Mobility LimitationNCT05126355
Effectiveness of the On the Move Group Exercise Program to Improve Mobility in Community-dwelling Older Adults
A study testing On the Move group exercise in people with Mobility Limitation, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of On the Move (OTM) in terms of improving mobility among 502 older adults in 44 senior community centers and to evaluate intervention fidelity, including adherence and competence, and the impact of organizational, instructor, and participant level factors on… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- On the Move group exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age or older
- attend the senior center
- can ambulate household distances independently
- can participate in group exercise classes
Who cannot join
- impaired cognition (unable to understand consent process)
- plans to leave the area for an extended period of time
- any acute or unstable illness or medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
The purpose of this study is to test the effectiveness of On the Move (OTM) in terms of improving mobility among 502 older adults in 44 senior community centers and to evaluate intervention fidelity, including adherence and competence, and the impact of organizational, instructor, and participant level factors on intervention fidelity.
Read the detailed description
The investigators will conduct a Hybrid I trial, blending effectiveness and implementation research aims to: test the effectiveness of OTM, evaluate intervention fidelity, and determine the extent intervention fidelity moderates intervention effectiveness. The investigators will evaluate the effects of OTM taught by community instructors for improving mobility among 502 older adults in 44 community centers using a cluster randomized design with a delayed intervention control arm. Intervention fidelity will be assessed by instructor self-report (intervention diaries) and observation (fidelity checklist). Organizational, instructor, and participant level factors which may impact fidelity will be assessed via standard instruments, focus groups and interviews.
Specific Aims are as follows:
Aim 1: Establish the effectiveness of OTM on improvements in walking ability and post-intervention persistence of benefits.
Rationale: OTM delivered by research staff is effective. Establishing the effectiveness of OTM delivered by community instructors is necessary before wide-scale implementation.
Hypothesis: Compared to a randomized control group followed for 12 weeks, the OTM group will have greater gains in gait speed (primary outcome) and self-reported mobility at 12 and 24 weeks of follow-up.
Aim 2: Assess intervention fidelity (measures of adherence and competence) and identify the impact of organizational, instructor, and participant level factors on intervention fidelity.
Rationale: To inform future implementation efforts, it is critical to measure intervention fidelity and to identify factors associated with fidelity.
Hypothesis: Organizational, instructor, and participant level factors will impact fidelity. For example, instructors who utilize greater facilitation strategies will have higher fidelity, poor organizational acceptance of the program will be related to lower fidelity, and fewer organizational resources will lead to lower fidelity.
Aim 3: Determine the extent to which intervention fidelity, measured by adherence and competence, moderates the effectiveness of OTM.
Rationale: Intervention fidelity may influence the effectiveness of OTM. Understanding the consequences of differing levels of intervention fidelity on effectiveness will inform future implementation efforts.
Hypothesis: Higher fidelity will be associated with greater mobility gains, and there may be critical fidelity thresholds.
- Conditions
- Mobility Limitation
- Being tested
- On the Move group exercise
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On the Move group exerciseBehavioural
The OTM exercise program is a group-based program led by a certified OTM instructor. The frequency and duration of OTM is 50 minutes, twice weekly for 12 weeks for a total of 24 classes. The OTM exercise program is based on principles of motor learning that enhance smooth and automatic movement control. The program contains a warm-up (5 minutes), stepping patterns (15 minutes), walking patterns (15 minutes), strengthening exercises (10 minutes), and cool-down exercises (5 minutes). The warm-up and cool down contain gentle range of motion exercises and stretches for the lower extremities and trunk. Considered essential components, the stepping and walking patterns are progressively more difficult, goal-oriented patterns that promote the timing and coordination of stepping integrated with the phases of the gait cycle.
| Study group | Role | What they receive |
|---|---|---|
| On the Move | Experimental | On the Move group exercise program to improve walking. Delivered twice per week for 12 weeks. Receives: Behavioral: On the Move group exercise |
| On the Move - Delayed | Other | Individuals in this arm will be placed on a wait-list for 12 weeks and will receive no intervention during this time. At the end of the 12 weeks they will receive the On the Move group exercise program. This is a wait-list control group. Receives: Behavioral: On the Move group exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
The time it take the subject to walk 4 meters and their usual walking speed. Recorded as m/s. Faster speeds indicate better mobility.
Measured: 12 weeks
Gait speed
The time it take the subject to walk 4 meters and their usual walking speed. Recorded as m/s. Faster speeds indicate better mobility.
Measured: 24 weeks
Secondary outcomes (3)
Patient-Reported Outcomes Measurement Information System (PROMIS) mobility
The Patient-Reported Outcomes Measurement Information System - mobility measure is 15 item scale to assess self-reported perceptions of mobility. A single mobility score is obtained from the short form, with higher scores indicating better mobility.
Measured: 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) mobility
The Patient-Reported Outcomes Measurement Information System - mobility measure is 15 item scale to assess self-reported perceptions of mobility. A single mobility score is obtained from the short form, with higher scores indicating better mobility.
Measured: 24 weeks
Participant Satisfaction
Participant satisfaction will be assessed using a survey that includes five items measured on a Likert scale and three yes/no questions. The Likert items assess degree of satisfaction with various components of the exercise program (i.e. the exercises, instructor, music, space, and the overall program). The yes/no questions assess if the program met the participants' expectations, if they feel they benefited from the program, and if they would recommend the program to others.
Measured: immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start23 Jun 2022
- Primary completion18 Sep 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jennifer S. Brach, University of Pittsburgh
- Investigators
- Jennifer S Brach, PhD, PT, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126355
- Sponsor's protocol ID
- STUDY21070206
- Other IDs
- R01AG071520
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2021
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data may be shared. Because the human subjects included in the project could potentially be identified, given the relatively limited geographic distribution of these subjects, investigators requesting data will be required to sign a data sharing agreement. For external requests, the agreement will be executed through the University's Office of Research; and for internal requests, through email.
Publications
Brach JS, VanSwearingen JM, Freburger J, Weiner BJ, Zanardelli JJ, Perera S. On the Move in the community: Protocol for a hybrid 1 trial examining effectiveness and fidelity of a community-based group exercise program for older adults. Contemp Clin Trials. 2024 Oct;145:107666. doi: 10.1016/j.cct.2024.107666. Epub 2024 Aug 17.
PubMed 39159805
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the On the Move Group Exercise Program to Improve Mobility in Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT05126355
- Acronym / sponsor ID
- STUDY21070206
- Conditions
- Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 529 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Nov 2021 (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.
The purpose of this study is to test the effectiveness of On the Move (OTM) in terms of improving mobility among 502 older adults in 44 senior community centers and to evaluate intervention fidelity, including adherence and competence, and the impact of organizational, instructor, and participant level factors on intervention fidelity.
Detailed description
The investigators will conduct a Hybrid I trial, blending effectiveness and implementation research aims to: test the effectiveness of OTM, evaluate intervention fidelity, and determine the extent intervention fidelity moderates intervention effectiveness. The investigators will evaluate the effects of OTM taught by community instructors for improving mobility among 502 older adults in 44 community centers using a cluster randomized design with a delayed intervention control arm. Intervention fidelity will be assessed by instructor self-report (intervention diaries) and observation (fidelity checklist). Organizational, instructor, and participant level factors which may impact fidelity will be assessed via standard instruments, focus groups and interviews.
Specific Aims are as follows:
Aim 1: Establish the effectiveness of OTM on improvements in walking ability and post-intervention persistence of benefits.
Rationale: OTM delivered by research staff is effective. Establishing the effectiveness of OTM delivered by community instructors is necessary before wide-scale implementation.
Hypothesis: Compared to a randomized control group followed for 12 weeks, the OTM group will have greater gains in gait speed (primary outcome) and self-reported mobility at 12 and 24 weeks of follow-up.
Aim 2: Assess intervention fidelity (measures of adherence and competence) and identify the impact of organizational, instructor, and participant level factors on intervention fidelity.
Rationale: To inform future implementation efforts, it is critical to measure intervention fidelity and to identify factors associated with fidelity.
Hypothesis: Organizational, instructor, and participant level factors will impact fidelity. For example, instructors who utilize greater facilitation strategies will have higher fidelity, poor organizational acceptance of the program will be related to lower fidelity, and fewer organizational resources will lead to lower fidelity.
Aim 3: Determine the extent to which intervention fidelity, measured by adherence and competence, moderates the effectiveness of OTM.
Rationale: Intervention fidelity may influence the effectiveness of OTM. Understanding the consequences of differing levels of intervention fidelity on effectiveness will inform future implementation efforts.
Hypothesis: Higher fidelity will be associated with greater mobility gains, and there may be critical fidelity thresholds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On the Move | Experimental | Behavioral: On the Move group exerciseOn the Move group exercise program to improve walking. Delivered twice per week for 12 weeks. |
| On the Move - Delayed | Other | Behavioral: On the Move group exerciseIndividuals in this arm will be placed on a wait-list for 12 weeks and will receive no intervention during this time. At the end of the 12 weeks they will receive the On the Move group exercise program. This is a wait-list control group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years of age or older
- attend the senior center
- can ambulate household distances independently
- can participate in group exercise classes
Key exclusion criteria (3 listed)
- impaired cognition (unable to understand consent process)
- plans to leave the area for an extended period of time
- any acute or unstable illness or medical condition
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 |
|---|---|---|
| On the Move group exerciseThe OTM exercise program is a group-based program led by a certified OTM instructor. The frequency and duration of OTM is 50 minutes, twice weekly for 12 weeks for a total of 24 classes. The OTM exercise program is based on principles of motor learning that enhance smooth and automatic movement control. The program contains a warm-up (5 minutes), stepping patterns (15 minutes), walking patterns (15 minutes), strengthening exercises (10 minutes), and cool-down exercises (5 minutes). The warm-up and cool down contain gentle range of motion exercises and stretches for the lower extremities and trunk. Considered essential components, the stepping and walking patterns are progressively more difficult, goal-oriented patterns that promote the timing and coordination of stepping integrated with the phases of the gait cycle. | Behavioural | On the Move, On the Move - Delayed |
Primary outcome
Gait speed
Time frame: 12 weeks
The time it take the subject to walk 4 meters and their usual walking speed. Recorded as m/s. Faster speeds indicate better mobility.
Gait speed
Time frame: 24 weeks
The time it take the subject to walk 4 meters and their usual walking speed. Recorded as m/s. Faster speeds indicate better mobility.
3 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) mobility
Time frame: 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) mobility
Time frame: 24 weeks
Participant Satisfaction
Time frame: immediately post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Derived from this study: PubMed 39159805Brach JS, VanSwearingen JM, Freburger J, Weiner BJ, Zanardelli JJ, Perera S. On the Move in the community: Protocol for a hybrid 1 trial examining effectiveness and fidelity of a community-based group exercise program for older adults. Contemp Clin Trials. 2024 Oct;145:107666. doi: 10.1016/j.cct.2024.107666. Epub 2024 Aug 17.
- Individual participant dataSharing planned: Yes. All collected individual participant data may be shared. Because the human subjects included in the project could potentially be identified, given the relatively limited geographic distribution of these subjects, investigators requesting data will be required to sign a data sharing agreement. For external requests, the agreement will be executed through the University's Office of Research; and for internal requests, through email.
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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.
Jennifer S Brach, PhD, PT principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On the Move group exercise in people with Mobility Limitation, run by University of Pittsburgh at 1 site in United States.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. 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 States. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gait speed (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05126355, which also lists 1 linked publication.
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 6 Nov 2025.