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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Phase 2: Quantitative feasibility metric (Process outcome #4: Time to complete data collection)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Phase 2: Quantitative feasibility metric (Process outcome #4: Time to complete data collection)
时间窗: Intervention (weeks 1-12)
Time to complete data collection: time in minutes required to complete data collection (average of both pre- and post-data collection visit times)
Phase 2: Quantitative feasibility metric (Process outcome #1: Technical difficulties with technology)
时间窗: Intervention (weeks 1-12)
Technical difficulties with technology: Frequency of issues experienced by participants and trainers
Phase 2: Quantitative feasibility metric (Management outcome #2: Issues with data management)
时间窗: Intervention (weeks 1-12)
Issues with data management: frequency of issues encountered
Phase 3: Qualitative interview exploring stakeholders' perceptions of intervention implementation
时间窗: Post-Intervention (week 13)
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)
Phase 2: Quantitative feasibility metric (Process outcome #3: Attrition Rate)
时间窗: Intervention (weeks 1-12)
Attrition rate: number of participants that withdraw from the intervention
Phase 1: Foreseeable implementation barriers and supports as reported by YMCA trainers
时间窗: Pre-intervention (week 0)
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).
Phase 2: Quantitative feasibility metric (Process outcome #2: Class Attendance)
时间窗: Intervention (weeks 1-12)
Attendance to the exercise sessions: total number of sessions attended divided by the total 36 prescribed sessions
Phase 2: Quantitative feasibility metric (Process outcome #1:Enrollment Rate)
时间窗: Intervention (weeks 1-12)
Enrollment rate: the number of participants screened / total enrolled
Phase 2: Quantitative feasibility metric (Resource outcome #2: Resources required by the YMCA)
时间窗: Intervention (weeks 1-12)
Resources required by the YMCA: # of items purchased for a YMCA M2M class
Phase 2: Quantitative feasibility metric (Management outcome #1: M2M fidelity between conditions)
时间窗: Intervention (weeks 1-12)
M2M fidelity between conditions: the frequency of times a deviation from the protocol was observed for both the YMCA and Teleexercise classes.
次要结局
- Phase 2: Quantitative feasibility metric (Scientific outcome #2: Quality of life)(Intervention (weeks 1 and 12))
- Phase 2: Quantitative feasibility metric (Scientific outcome # 5: Outcome expectations)(Intervention (weeks 1 and 12))
- Phase 2: Quantitative feasibility metric (Scientific outcome # 7: Social support)(Intervention (weeks 1 and 12))
- Phase 2: Quantitative feasibility metric (Scientific outcome # 10: Lower extremity function)(Intervention (weeks 1 and 12))
- Phase 2: Quantitative feasibility metric (Scientific outcome #1: Physical Activity)(Intervention (weeks 1 and 12))
- Phase 2: Quantitative feasibility metric (Scientific outcome # 8: Cardiorespiratory fitness)(Intervention (weeks 1 and 12))
- Phase 2: Quantitative feasibility metric (Scientific outcome # 9: Hand-grip strength)(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 # 6: Barriers)(Intervention (weeks 1 and 12))
- Phase 2: Quantitative feasibility metric (Scientific outcome # 11: Lower extremity function)(Intervention (weeks 1 and 12))
研究者
Byron Lai
Project Coordinator
University of Alabama at Birmingham
