Osteoporosis, PostmenopausalMOBILENCT04469374
Menopause Osteoporosis and Bone Intervention Using Lifestyle Exercise.
A study testing Jumping exercise in people with Osteoporosis, Postmenopausal, run by Staffordshire University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Jumping exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal; aged ≥50 years
Who cannot join
- Volunteers will be excluded from the study if they: are using any medicated that may affect bone turnover (e.g., corticosteroids, anticonvulsants, anticoagulants, calcitonin, bisphosphonates, raloxifene, denosumab and/or anabolic agents such as parathyroid hormone and growth hormone or steroids), including hormone replacement therapy and hormone-based contraception, within 6 months of starting the study; have or have had any bone, metabolic, kidney, liver, thyroid, gastro-intestinal or hormonal disorders or cancer, that may affect bone turnover; have a close family history of osteoporosis; have sustained a low trauma fragility fracture in the past 6 months; are a heavy smoking (>20 cigarettes/day); if they are already undertaking bone-specific jumping exercises or equivalent exercises; if they have an existing knee, hip or back injury or have any medical condition that would prevent them from completing the exercise. Additional exclusions at baseline testing will include: a low BUA score, i.e., estimated T score of <2.5; obesity as determined by body mass index of >35 km/m2, to minimise risk of strain or injury associated with the exercise. Participants will also not be able to undertake the bone scan if they have any foot swelling, as this can make results difficult to interpret.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an Exercise Intervention for Preventing Osteoporosis Among Postmenopausal Women
Aim: to examine the effect of an exercise intervention for preventing osteoporosis among postmenopausal women.
Objectives:
Read more
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.
Read the detailed description
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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Jumping exercise, Balance exercise (sham control)
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jumping exerciseOther
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.
Balance exercise (sham control)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Jumping exercise | Experimental | 10 rest-inserted jumps performed three times per week Receives: Other: Jumping exercise |
| Balance exercise | Sham comparator | Single-leg balances for 60 seconds on each leg Receives: Other: Balance exercise (sham control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Broadband ultrasound attenuation
BUA as measured by Quantitative Ultrasound (UBIS 5000 Diagnostic Medical Systems, Montpellier, France).
Measured: 8 months
Secondary outcomes (4)
Timed up-and-go test
The test involves the participant starting in a seated position, walking 3 m, turning around, then walking back to the chair to sit down
Measured: 8 months
Ground reaction force
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).
Measured: 8 months
Jump height
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).
Measured: 8 months
Questionnaire on quality of life
Quality of life using the Short-Form Health Survey, version 2; scoring from 0-100, with higher meaning better health
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Dec 2019
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Why it stopped: Assessed for feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staffordshire University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacky Forsyth, Staffordshire University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469374
- Sponsor's protocol ID
- StaffsUni1
- Acronym
- MOBILE
- Status last verified
- Oct 2022
- First submitted
- 25 Mar 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Exercise Intervention for Preventing Osteoporosis Among Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04469374
- Acronym / sponsor ID
- MOBILE / StaffsUni1
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Assessed for feasibility
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Staffordshire UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Jumping exercise | Experimental | Other: Jumping exercise10 rest-inserted jumps performed three times per week |
| Balance exercise | Sham comparator | Other: Balance exercise (sham control)Single-leg balances for 60 seconds on each leg |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- postmenopausal; aged ≥50 years
Key exclusion criteria (1 listed)
- Volunteers will be excluded from the study if they: are using any medicated that may affect bone turnover (e.g., corticosteroids, anticonvulsants, anticoagulants, calcitonin, bisphosphonates, raloxifene, denosumab and/or anabolic agents such as parathyroid hormone and growth hormone or steroids), including hormone replacement therapy and hormone-based contraception, within 6 months of starting the study; have or have had any bone, metabolic, kidney, liver, thyroid, gastro-intestinal or hormonal disorders or cancer, that may affect bone turnover; have a close family history of osteoporosis; have sustained a low trauma fragility fracture in the past 6 months; are a heavy smoking (>20 cigarettes/day); if they are already undertaking bone-specific jumping exercises or equivalent exercises; if they have an existing knee, hip or back injury or have any medical condition that would prevent them from completing the exercise. Additional exclusions at baseline testing will include: a low BUA score, i.e., estimated T score of <2.5; obesity as determined by body mass index of >35 km/m2, to minimise risk of strain or injury associated with the exercise. Participants will also not be able to undertake the bone scan if they have any foot swelling, as this can make results difficult to interpret.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jumping exerciseParticipants 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. | Other | Jumping exercise |
| Balance exercise (sham control)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. | Other | Balance exercise |
Primary outcome
Broadband ultrasound attenuation
Time frame: 8 months
BUA as measured by Quantitative Ultrasound (UBIS 5000 Diagnostic Medical Systems, Montpellier, France).
4 secondary outcomes
Timed up-and-go test
Time frame: 8 months
Ground reaction force
Time frame: 8 months
Jump height
Time frame: 8 months
Questionnaire on quality of life
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Assessed for feasibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jumping exercise in people with Osteoporosis, Postmenopausal, run by Staffordshire University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Assessed for feasibility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Broadband ultrasound attenuation (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.