<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/NCT04469374</url>
  </required_header>
  <id_info>
    <org_study_id>StaffsUni1</org_study_id>
    <nct_id>NCT04469374</nct_id>
  </id_info>
  <brief_title>Menopause Osteoporosis and Bone Intervention Using Lifestyle Exercise.</brief_title>
  <acronym>MOBILE</acronym>
  <official_title>The Effect of an Exercise Intervention for Preventing Osteoporosis Among Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Staffordshire University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Staffordshire University</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>
      Aim: to examine the effect of an exercise intervention for preventing osteoporosis among&#xD;
      postmenopausal women.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To examine whether mean values for Broadband Ultrasound Attenuation (BUA) using Quantitative&#xD;
      Ultrasound (QUS) among postmenopausal women following an eight-month exercise intervention&#xD;
      (and at 3-month follow up), will be significantly higher than those obtained&#xD;
      pre-intervention.&#xD;
&#xD;
      To examine whether mean BUA values among postmenopausal women following an eight-month&#xD;
      exercise intervention (and at 3-month follow up) will be significantly higher than mean&#xD;
      values obtained from participants in a control group undertaking sham exercises for an&#xD;
      equivalent duration.&#xD;
&#xD;
      To examine the feasibility of the eight-month exercise intervention for a potential larger&#xD;
      study (larger sample size, increased number of trial arms and increased outcome measures), in&#xD;
      terms of recruitment, adherence, perceptions, barriers, and acceptability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data will be collected at baseline, on study completion and at 3-month follow-up. Sequel to&#xD;
      baseline data collection and ascertainment of eligibility, participants will be randomised&#xD;
      into either the exercise intervention group or sham-control group. Randomisation will be&#xD;
      through computer-generation of random numbers. Participants will be blinded to group&#xD;
      allocation. Both groups will complete their required programme for eight months.&#xD;
&#xD;
      For the intervention group, participants will be required to perform 10 maximal vertical&#xD;
      jumps, with a 10-s rest interval between each jump, using an arm swing in countermovement&#xD;
      style on three days per week. The jumps will be performed without shoes on a hard surface.&#xD;
      The jumps will be preceded by a warm-up lasting approximately 3 min and consisting of&#xD;
      mobilisation exercises for the legs and lower back. Jumping will be progressed over time and&#xD;
      in accordance with individual needs. Initially, jumping may be undertaken with the use of a&#xD;
      handheld support (such as the back of a chair or table), should participants feel unstable.&#xD;
      Jumps will be progressed to include multi-directional movements (jumping to the side,&#xD;
      forwards, backwards, and diagonally). Natural progression will also occur as participants&#xD;
      should improve their jump height with increased muscular explosiveness. Participants will be&#xD;
      asked to fill out a simple, daily training log, stipulating when they have undertaken the&#xD;
      exercise, in order for adherence to be assessed.&#xD;
&#xD;
      In the control group, participants will be required to perform balance exercises. The&#xD;
      balancing exercises will be progressed and varied (to ensure adherence). Initially, the use&#xD;
      of a handheld support (such as the back of the chair) can be used. Participants will be&#xD;
      required to balance on one leg for up to 60 seconds (2 x 60 s is equivalent in duration to&#xD;
      the 10 jumps). This exercise will initially be progressed using time, and then by doing the&#xD;
      following: confounding the visual fixation (e.g., head turns), changing the centre of mass&#xD;
      (e.g. arm/leg lifts); performing the stork balance (hands on hips, knee bent and supported by&#xD;
      standing leg); reaching in multiple directions before regaining the initial stance; closing&#xD;
      the eyes; reducing the base of support; and a combination of these activities. The starting&#xD;
      level of difficulty will be prescribed by the researcher, according to each participant's&#xD;
      functional ability. The balance exercises will be preceded by a warm-up lasting approximately&#xD;
      3 min and consisting of mobilisation exercises for the legs and lower back. The purpose of&#xD;
      the sham exercise is to foster the perception of full participation in the study, in order to&#xD;
      decrease attrition rates, and to blind participants to the intervention. The balance&#xD;
      exercises, although not improving bone health, could decrease the risk of fracture, making&#xD;
      the sham control group more ethical, owing to potential improvements, and limited risks.&#xD;
&#xD;
      To ensure quality control, digitised video clips of all exercises will be provided for the&#xD;
      participants, who will be encouraged to perform the exercises as demonstrated on the video.&#xD;
      The participants will be invited to one fully supervised group exercise session per month.&#xD;
      These sessions will be used to monitor exercise quality, and to ensure progression is&#xD;
      appropriate for each participant. Sessions will last 15-20 min. Attendance at these sessions&#xD;
      will be monitored through registers. Apart from these supervised exercise sessions,&#xD;
      participants will be given free choice to determine where and when they do the exercises. At&#xD;
      the instructor-led session, training logs will be submitted. If they are unable to attend,&#xD;
      participants will be asked to submit training logs electronically, or via post. To encourage&#xD;
      adherence, an App will be used, which will enable weekly announcements to be posted, as well&#xD;
      as emails and/or text reminders. Participants will be free to contact the researchers about&#xD;
      any concerns they have during the intervention. Apart from the exercise undertaken,&#xD;
      participants will be requested to maintain their usual exercise throughout the study.&#xD;
&#xD;
      To improve adherence, Bandura's Social Cognitive Theory for changing behaviour will be drawn&#xD;
      upon. Specific constructs will include the knowledge and skills to perform the prescribed&#xD;
      intervention, personal regulation of goal-directed health behaviour (self-control), and&#xD;
      self-confidence in engaging in the exercise despite the absence of supervision.&#xD;
      Reinforcement, i.e., activities that increase the propensity for adherence during the trial&#xD;
      and beyond the study's lifespan, will also be addressed.&#xD;
&#xD;
      Participants' level of self-efficacy for engaging in lifestyle change will be assessed using&#xD;
      a five-point Likert scale, from 'not at all confident' to 'very confident'. Participants will&#xD;
      be asked to rate how confident they are to commit to engage in the exercise, irrespective of&#xD;
      usual circumstances such as time constraints, stress, and fatigue. Assessment of&#xD;
      self-efficacy will take place at the study onset, and at one-monthly intervals (via&#xD;
      attendance at the supervised group sessions). With non-attendance, assessment will take place&#xD;
      electronically. In the event of a low rating, modes of handling such situations without&#xD;
      compromising commitment to the regime, will be given in relation to each participant's&#xD;
      personal circumstances. In addition, at the study outset, participants will be asked to&#xD;
      identify any circumstances that could motivate them to comply with the exercise, as well as&#xD;
      any perceived barriers to adherence. Any issues will be discussed, and participants will be&#xD;
      given the opportunity to design personalised adherence strategies. The aim will be to foster&#xD;
      self-efficacy in both groups.&#xD;
&#xD;
      After the eight-month intervention, all females in the trial arm, who have completed the&#xD;
      study, will be invited to take part in a focus group (in groups of 8, depending on numbers&#xD;
      who volunteer for this), to examine participants' perceptions of the intervention. A topic&#xD;
      guide will be used, which includes: An exploration of the perceived barriers to undertaking&#xD;
      the exercise intervention; issues with adherence; acceptability of the intervention; adverse&#xD;
      events; enjoyment; ratings of perceived exertion; how easily the intervention could be&#xD;
      incorporated into lifestyle. At the end of the focus group, the topic guide will be checked&#xD;
      to ensure that all areas had been covered. Focus groups will likely last between 45 and 60&#xD;
      min, although will continue until the researcher feels that data saturation has been reached.&#xD;
      The focus groups will be audio-recorded and subsequently transcribed to facilitate analysis.&#xD;
      Non-verbal participant behaviour will also be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Assessed for feasibility&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">December 20, 2020</completion_date>
  <primary_completion_date type="Actual">December 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The project will be a randomised controlled trial, investigating between and within group differences pre- and post-intervention. There will be two trial arms: an intervention group and sham control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will be blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Broadband ultrasound attenuation</measure>
    <time_frame>8 months</time_frame>
    <description>BUA as measured by Quantitative Ultrasound (UBIS 5000 Diagnostic Medical Systems, Montpellier, France).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed up-and-go test</measure>
    <time_frame>8 months</time_frame>
    <description>The test involves the participant starting in a seated position, walking 3 m, turning around, then walking back to the chair to sit down</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ground reaction force</measure>
    <time_frame>8 months</time_frame>
    <description>To estimate the mechanical loading force due to the exercise, ground reaction force will be evaluated with the aid of a force plate (Advanced Mechanical Technology, Inc., AMTI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jump height</measure>
    <time_frame>8 months</time_frame>
    <description>A countermovement jump test (with arms swinging naturally) will be used to assess change in jump height, using the Optojump system (Microgate S.r.l., Bolzano, Italy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on quality of life</measure>
    <time_frame>8 months</time_frame>
    <description>Quality of life using the Short-Form Health Survey, version 2; scoring from 0-100, with higher meaning better health</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Osteoporosis, Postmenopausal</condition>
  <arm_group>
    <arm_group_label>Jumping exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 rest-inserted jumps performed three times per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balance exercise</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Single-leg balances for 60 seconds on each leg</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Jumping exercise</intervention_name>
    <description>Participants will be required to perform 10 maximal vertical jumps, with a 10-s rest interval between each jump, using an arm swing in countermovement style on three days per week. The jumps will be performed without shoes on a hard surface. The jumps will be preceded by a warm-up lasting approximately 3 min and consisting of mobilisation exercises for the legs and lower back. Jumping will be progressed over time and in accordance with individual needs.</description>
    <arm_group_label>Jumping exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance exercise (sham control)</intervention_name>
    <description>Participants will be required to perform balance exercises. Participants will be required to balance on one leg for up to 60 seconds (2 x 60 s is equivalent in duration to the 10 jumps). This exercise will be progressed.</description>
    <arm_group_label>Balance exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postmenopausal; aged ≥50 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers will be excluded from the study if they: are using any medicated that may&#xD;
             affect bone turnover (e.g., corticosteroids, anticonvulsants, anticoagulants,&#xD;
             calcitonin, bisphosphonates, raloxifene, denosumab and/or anabolic agents such as&#xD;
             parathyroid hormone and growth hormone or steroids), including hormone replacement&#xD;
             therapy and hormone-based contraception, within 6 months of starting the study; have&#xD;
             or have had any bone, metabolic, kidney, liver, thyroid, gastro-intestinal or hormonal&#xD;
             disorders or cancer, that may affect bone turnover; have a close family history of&#xD;
             osteoporosis; have sustained a low trauma fragility fracture in the past 6 months; are&#xD;
             a heavy smoking (&gt;20 cigarettes/day); if they are already undertaking bone-specific&#xD;
             jumping exercises or equivalent exercises; if they have an existing knee, hip or back&#xD;
             injury or have any medical condition that would prevent them from completing the&#xD;
             exercise. Additional exclusions at baseline testing will include: a low BUA score,&#xD;
             i.e., estimated T score of &lt;2.5; obesity as determined by body mass index of &gt;35&#xD;
             km/m2, to minimise risk of strain or injury associated with the exercise. Participants&#xD;
             will also not be able to undertake the bone scan if they have any foot swelling, as&#xD;
             this can make results difficult to interpret.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Staffordshire University</name>
      <address>
        <city>Stoke</city>
        <state>England</state>
        <zip>ST4 2DF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>March 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Staffordshire University</investigator_affiliation>
    <investigator_full_name>Jacky Forsyth</investigator_full_name>
    <investigator_title>Associate Professor of Exercise Physiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</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/NCT04469374
org study id: StaffsUni1
nct id: NCT04469374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: to examine the effect of an exercise intervention for preventing osteoporosis among
      postmenopausal women.

      Objectives:

      To examine whether mean values for Broadband Ultrasound Attenuation (BUA) using Quantitative
      Ultrasound (QUS) among postmenopausal women following an eight-month exercise intervention
      (and at 3-month follow up), will be significantly higher than those obtained
      pre-intervention.

      To examine whether mean BUA values among postmenopausal women following an eight-month
      exercise intervention (and at 3-month follow up) will be significantly higher than mean
      values obtained from participants in a control group undertaking sham exercises for an
      equivalent duration.

      To examine the feasibility of the eight-month exercise intervention for a potential larger
      study (larger sample size, increased number of trial arms and increased outcome measures), in
      terms of recruitment, adherence, perceptions, barriers, and acceptability.
Data will be collected at baseline, on study completion and at 3-month follow-up. Sequel to
      baseline data collection and ascertainment of eligibility, participants will be randomised
      into either the exercise intervention group or sham-control group. Randomisation will be
      through computer-generation of random numbers. Participants will be blinded to group
      allocation. Both groups will complete their required programme for eight months.

      For the intervention group, participants will be required to perform 10 maximal vertical
      jumps, with a 10-s rest interval between each jump, using an arm swing in countermovement
      style on three days per week. The jumps will be performed without shoes on a hard surface.
      The jumps will be preceded by a warm-up lasting approximately 3 min and consisting of
      mobilisation exercises for the legs and lower back. Jumping will be progressed over time and
      in accordance with individual needs. Initially, jumping may be undertaken with the use of a
      handheld support (such as the back of a chair or table), should participants feel unstable.
      Jumps will be progressed to include multi-directional movements (jumping to the side,
      forwards, backwards, and diagonally). Natural progression will also occur as participants
      should improve their jump height with increased muscular explosiveness. Participants will be
      asked to fill out a simple, daily training log, stipulating when they have undertaken the
      exercise, in order for adherence to be assessed.

      In the control group, participants will be required to perform balance exercises. The
      balancing exercises will be progressed and varied (to ensure adherence). Initially, the use
      of a handheld support (such as the back of the chair) can be used. Participants will be
      required to balance on one leg for up to 60 seconds (2 x 60 s is equivalent in duration to
      the 10 jumps). This exercise will initially be progressed using time, and then by doing the
      following: confounding the visual fixation (e.g., head turns), changing the centre of mass
      (e.g. arm/leg lifts); performing the stork balance (hands on hips, knee bent and supported by
      standing leg); reaching in multiple directions before regaining the initial stance; closing
      the eyes; reducing the base of support; and a combination of these activities. The starting
      level of difficulty will be prescribed by the researcher, according to each participant's
      functional ability. The balance exercises will be preceded by a warm-up lasting approximately
      3 min and consisting of mobilisation exercises for the legs and lower back. The purpose of
      the sham exercise is to foster the perception of full participation in the study, in order to
      decrease attrition rates, and to blind participants to the intervention. The balance
      exercises, although not improving bone health, could decrease the risk of fracture, making
      the sham control group more ethical, owing to potential improvements, and limited risks.

      To ensure quality control, digitised video clips of all exercises will be provided for the
      participants, who will be encouraged to perform the exercises as demonstrated on the video.
      The participants will be invited to one fully supervised group exercise session per month.
      These sessions will be used to monitor exercise quality, and to ensure progression is
      appropriate for each participant. Sessions will last 15-20 min. Attendance at these sessions
      will be monitored through registers. Apart from these supervised exercise sessions,
      participants will be given free choice to determine where and when they do the exercises. At
      the instructor-led session, training logs will be submitted. If they are unable to attend,
      participants will be asked to submit training logs electronically, or via post. To encourage
      adherence, an App will be used, which will enable weekly announcements to be posted, as well
      as emails and/or text reminders. Participants will be free to contact the researchers about
      any concerns they have during the intervention. Apart from the exercise undertaken,
      participants will be requested to maintain their usual exercise throughout the study.

      To improve adherence, Bandura's Social Cognitive Theory for changing behaviour will be drawn
      upon. Specific constructs will include the knowledge and skills to perform the prescribed
      intervention, personal regulation of goal-directed health behaviour (self-control), and
      self-confidence in engaging in the exercise despite the absence of supervision.
      Reinforcement, i.e., activities that increase the propensity for adherence during the trial
      and beyond the study's lifespan, will also be addressed.

      Participants' level of self-efficacy for engaging in lifestyle change will be assessed using
      a five-point Likert scale, from 'not at all confident' to 'very confident'. Participants will
      be asked to rate how confident they are to commit to engage in the exercise, irrespective of
      usual circumstances such as time constraints, stress, and fatigue. Assessment of
      self-efficacy will take place at the study onset, and at one-monthly intervals (via
      attendance at the supervised group sessions). With non-attendance, assessment will take place
      electronically. In the event of a low rating, modes of handling such situations without
      compromising commitment to the regime, will be given in relation to each participant's
      personal circumstances. In addition, at the study outset, participants will be asked to
      identify any circumstances that could motivate them to comply with the exercise, as well as
      any perceived barriers to adherence. Any issues will be discussed, and participants will be
      given the opportunity to design personalised adherence strategies. The aim will be to foster
      self-efficacy in both groups.

      After the eight-month intervention, all females in the trial arm, who have completed the
      study, will be invited to take part in a focus group (in groups of 8, depending on numbers
      who volunteer for this), to examine participants' perceptions of the intervention. A topic
      guide will be used, which includes: An exploration of the perceived barriers to undertaking
      the exercise intervention; issues with adherence; acceptability of the intervention; adverse
      events; enjoyment; ratings of perceived exertion; how easily the intervention could be
      incorporated into lifestyle. At the end of the focus group, the topic guide will be checked
      to ensure that all areas had been covered. Focus groups will likely last between 45 and 60
      min, although will continue until the researcher feels that data saturation has been reached.
      The focus groups will be audio-recorded and subsequently transcribed to facilitate analysis.
      Non-verbal participant behaviour will also be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The project will be a randomised controlled trial, investigating between and within group differences pre- and post-intervention. There will be two trial arms: an intervention group and sham control group.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will be blinded to group allocation.
measure: Broadband ultrasound attenuation
time frame: 8 months
description: BUA as measured by Quantitative Ultrasound (UBIS 5000 Diagnostic Medical Systems, Montpellier, France).
measure: Timed up-and-go test
time frame: 8 months
description: The test involves the participant starting in a seated position, walking 3 m, turning around, then walking back to the chair to sit down
measure: Ground reaction force
time frame: 8 months
description: To estimate the mechanical loading force due to the exercise, ground reaction force will be evaluated with the aid of a force plate (Advanced Mechanical Technology, Inc., AMTI).
measure: Jump height
time frame: 8 months
description: A countermovement jump test (with arms swinging naturally) will be used to assess change in jump height, using the Optojump system (Microgate S.r.l., Bolzano, Italy).
measure: Questionnaire on quality of life
time frame: 8 months
description: Quality of life using the Short-Form Health Survey, version 2; scoring from 0-100, with higher meaning better health
arm group label: Jumping exercise
arm group type: Experimental
description: 10 rest-inserted jumps performed three times per week
arm group label: Balance exercise
arm group type: Sham Comparator
description: Single-leg balances for 60 seconds on each leg
intervention type: Other
intervention name: Jumping exercise
description: Participants will be required to perform 10 maximal vertical jumps, with a 10-s rest interval between each jump, using an arm swing in countermovement style on three days per week. The jumps will be performed without shoes on a hard surface. The jumps will be preceded by a warm-up lasting approximately 3 min and consisting of mobilisation exercises for the legs and lower back. Jumping will be progressed over time and in accordance with individual needs.
arm group label: Jumping exercise
intervention type: Other
intervention name: Balance exercise (sham control)
description: Participants will be required to perform balance exercises. Participants will be required to balance on one leg for up to 60 seconds (2 x 60 s is equivalent in duration to the 10 jumps). This exercise will be progressed.
arm group label: Balance exercise
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Staffordshire University
investigator full name: Jacky Forsyth
investigator title: Associate Professor of Exercise Physiology
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
sharing ipd: No