Clinical trial NCT05126355: Effectiveness of the On the Move Group Exercise Program to Improve Mobility in Community-dwelling Older Adults
Official title: Effectiveness of the On the Move Group Exercise Program to Improve Mobility in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mobility Limitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-11-19
Enrollment: 502
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait speed
timeFrame: 12 weeks
measure: Gait speed
timeFrame: 24 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) mobility
timeFrame: 12 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) mobility
timeFrame: 24 weeks
measure: Participant Satisfaction
timeFrame: immediately post intervention
Other outcomes:
measure: Adherence - Content
timeFrame: Throughout the 12 week intervention
measure: Adherence - Dose of exposure classes offered
timeFrame: Throughout the 12 week intervention
measure: Adherence - Dose of exposure, weeks of exercise
timeFrame: Throughout the 12 week intervention
measure: Adherence - Dose of exposure, participant level.
timeFrame: Throughout the 12 week intervention
measure: Competence - Quality of delivery
timeFrame: Throughout the 12 week intervention
measure: Adaptations
timeFrame: Throughout the 12 week intervention.
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jennifer S Brach, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: