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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mobility Limitation
• Intervention / Treatment: Behavioral: On the Move group exercise

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 Type: Interventional
• Enrollment (Actual): 529
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence - Content	We have identified the essential components of OTM. Inclusion of essential components will be determined from exercise class logs. OTM instructors will be required to keep a log of time spent on each program component in each class, for each of the 24 classes. We will review the logs and determine if the essential components (warm-up, walking, stepping patterns, strengthening exercises and cool-down) are included in each of the classes. For each of the classes offered, instructors will be classified as being fully adherent, adherent to core components only, or non-adherent.	Throughout the 12 week intervention
Adherence - Dose of exposure classes offered	Dose of exposure classes offered will be quantified as number of classes offered by the community center (0-24). Each community center is required to document when exercise classes are offered. The investigators will obtain this information directly from the community center records. A greater number of classes is better.	Throughout the 12 week intervention
Adherence - Dose of exposure, weeks of exercise	Dose of exposure, weeks of exercise will be quantified as the number of weeks the exercise classes are offered (0-12). Each community center is required to document when exercise classes are offered. The investigators will obtain this information directly from the community center records. A greater number of weeks is better.	Throughout the 12 week intervention
Adherence - Dose of exposure, participant level.	Dose of exposure at the participant level will be quantified as the number of classes each participant attends, 0-24. The instructor will keep a class log of each session to record attendance. A greater number of classes is better.	Throughout the 12 week intervention
Competence - Quality of delivery	The content experts will use a standardized checklist to document if the instructor is delivering the program with adequate skill. The checklist includes 20 items such as appropriately demonstrating exercises, modifying the exercises as needed, and progressing exercises appropriately. Competence will be quantified by the total number of items present on the checklist; scores will range from 0-20.	Throughout the 12 week intervention
Adaptations	Adaptations will be recorded, defined and classified using the Framework for Reporting Adaptations and Modifications-Expanded (FRAME).	Throughout the 12 week intervention.

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jennifer S Brach, PhD, PT, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): September 18, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mobility Limitation
• Other Study ID Numbers: STUDY21070206; R01AG071520 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data sets will be available at the time the primary paper is accepted for publication or at 2 years after the last participant is followed whichever comes first.
• IPD Sharing Access Criteria: Data will be available by secure transfer to investigators who complete a data sharing agreement for data from this project. The sharable data will be archived at the study's home site and will be available for sharing by submitting a request to the PI. Once a request is approved by the PI and the requester agrees to the conditions for data use, the data will be transferred.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No