Testing the Implementation of Movement-to-Music in a Community Fitness Center and Blended Onsite and Teleexercise Class

NCT ID: NCT03991273

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2021-04-20

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]).

Conditions

Exercise; Disability Physical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Y-M2M©

a group-based M2M© program conducted onsite at a local YMCA

Group Type: EXPERIMENTAL

Y-M2M©

Intervention Type: OTHER

The Y-M2M© group will receive classes that will be delivered onsite at a YMCA facility. Movement-to-Music (M2M©) is an instructor-guided exercise program that is coupled with music to enhance strength, cardiorespiratory capacity, range of motion, and balance.

B-M2M©

a blended program that provides Y-M2M© and a home-based M2M© via videoconferencing

Group Type: EXPERIMENTAL

Y-M2M©

Intervention Type: OTHER

The Y-M2M© group will receive classes that will be delivered onsite at a YMCA facility. Movement-to-Music (M2M©) is an instructor-guided exercise program that is coupled with music to enhance strength, cardiorespiratory capacity, range of motion, and balance.

B-M2M©

Intervention Type: OTHER

The B-M2M© group will receive the same onsite M2M© classes as the Y-M2M© group, but they will also be provided with the option of performing home-based M2M© that will be delivered via videoconferencing.

Interventions

Y-M2M©

The Y-M2M© group will receive classes that will be delivered onsite at a YMCA facility. Movement-to-Music (M2M©) is an instructor-guided exercise program that is coupled with music to enhance strength, cardiorespiratory capacity, range of motion, and balance.

Intervention Type: OTHER

B-M2M©

The B-M2M© group will receive the same onsite M2M© classes as the Y-M2M© group, but they will also be provided with the option of performing home-based M2M© that will be delivered via videoconferencing.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lakeshore Foundation

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Byron Lai

Project Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James H Rimmer, PhD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Hui-Ju Young, PhD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Byron W Lai, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

90DPGE0005-01-00

Identifier Type: -

Identifier Source: org_study_id