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

NCT03991273 | Withdrawn

• 1 other identifier: 90DPGE0005-01-00
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exercise; Disability Physical

Keywords

disability; disabilities; teleexercise; movement-to-music; physical activity

Outcome Measures

Primary Outcomes (10)

• 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)

• Phase 2: Quantitative feasibility metric (Process outcome #1:Enrollment Rate)

  Enrollment rate: the number of participants screened / total enrolled

  Intervention (weeks 1-12)

• 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)

• Phase 2: Quantitative feasibility metric (Process outcome #3: Attrition Rate)

  Attrition rate: number of participants that withdraw from the intervention

  Intervention (weeks 1-12)

• 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)

• 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)

• 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)

• 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)

• Phase 2: Quantitative feasibility metric (Management outcome #2: Issues with data management)

  Issues with data management: frequency of issues encountered

  Intervention (weeks 1-12)

• 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 Outcomes (11)

• Phase 2: Quantitative feasibility metric (Scientific outcome #1: Physical Activity)

  Intervention (weeks 1 and 12)

• Phase 2: Quantitative feasibility metric (Scientific outcome #2: Quality of life)

  Intervention (weeks 1 and 12)

• Phase 2: Quantitative feasibility metric (Scientific outcome #3: Social participation)

  Intervention (weeks 1 and 12)

• Phase 2: Quantitative feasibility metric (Scientific outcome # 4: Self-Efficacy)

  Intervention (weeks 1 and 12)

• Phase 2: Quantitative feasibility metric (Scientific outcome # 5: Outcome expectations)

  Intervention (weeks 1 and 12)

Study Arms (2)

Y-M2M©

EXPERIMENTAL

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

Other: Y-M2M©

B-M2M©

EXPERIMENTAL

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

Other: Y-M2M©; Other: B-M2M©

Interventions

Y-M2M© 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©; Y-M2M©

B-M2M© 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.

B-M2M©

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• between the ages of 19 to 70 yrs.;
• physician clearance to participate;
• willing to participate in an exercise program 3 times per week;
• conversant in and reads English.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Lakeshore Foundation: collaborator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• James H Rimmer, PhD

  University of Alabama at Birmingham

  STUDY CHAIR

• Hui-Ju Young, PhD

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Byron W Lai, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Coordinator

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 19, 2019
• Study Start: April 20, 2021
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be uploaded within 12 months of completing the study.
• Access Criteria: Free downloads via the Internet