NCT05126355

Brief 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 intervention fidelity.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
529

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jun 2022Aug 2026

First Submitted

Initial submission to the registry

November 1, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

June 23, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

November 1, 2021

Last Update Submit

November 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Patient-Reported Outcomes Measurement Information System (PROMIS) mobility

    12 weeks

  • Patient-Reported Outcomes Measurement Information System (PROMIS) mobility

    24 weeks

  • Participant Satisfaction

    immediately post intervention

Other Outcomes (6)

  • Adherence - Content

    Throughout the 12 week intervention

  • Adherence - Dose of exposure classes offered

    Throughout the 12 week intervention

  • Adherence - Dose of exposure, weeks of exercise

    Throughout the 12 week intervention

  • +3 more other outcomes

Study Arms (2)

On the Move

EXPERIMENTAL

On the Move group exercise program to improve walking. Delivered twice per week for 12 weeks.

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.

Behavioral: On the Move group exercise

Interventions

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.

On the MoveOn the Move - Delayed

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • attend the senior center
  • can ambulate household distances independently
  • can participate in group exercise classes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer S Brach, PhD, PT

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Dean for Faculty Affairs and Development

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 19, 2021

Study Start

June 23, 2022

Primary Completion

September 18, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.
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.

Locations