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

Exercise Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03991273
• Other study ID #: 90DPGE0005-01-00
• Status: Withdrawn
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: April 20, 2021

Study information

• Verified date: April 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disability Physical
• Exercise

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Lakeshore Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Foreseeable implementation barriers and supports as reported by YMCA trainers	Prior to conducting the intervention, the investigators will conduct interviews to qualitatively explore YMCA trainers' perceptions of organizational or system factors that can potentially facilitate the adoption of M2M© in YMCAs and tailor the M2M© delivery plan accordingly (using open-ended questions).	Pre-intervention (week 0)
Primary	Phase 2: Quantitative feasibility metric (Process outcome #1:Enrollment Rate)	Enrollment rate: the number of participants screened / total enrolled	Intervention (weeks 1-12)
Primary	Phase 2: Quantitative feasibility metric (Process outcome #2: Class Attendance)	Attendance to the exercise sessions: total number of sessions attended divided by the total 36 prescribed sessions	Intervention (weeks 1-12)
Primary	Phase 2: Quantitative feasibility metric (Process outcome #3: Attrition Rate)	Attrition rate: number of participants that withdraw from the intervention	Intervention (weeks 1-12)
Primary	Phase 2: Quantitative feasibility metric (Process outcome #4: Time to complete data collection)	Time to complete data collection: time in minutes required to complete data collection (average of both pre- and post-data collection visit times)	Intervention (weeks 1-12)
Primary	Phase 2: Quantitative feasibility metric (Process outcome #1: Technical difficulties with technology)	Technical difficulties with technology: Frequency of issues experienced by participants and trainers	Intervention (weeks 1-12)
Primary	Phase 2: Quantitative feasibility metric (Resource outcome #2: Resources required by the YMCA)	Resources required by the YMCA: # of items purchased for a YMCA M2M class	Intervention (weeks 1-12)
Primary	Phase 2: Quantitative feasibility metric (Management outcome #1: M2M fidelity between conditions)	M2M fidelity between conditions: the frequency of times a deviation from the protocol was observed for both the YMCA and Teleexercise classes.	Intervention (weeks 1-12)
Primary	Phase 2: Quantitative feasibility metric (Management outcome #2: Issues with data management)	Issues with data management: frequency of issues encountered	Intervention (weeks 1-12)
Primary	Phase 3: Qualitative interview exploring stakeholders' perceptions of intervention implementation	Focus group interviews will be 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. The semi-structured interviews will explore participants' perceptions regarding the intervention implementation process, resources, and management (using open-ended questions)	Post-Intervention (week 13)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome #1: Physical Activity)	Physical Activity: measured via the Godin Leisure-Time Exercise Questionnaire (total score and health-contribution score)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome #2: Quality of life)	Quality of life: measured via the NIH PROMIS 10 Global Health Items (total score)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome #3: Social participation)	Social participation: measured via the NIH PROMIS Ability to Participate in Social Roles and Activities	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 4: Self-Efficacy)	Self-Efficacy: measured via the Exercise Self-Efficacy Scale (total score)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 5: Outcome expectations)	Outcome expectations: measured via the Multidimensional Outcomes Expectations for Exercise Scale (total score)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 6: Barriers)	Barriers to physical activity: measured via the Barriers in Physical Activity Questionnaire (total score)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 7: Social support)	Social support: measured via the Social Provision Scale (total score)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 8: Cardiorespiratory fitness)	Cardiorespiratory fitness: peak oxygen consumption (ml.kg-1.min-1)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 9: Hand-grip strength)	Cardiorespiratory fitness: peak hand-grip strength (Newtons; both hands)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 10: Lower extremity function)	Lower extremity function: measured via the Short Physical Performance Battery (total score)	Intervention (weeks 1 and 12)
Secondary	Phase 2: Quantitative feasibility metric (Scientific outcome # 11: Lower extremity function)	Lower extremity function: measured via the Timed Up and Go (total score)	Intervention (weeks 1 and 12)