inactive lifestyle in nursing homes. An&#xD;
      inactive lifestyle negatively affects multiple disease outcomes. In the present study,&#xD;
      movement-oriented dementia care (MDC) is implemented on psychogeriatric wards of a Dutch&#xD;
      nursing home. MDC focuses on the integration of physical activity in the daily lives of&#xD;
      nursing home residents with dementia. The key element of MDC is the multidisciplinary&#xD;
      approach to ensure physical stimulation at all times. The following disciplines are involved&#xD;
      in MDC: nursing staff, department heads, paramedics (physiotherapists and occupational&#xD;
      therapists), psychologists, geriatrics specialists, activity leaders, volunteers and family&#xD;
      caregivers. The primary aim is to evaluate the effect of MDC on ADL independence and quality&#xD;
      of life. Additionally, the effect on mood, behaviour, cognition, and physical fitness is&#xD;
      investigated.&#xD;
&#xD;
      The present study was a non-randomized 12-month longitudinal study with two parallel groups.&#xD;
      The study was approved by the Medical Ethical Exam Committee (METc) of the VUmc.&#xD;
&#xD;
      Participants were residents from five psychogeriatric wards of two locations of nursing home&#xD;
      Solis in Deventer. All participants were diagnosed with dementia.&#xD;
&#xD;
      Recruitment: In the first place, the staff of Nursing home Solis was informed about the&#xD;
      intervention. Consequently, an initial selection of suitable clients took place. Clients&#xD;
      receiving palliative care did not participate in the study. Suitable clients and their&#xD;
      caregivers were informed about the study by means of an informative presentation as well as&#xD;
      an informative letter in which clients and their caregivers were asked to give informed&#xD;
      consent.&#xD;
&#xD;
      Randomisation:Two locations of nursing home Solis were non-randomly allocated to the&#xD;
      experimental or control condition. Participants living at the experimental location received&#xD;
      movement-oriented dementia care (MDC), while participants living at the control location&#xD;
      received care as usual.&#xD;
&#xD;
      Procedure: Movement-oriented Dementia Care was given to as many residents as possible from&#xD;
      the psychogeriatric wards of the intervention location. In order to properly implement&#xD;
      movement-oriented care, nursing staff, activity leaders and living room staff were offered a&#xD;
      schooling aimed at increasing awareness of the importance of movement, as well as providing&#xD;
      tools for stimulating movement in elderly with dementia. Caregivers and volunteers received&#xD;
      information about movement during an information meeting. The execution of the&#xD;
      movement-oriented care differed per discipline. Nursing staff continuously encouraged clients&#xD;
      to function as independently as possible. This regards activities such as getting dressed,&#xD;
      preparing meals, pouring coffee, and toilet use. Paramedics coached the nursing staff by&#xD;
      specifying medical and physical limits of each participant. Additionally, they gave advice on&#xD;
      how to handle specific situations. They also informed and coached caregivers on how to safely&#xD;
      stimulate movement with clients. Based on these advises, a plan was created for each resident&#xD;
      to determine the daily routines that they are capable of performing, as well as how to&#xD;
      stimulate the participants to engage in physical activities. Activity leaders were informed&#xD;
      on how to include movement interventions in their activities. In addition, activity leaders&#xD;
      constructed a leisure-care calendar focusing on general activities based on personal&#xD;
      preferences and potentials. Family caregivers and volunteers were encouraged to stimulate&#xD;
      physical activity of the patients in general.&#xD;
&#xD;
      Nursing staff were trained by an expert in MDC (three sessions of three hours), in order to&#xD;
      increase awareness of the importance of physical activity, as well as the role of physical&#xD;
      activity in ADL. Additionally, paramedics received a two-hour meeting informing them on their&#xD;
      role in advising nursing staff. Volunteers and family caregivers were informed about the&#xD;
      benefits of an active lifestyle during several open meetings.&#xD;
&#xD;
      The outcome variables were measured 5 times, i.e. at baseline and after 3, 6, 9, and 12&#xD;
      months of the intervention. Trained physiotherapists performed the measurements with&#xD;
      participants, while nursing staff and caregivers were asked to fill in questionnaires. The&#xD;
      test battery administered by the clients had a maximum duration of 30 to 45 minutes, in which&#xD;
      the client was free to take breaks.&#xD;
&#xD;
      To ensure compliance to the intervention, one staff member at each psychogeriatric ward&#xD;
      became an 'ambassador' of MDC, responsible for implementation at their ward. Process&#xD;
      evaluations were administered for nursing staff and caregivers every three months to measure&#xD;
      the extent of implementation. These process evaluations consisted of structured interviews&#xD;
      and questionnaires. Questionnaires were completed by nursing staff and family caregivers&#xD;
      every three months. Structured interviews were conducted with members of a multidisciplinary&#xD;
      focus group after three and nine months. The focus group consisted of 12 professionals;&#xD;
      nurses, activity leaders, heads of the departments, 'ambassadors', a physiotherapist and an&#xD;
      occupational therapist. The process evaluations focused on the following elements:&#xD;
&#xD;
        -  To which extent did staff and family carers prepare to provide MDC?&#xD;
&#xD;
        -  Which aspects of MDC are applied?&#xD;
&#xD;
        -  Is MDC applied according to its core principles?&#xD;
&#xD;
        -  To what extent are participants stimulated to be physically active?&#xD;
&#xD;
        -  Are the staff and family carers satisfied with the execution of MDC?&#xD;
&#xD;
        -  What barriers are experienced?&#xD;
&#xD;
      The following demographic data was registered per participant: subtype dementia, birth year&#xD;
      (age), sex, education, severity of dementia, comorbidities, cardiovascular risk factors and&#xD;
      medication use.&#xD;
&#xD;
      The severity of dementia was determined using the Mini Mental State Examination (MMSE). The&#xD;
      scores ranged from 0 (severe cognitive impairment) to 30 (no cognitive impairment). The&#xD;
      recommended cut-off point of 24 was applied, with a score of 23 or lower indicating dementia.&#xD;
&#xD;
      Comorbidities were derived from the medical charts of the participants and were categorized&#xD;
      according to the Dutch translation of the Long-Term Care Facility Resident Assessment&#xD;
      Instrument (RAI), section I disease diagnosis. The section consists of 44 subcategories that&#xD;
      belong to eight categories. The sum of the subcategories was used as a comorbidity score.&#xD;
      Information regarding cardiovascular risk factors was derived from the medical charts of the&#xD;
      participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Activities of Daily Living (ADL), measured with the Barthel Index.</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment</time_frame>
    <description>The Barthel Index is a survey consisting of 10 performance items (e.g. toilet use, dressing) rated on an ordinal scale (two-point, three-point or four-point scale), indicating the level of help needed. Scores range from 0 to 20, with higher scores representing a higher level of functional independence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Quality of Life (QoL), measured with the Qualidem</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment</time_frame>
    <description>The Qualidem is a questionnaire with 40 items of observable behaviour rated on a four-point rating scale, ranging from 1 (never) to 4 (often). There is no total score; scores can only be obtained for the nine subscales. For each subscale, a higher score represented a better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in general cognitive functions, measured with the Severe Impairment Battery 8 (SIB-8).</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment.</time_frame>
    <description>The SIB-8 consists of eight questions measuring orientation in time, writing, fluency, naming, and attention. Scores range from 0 to 16, with higher scores indicating better cognitive functions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in mood, measured with the Cornell Scale for Depression in Dementia (CSDD).</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment</time_frame>
    <description>The CSDD consists of 30 questions rated on a two-point scale ranging from 0 (absent) to 2 (severe). Scores range from 0 to 38, with higher scores representing a higher level of depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in behaviour, measured with the Apathy Evaluation Scale-10 (AES-10).</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment.</time_frame>
    <description>The AES-10 is a selection of 10 items from the original AES, which were applicable to nursing home residents. The items represent behaviours (contra) indicative for apathy (e.g. being motivated). Each item is rated on a four-point scale, ranging from 1 (not characteristic) to 4 (very characteristic). Scores range from 10 to 40, which higher scores representing more apathetic behaviour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in behaviour, measured with the Cohen-Mansfield Agitation Inventory (CMAI).</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment.</time_frame>
    <description>The CMAI is a questionnaire consisting of 29 items representing types of agitated behaviour, rated on a seven-point scale. Higher scores indicate more agitated behaviour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in aerobic fitness, measured with the two minute walking test (2mWT).</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment</time_frame>
    <description>The participant was requested to walk the largest distance possible during a time period of two minutes. The participant was allowed to use a walking device and take breaks if necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in functional mobility and fall risk, measured with the Timed up and go (TUG).</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment</time_frame>
    <description>The participant was asked to stand up from a chair with armrests, walk three metres, turn around, walk back to the chair, and sit down again. The participant was allowed to use a walking device. The time it took for the participant to perform these steps was recorded by the examiner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in walking speed, measured with the ten meter timed walk.</measure>
    <time_frame>baseline and 3, 6, 9 and 12 months after baseline assessment.</time_frame>
    <description>The participant was asked to walk 10 meters in a comfortable speed. The participant was allowed to use a walking device. The test was repeated three times, where the fastest attempt was used as an outcome measure for walking speed as recorded in metres per second.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Degree of implementation of MDC at each ward measured with process evaluations.</measure>
    <time_frame>3, 6, 9 and 12 months of intervention.</time_frame>
    <description>Process evaluations included both questionnaires and structured interviews. Questionnaires were completed by the nursing staff and family caregivers. Structured interviews were conducted with members of a multidisciplinary focus group</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Movement-oriented Dementia Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group received movement-oriented dementia care for a period of twelve months.Movement-oriented dementia care is a multidisciplinary approach in which all involved disciplines focus on stimulating physical activity and independence as much as possible. This way physical activity is stimulated at all times for the participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group received care as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Movement-oriented Dementia Care</intervention_name>
    <description>The intervention is a new multidisciplinary approach that focuses on optimizing physical activity and independence in daily care and activities. MDC intended to incorporate all persons surrounding the patients. The nursing staff was intensively trained by an expert in MDC, and played a central role in continuously stimulating patients to function as independently as possible. Geriatric physicians and physiotherapists advised the nursing staff about participants' medical and physical limitations to ensure safe stimulation. Consequently, a plan was created for each resident to determine the daily routines they were capable of performing themselves. Caregivers and volunteers were informed about the benefits of an active lifestyle during several open meetings.</description>
    <arm_group_label>Movement-oriented Dementia Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of dementia (based on medical charts)&#xD;
&#xD;
          -  Living in a psychogeriatric ward of Solis for at least three weeks&#xD;
&#xD;
          -  65 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Very bad vision&#xD;
&#xD;
          -  Psychotic symptoms&#xD;
&#xD;
          -  A palliative care protocol&#xD;
&#xD;
          -  A score on the Mini-Mental State Examination (MMSE) of 25 or higher&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marinda Henskens, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>VU University of Amsterdam</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erik JA Scherder, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>VU University of Amsterdam</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan Vrijkotte, Msc</last_name>
    <role>Study Director</role>
    <affiliation>Zorggroep Solis</affiliation>
  </overall_official>
  <reference>
    <citation>Ballard C, O'Brien J, James I, Mynt P, Lana M, Potkins D, Reichelt K, Lee L, Swann A, Fossey J. Quality of life for people with dementia living in residential and nursing home care: the impact of performance on activities of daily living, behavioral and psychological symptoms, language skills, and psychotropic drugs. Int Psychogeriatr. 2001 Mar;13(1):93-106. doi: 10.1017/s1041610201007499.</citation>
    <PMID>11352339</PMID>
  </reference>
  <reference>
    <citation>Blankevoort CG, van Heuvelen MJ, Boersma F, Luning H, de Jong J, Scherder EJ. Review of effects of physical activity on strength, balance, mobility and ADL performance in elderly subjects with dementia. Dement Geriatr Cogn Disord. 2010;30(5):392-402. doi: 10.1159/000321357. Epub 2010 Oct 28.</citation>
    <PMID>20980758</PMID>
  </reference>
  <reference>
    <citation>Edwards N, Gardiner M, Ritchie DM, Baldwin K, Sands L. Effect of exercise on negative affect in residents in special care units with moderate to severe dementia. Alzheimer Dis Assoc Disord. 2008 Oct-Dec;22(4):362-8. doi: 10.1097/WAD.0b013e31818ecbbc.</citation>
    <PMID>18978600</PMID>
  </reference>
  <reference>
    <citation>Burge E, Kuhne N, Berchtold A, Maupetit C, von Gunten A. Impact of physical activity on activity of daily living in moderate to severe dementia: a critical review. Eur Rev Aging Phys Act. 2012 Apr;9(1):27-39. doi: 10.1007/s11556-011-0092-y. Epub 2011 Dec 15.</citation>
    <PMID>22639696</PMID>
  </reference>
  <reference>
    <citation>Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.</citation>
    <PMID>20101011</PMID>
  </reference>
  <reference>
    <citation>Kemoun G, Thibaud M, Roumagne N, Carette P, Albinet C, Toussaint L, Paccalin M, Dugue B. Effects of a physical training programme on cognitive function and walking efficiency in elderly persons with dementia. Dement Geriatr Cogn Disord. 2010;29(2):109-14. doi: 10.1159/000272435. Epub 2010 Feb 11.</citation>
    <PMID>20150731</PMID>
  </reference>
  <reference>
    <citation>Morris JN, Fiatarone M, Kiely DK, Belleville-Taylor P, Murphy K, Littlehale S, Ooi WL, O'Neill E, Doyle N. Nursing rehabilitation and exercise strategies in the nursing home. J Gerontol A Biol Sci Med Sci. 1999 Oct;54(10):M494-500. doi: 10.1093/gerona/54.10.m494.</citation>
    <PMID>10568531</PMID>
  </reference>
  <reference>
    <citation>Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT. Determinants of quality of life in nursing home residents with dementia. Dement Geriatr Cogn Disord. 2010;29(3):189-97. doi: 10.1159/000280437. Epub 2010 Mar 6.</citation>
    <PMID>20215750</PMID>
  </reference>
  <reference>
    <citation>Galik E, Resnick B, Hammersla M, Brightwater J. Optimizing function and physical activity among nursing home residents with dementia: testing the impact of function-focused care. Gerontologist. 2014 Dec;54(6):930-43. doi: 10.1093/geront/gnt108. Epub 2013 Oct 3.</citation>
    <PMID>24092822</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VU University of Amsterdam</investigator_affiliation>
    <investigator_full_name>Marinda Henskens</investigator_full_name>
    <investigator_title>Msc</investigator_title>
  </responsible_party>
  <keyword>Movement-oriented Dementia Care</keyword>
  <keyword>QoL</keyword>
  <keyword>ADL</keyword>
  <keyword>Nursing Home</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03001232
org study id: METc Vumc: 2013.311/A2015.245
nct id: NCT03001232
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether movement-oriented dementia care has a
      positive effect on quality of life and independence in activities of daily living (ADL) in
      nursing-home residents with dementia.

      It was hypothesized that movement-oriented dementia care has a positive effect on quality of
      life and independence in ADL, as well as on mood, behavior, cognition and physical
      functioning, in comparison to regular care.
Background:

      In the Netherlands, an estimated number of 70.000 patients with dementia are
      institutionalized. This number is expected to increase rapidly in the coming years due to the
      aging population. Loss of independence in activities of daily living (ADL) is an important
      predictor for institutionalization and an important determinant for the quality of life. Once
      institutionalized, independence in ADL tends to decline even more rapid.This rapid decline
      may be due to insufficient stimulation of the patients' remaining abilities. Underestimating
      the patient's abilities may contribute to the inactive lifestyle in nursing homes. An
      inactive lifestyle negatively affects multiple disease outcomes. In the present study,
      movement-oriented dementia care (MDC) is implemented on psychogeriatric wards of a Dutch
      nursing home. MDC focuses on the integration of physical activity in the daily lives of
      nursing home residents with dementia. The key element of MDC is the multidisciplinary
      approach to ensure physical stimulation at all times. The following disciplines are involved
      in MDC: nursing staff, department heads, paramedics (physiotherapists and occupational
      therapists), psychologists, geriatrics specialists, activity leaders, volunteers and family
      caregivers. The primary aim is to evaluate the effect of MDC on ADL independence and quality
      of life. Additionally, the effect on mood, behaviour, cognition, and physical fitness is
      investigated.

      The present study was a non-randomized 12-month longitudinal study with two parallel groups.
      The study was approved by the Medical Ethical Exam Committee (METc) of the VUmc.

      Participants were residents from five psychogeriatric wards of two locations of nursing home
      Solis in Deventer. All participants were diagnosed with dementia.

      Recruitment: In the first place, the staff of Nursing home Solis was informed about the
      intervention. Consequently, an initial selection of suitable clients took place. Clients
      receiving palliative care did not participate in the study. Suitable clients and their
      caregivers were informed about the study by means of an informative presentation as well as
      an informative letter in which clients and their caregivers were asked to give informed
      consent.

      Randomisation:Two locations of nursing home Solis were non-randomly allocated to the
      experimental or control condition. Participants living at the experimental location received
      movement-oriented dementia care (MDC), while participants living at the control location
      received care as usual.

      Procedure: Movement-oriented Dementia Care was given to as many residents as possible from
      the psychogeriatric wards of the intervention location. In order to properly implement
      movement-oriented care, nursing staff, activity leaders and living room staff were offered a
      schooling aimed at increasing awareness of the importance of movement, as well as providing
      tools for stimulating movement in elderly with dementia. Caregivers and volunteers received
      information about movement during an information meeting. The execution of the
      movement-oriented care differed per discipline. Nursing staff continuously encouraged clients
      to function as independently as possible. This regards activities such as getting dressed,
      preparing meals, pouring coffee, and toilet use. Paramedics coached the nursing staff by
      specifying medical and physical limits of each participant. Additionally, they gave advice on
      how to handle specific situations. They also informed and coached caregivers on how to safely
      stimulate movement with clients. Based on these advises, a plan was created for each resident
      to determine the daily routines that they are capable of performing, as well as how to
      stimulate the participants to engage in physical activities. Activity leaders were informed
      on how to include movement interventions in their activities. In addition, activity leaders
      constructed a leisure-care calendar focusing on general activities based on personal
      preferences and potentials. Family caregivers and volunteers were encouraged to stimulate
      physical activity of the patients in general.

      Nursing staff were trained by an expert in MDC (three sessions of three hours), in order to
      increase awareness of the importance of physical activity, as well as the role of physical
      activity in ADL. Additionally, paramedics received a two-hour meeting informing them on their
      role in advising nursing staff. Volunteers and family caregivers were informed about the
      benefits of an active lifestyle during several open meetings.

      The outcome variables were measured 5 times, i.e. at baseline and after 3, 6, 9, and 12
      months of the intervention. Trained physiotherapists performed the measurements with
      participants, while nursing staff and caregivers were asked to fill in questionnaires. The
      test battery administered by the clients had a maximum duration of 30 to 45 minutes, in which
      the client was free to take breaks.

      To ensure compliance to the intervention, one staff member at each psychogeriatric ward
      became an 'ambassador' of MDC, responsible for implementation at their ward. Process
      evaluations were administered for nursing staff and caregivers every three months to measure
      the extent of implementation. These process evaluations consisted of structured interviews
      and questionnaires. Questionnaires were completed by nursing staff and family caregivers
      every three months. Structured interviews were conducted with members of a multidisciplinary
      focus group after three and nine months. The focus group consisted of 12 professionals;
      nurses, activity leaders, heads of the departments, 'ambassadors', a physiotherapist and an
      occupational therapist. The process evaluations focused on the following elements:

        -  To which extent did staff and family carers prepare to provide MDC?

        -  Which aspects of MDC are applied?

        -  Is MDC applied according to its core principles?

        -  To what extent are participants stimulated to be physically active?

        -  Are the staff and family carers satisfied with the execution of MDC?

        -  What barriers are experienced?

      The following demographic data was registered per participant: subtype dementia, birth year
      (age), sex, education, severity of dementia, comorbidities, cardiovascular risk factors and
      medication use.

      The severity of dementia was determined using the Mini Mental State Examination (MMSE). The
      scores ranged from 0 (severe cognitive impairment) to 30 (no cognitive impairment). The
      recommended cut-off point of 24 was applied, with a score of 23 or lower indicating dementia.

      Comorbidities were derived from the medical charts of the participants and were categorized
      according to the Dutch translation of the Long-Term Care Facility Resident Assessment
      Instrument (RAI), section I disease diagnosis. The section consists of 44 subcategories that
      belong to eight categories. The sum of the subcategories was used as a comorbidity score.
      Information regarding cardiovascular risk factors was derived from the medical charts of the
      participants.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change from Baseline in Activities of Daily Living (ADL), measured with the Barthel Index.
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment
description: The Barthel Index is a survey consisting of 10 performance items (e.g. toilet use, dressing) rated on an ordinal scale (two-point, three-point or four-point scale), indicating the level of help needed. Scores range from 0 to 20, with higher scores representing a higher level of functional independence.
measure: Change from Baseline in Quality of Life (QoL), measured with the Qualidem
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment
description: The Qualidem is a questionnaire with 40 items of observable behaviour rated on a four-point rating scale, ranging from 1 (never) to 4 (often). There is no total score; scores can only be obtained for the nine subscales. For each subscale, a higher score represented a better quality of life.
measure: Change from Baseline in general cognitive functions, measured with the Severe Impairment Battery 8 (SIB-8).
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment.
description: The SIB-8 consists of eight questions measuring orientation in time, writing, fluency, naming, and attention. Scores range from 0 to 16, with higher scores indicating better cognitive functions
measure: Change from Baseline in mood, measured with the Cornell Scale for Depression in Dementia (CSDD).
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment
description: The CSDD consists of 30 questions rated on a two-point scale ranging from 0 (absent) to 2 (severe). Scores range from 0 to 38, with higher scores representing a higher level of depressive symptoms.
measure: Change from Baseline in behaviour, measured with the Apathy Evaluation Scale-10 (AES-10).
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment.
description: The AES-10 is a selection of 10 items from the original AES, which were applicable to nursing home residents. The items represent behaviours (contra) indicative for apathy (e.g. being motivated). Each item is rated on a four-point scale, ranging from 1 (not characteristic) to 4 (very characteristic). Scores range from 10 to 40, which higher scores representing more apathetic behaviour.
measure: Change from Baseline in behaviour, measured with the Cohen-Mansfield Agitation Inventory (CMAI).
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment.
description: The CMAI is a questionnaire consisting of 29 items representing types of agitated behaviour, rated on a seven-point scale. Higher scores indicate more agitated behaviour.
measure: Change from Baseline in aerobic fitness, measured with the two minute walking test (2mWT).
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment
description: The participant was requested to walk the largest distance possible during a time period of two minutes. The participant was allowed to use a walking device and take breaks if necessary.
measure: Change from Baseline in functional mobility and fall risk, measured with the Timed up and go (TUG).
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment
description: The participant was asked to stand up from a chair with armrests, walk three metres, turn around, walk back to the chair, and sit down again. The participant was allowed to use a walking device. The time it took for the participant to perform these steps was recorded by the examiner.
measure: Change from Baseline in walking speed, measured with the ten meter timed walk.
time frame: baseline and 3, 6, 9 and 12 months after baseline assessment.
description: The participant was asked to walk 10 meters in a comfortable speed. The participant was allowed to use a walking device. The test was repeated three times, where the fastest attempt was used as an outcome measure for walking speed as recorded in metres per second.
measure: Degree of implementation of MDC at each ward measured with process evaluations.
time frame: 3, 6, 9 and 12 months of intervention.
description: Process evaluations included both questionnaires and structured interviews. Questionnaires were completed by the nursing staff and family caregivers. Structured interviews were conducted with members of a multidisciplinary focus group
arm group label: Movement-oriented Dementia Care
arm group type: Experimental
description: The experimental group received movement-oriented dementia care for a period of twelve months.Movement-oriented dementia care is a multidisciplinary approach in which all involved disciplines focus on stimulating physical activity and independence as much as possible. This way physical activity is stimulated at all times for the participants.
arm group label: Care as usual
arm group type: No Intervention
description: The control group received care as usual
intervention type: Behavioral
intervention name: Movement-oriented Dementia Care
description: The intervention is a new multidisciplinary approach that focuses on optimizing physical activity and independence in daily care and activities. MDC intended to incorporate all persons surrounding the patients. The nursing staff was intensively trained by an expert in MDC, and played a central role in continuously stimulating patients to function as independently as possible. Geriatric physicians and physiotherapists advised the nursing staff about participants' medical and physical limitations to ensure safe stimulation. Consequently, a plan was created for each resident to determine the daily routines they were capable of performing themselves. Caregivers and volunteers were informed about the benefits of an active lifestyle during several open meetings.
arm group label: Movement-oriented Dementia Care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Marinda Henskens, Msc
role: Principal Investigator
affiliation: VU University of Amsterdam
last name: Erik JA Scherder, Prof. Dr.
role: Principal Investigator
affiliation: VU University of Amsterdam
last name: Susan Vrijkotte, Msc
role: Study Director
affiliation: Zorggroep Solis
citation: Ballard C, O'Brien J, James I, Mynt P, Lana M, Potkins D, Reichelt K, Lee L, Swann A, Fossey J. Quality of life for people with dementia living in residential and nursing home care: the impact of performance on activities of daily living, behavioral and psychological symptoms, language skills, and psychotropic drugs. Int Psychogeriatr. 2001 Mar;13(1):93-106. doi: 10.1017/s1041610201007499.
PMID: 11352339
citation: Blankevoort CG, van Heuvelen MJ, Boersma F, Luning H, de Jong J, Scherder EJ. Review of effects of physical activity on strength, balance, mobility and ADL performance in elderly subjects with dementia. Dement Geriatr Cogn Disord. 2010;30(5):392-402. doi: 10.1159/000321357. Epub 2010 Oct 28.
PMID: 20980758
citation: Edwards N, Gardiner M, Ritchie DM, Baldwin K, Sands L. Effect of exercise on negative affect in residents in special care units with moderate to severe dementia. Alzheimer Dis Assoc Disord. 2008 Oct-Dec;22(4):362-8. doi: 10.1097/WAD.0b013e31818ecbbc.
PMID: 18978600
citation: Burge E, Kuhne N, Berchtold A, Maupetit C, von Gunten A. Impact of physical activity on activity of daily living in moderate to severe dementia: a critical review. Eur Rev Aging Phys Act. 2012 Apr;9(1):27-39. doi: 10.1007/s11556-011-0092-y. Epub 2011 Dec 15.
PMID: 22639696
citation: Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.
PMID: 20101011
citation: Kemoun G, Thibaud M, Roumagne N, Carette P, Albinet C, Toussaint L, Paccalin M, Dugue B. Effects of a physical training programme on cognitive function and walking efficiency in elderly persons with dementia. Dement Geriatr Cogn Disord. 2010;29(2):109-14. doi: 10.1159/000272435. Epub 2010 Feb 11.
PMID: 20150731
citation: Morris JN, Fiatarone M, Kiely DK, Belleville-Taylor P, Murphy K, Littlehale S, Ooi WL, O'Neill E, Doyle N. Nursing rehabilitation and exercise strategies in the nursing home. J Gerontol A Biol Sci Med Sci. 1999 Oct;54(10):M494-500. doi: 10.1093/gerona/54.10.m494.
PMID: 10568531
citation: Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT. Determinants of quality of life in nursing home residents with dementia. Dement Geriatr Cogn Disord. 2010;29(3):189-97. doi: 10.1159/000280437. Epub 2010 Mar 6.
PMID: 20215750
citation: Galik E, Resnick B, Hammersla M, Brightwater J. Optimizing function and physical activity among nursing home residents with dementia: testing the impact of function-focused care. Gerontologist. 2014 Dec;54(6):930-43. doi: 10.1093/geront/gnt108. Epub 2013 Oct 3.
PMID: 24092822
responsible party type: Principal Investigator
investigator affiliation: VU University of Amsterdam
investigator full name: Marinda Henskens
investigator title: Msc
mesh term: Dementia
sharing ipd: No