Effectiveness of the On the Move Group Exercise Program to Improve Mobility in Community-dwelling Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of the On the Move Group Exercise Program to Improve Mobility in Community-dwelling Older Adults

Conditions
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Mobility Limitation

Intervention / Treatment
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* Behavioral: On the Move group exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 years of age or older attend the senior center can ambulate household distances independently can participate in group exercise classes Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On the Move<br>On the Move group exercise program to improve walking. Delivered twice per week for 12 weeks. | Behavioral: On the Move group exercise<br>* 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.<br>|
| Other: On the Move - Delayed<br>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. | Behavioral: On the Move group exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | immediately post intervention |