Clinical trial NCT03991273: Testing the Implementation of Movement-to-Music in a Community Fitness Center and Blended Onsite and Teleexercise Class
Official title: Testing the Implementation Efficacy of Movement-to-Music Delivered in a Community-Based Fitness Center and Blended Onsite and Home-based Group Teleexercise Class: A Mixed-Methods Pilot Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise
Disability Physical
Keywords: disability
disabilities
teleexercise
movement-to-music
physical activity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Lakeshore Foundation
First posted: 2019-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To prepare for a large scale-up study, the goal of this pilot implementation trial is to examine the feasibility of Movement-to-Music (M2M©) delivery mechanisms through two channels: 1) a group-based M2M© program conducted onsite at a local YMCA; and 2) a blended program that provides Y-M2M© and a home-based M2M© (B-M2M©) via videoconferencing. A key element of this pilot is to examine issues associated with participant-provider interactions, and to better understand the robustness of the technology to deliver a group-based (teleexercise) version of M2M© in the home setting.

Detailed description: There will be 4 phases to this study. In phase 1, the investigators will explore potential barriers and supports that may affect the delivery of M2M© at one YMCA facility through one-on-one interviews with YMCA staff that have been trained to conduct M2M©.

Phase 2 will include a quantitative monitoring phase. During this phase the 2 delivery mechanisms of M2M© (Y-M2M© and B-M2M©) will be evaluated through assessments of quantitative feasibility metrics before, during, and after the intervention. The intervention will include a convenient sample of 54 participants.

To expand on the findings from the previous quantitative phase, phase 3 will include post-intervention focus group interviews conducted separately for each stakeholder group: all 54 participants, M2M© trainers, research assistants involved with technical support, and YMCA staff that were involved with the project.

During phase 4 (the integrative phase), the researchers will compile the quantitative and qualitative findings for the three primary feasibility metrics (process, resource, and management). These findings will then be comprehensively analyzed by a review panel that will provide suggestions for improvement within each metric. The panel will then discuss the summative findings and vote towards acceptable or not acceptable feasibility.

The 12-week Y-M2M© intervention will be pilot tested at one YMCA facility in Birmingham, AL.The B-M2M© group will be provided with the flexibility of attending the same onsite classes at the YMCA facility as participants in the Y-M2M© group and will also be able to participate in group M2M© teleexercise classes at home that are conducted through Internet video conferencing.

The investigators will use a permuted block randomization design to ensure close balance between the arms across waves and to increase the unpredictability in the upcoming assignment and prevent inadvertent bias. The project statistician will generate the randomization list that will be provided to the project coordinator in sealed envelopes to conceal the allocation. Assessors (health and function assessments done at Lakeshore Foundation) will be blinded to participant assignment and allocation of the arm assignment will not be done until baseline testing and measures are collected.

Primary quantitative outcomes will include those related to process, resources, and management. In summary, these metrics will include measures of adherence, issues that arise with implementation and the efficiency to which they are resolved, and intervention fidelity between the delivery sites. Secondary quantitative outcomes will include estimates of variability in scientific outcomes (physical activity; quality of life; social participation; fitness Measures (cardiorespiratory fitness, muscle strength, lower extremity function; social cognitive theory constructs \[Self-efficacy, Outcome expectations, Barriers, Social support\]).

Eligibility criteria: Inclusion Criteria:

1. primary diagnosis of head injury, stroke, MS, spinal cord injury, spina bifida, Parkinson's disease or cerebral palsy conferred by a physician and fits one of the three functional mobility groups (Groups I-III);
2. between the ages of 19 to 70 yrs.;
3. physician clearance to participate;
4. willing to participate in an exercise program 3 times per week;
5. conversant in and reads English.

Exclusion Criteria:

1. participated in a similar intervention in the last 6 months;
2. use of tobacco products in the last 6 months;
3. cognitive impairment;
4. active pressure ulcer;
5. any contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines;
6. visual acuity that prevents following a group exercise class;
7. significant hearing impairment impeding ability to hear music to engage in exercise.

Primary outcomes:
measure: Phase 1: Foreseeable implementation barriers and supports as reported by YMCA trainers
timeFrame: Pre-intervention (week 0)
measure: Phase 2: Quantitative feasibility metric (Process outcome #1:Enrollment Rate)
timeFrame: Intervention (weeks 1-12)
measure: Phase 2: Quantitative feasibility metric (Process outcome #2: Class Attendance)
timeFrame: Intervention (weeks 1-12)
measure: Phase 2: Quantitative feasibility metric (Process outcome #3: Attrition Rate)
timeFrame: Intervention (weeks 1-12)
measure: Phase 2: Quantitative feasibility metric (Process outcome #4: Time to complete data collection)
timeFrame: Intervention (weeks 1-12)
measure: Phase 2: Quantitative feasibility metric (Process outcome #1: Technical difficulties with technology)
timeFrame: Intervention (weeks 1-12)
measure: Phase 2: Quantitative feasibility metric (Resource outcome #2: Resources required by the YMCA)
timeFrame: Intervention (weeks 1-12)
measure: Phase 2: Quantitative feasibility metric (Management outcome #1: M2M fidelity between conditions)
timeFrame: Intervention (weeks 1-12)
measure: Phase 2: Quantitative feasibility metric (Management outcome #2: Issues with data management)
timeFrame: Intervention (weeks 1-12)
measure: Phase 3: Qualitative interview exploring stakeholders' perceptions of intervention implementation
timeFrame: Post-Intervention (week 13)
Secondary outcomes:
measure: Phase 2: Quantitative feasibility metric (Scientific outcome #1: Physical Activity)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome #2: Quality of life)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome #3: Social participation)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 4: Self-Efficacy)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 5: Outcome expectations)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 6: Barriers)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 7: Social support)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 8: Cardiorespiratory fitness)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 9: Hand-grip strength)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 10: Lower extremity function)
timeFrame: Intervention (weeks 1 and 12)
measure: Phase 2: Quantitative feasibility metric (Scientific outcome # 11: Lower extremity function)
timeFrame: Intervention (weeks 1 and 12)
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: James H Rimmer, PhD
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham
name: Hui-Ju Young, PhD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Byron W Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References: