Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health
- Conditions
- Physical Disability
- Interventions
- Behavioral: Intensity-controlled physical activity training (IPAT)Behavioral: Education and Access (EA)
- Registration Number
- NCT06013046
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The goal of the study is to improve cardiometabolic health outcomes for wheelchair users and identify strategies for achieving sufficient physical activity intensity during bouts of structured physical activity.
- Detailed Description
Wheelchair users have a higher risk for obesity and cardiometabolic health-related diseases compared to persons without a disability and remain one of the most sedentary populations in the United States. Engaging wheelchair users in physical activity levels following the current recommendations to achieve cardiometabolic health-related changes requires tailoring and supports in an accessible community environment, but it is unclear if a community-based physical activity intervention that also prioritizes intensity levels is best to improve cardiometabolic health. This project will determine the effects and implementation outcomes of a community-based, intensity-controlled aerobic and strength training intervention on the cardiometabolic health of wheelchair users and will significantly advance public health knowledge of how to engage wheelchair uses in physical activity to reverse or prevent cardiometabolic health-related disease.
The aims of the study are to:
1. Compare the effectiveness of the intensity-controlled physical activity training (IPAT) group to the education and access (EA) group for improving cardiometabolic-related health outcomes.
2. Identify barriers and facilitators to wheelchair users engaging in physical activity at a community-based accessible gym.
3. Examine the moderators (i.e., age, race, gender, duration of disability, wheelchair type, and physical function) and mediators (ie., self-efficacy, motivation, and barriers/facilitators) of the proposed intervention to understand for whom and how the intervention was effective.
A hybrid I RCT will be conducted. One hundred and ten individuals with a physical disability requiring the use of a wheelchair will be recruited. Each participant will be randomized into either a 14-week IPAT group (n=56) or a 14-week EA group (n=54). Participants' cardiomrespiratory, body composition, metabolic blood chemistries and strength will be assessed baseline (T1) and post intervention (T2).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Age 18 years or older
- Has a physical disability requiring the use of a wheelchair (includes manual wheelchairs, motorized wheelchairs, motor-assisted wheelchairs, and electric scooters)
- Community-dwelling
- Ability to independently move one or both upper extremities
- Has participated in no more than 60 minutes of moderate-intensity physical activity per week in the past month
- English-speaking
- Able to provide informed consent
- Willing to participate in two assessments and 40 intervention sessions
- Determination by their physician to be medically unstable
- Has had cardiovascular complications within the past year or unstable heart disease
- Currently receiving medical treatment for an acute injury
- Presence of a stage IV pressure injury
- Currently pregnant or suspect pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensity-controlled physical activity training (IPAT) Intensity-controlled physical activity training (IPAT) A group provided education on physical activity recommendations for people with disabilities, access to a community-based accessible gym, and an intensity-controlled 14-week one-on-one supervised physical activity training intervention. Education and Access (EA) Education and Access (EA) A group provided education on physical activity recommendations for people with disabilities and access to a community-based accessible gym in order to independently complete a 14-week physical activity program.
- Primary Outcome Measures
Name Time Method VO2max - Cardiorespiratory Fitness change (Max Oxygen Consumption Change in ml/kg/min) Baseline and up to 3 weeks post intervention VO2max will be measured in ml/kg/min using a portable, breath-by-breath metabolic system with an optoelectronic reader, as well as reliable highly linear and rapid response O2 and CO2 sensors (COSMED K5, COSMED: The Metabolic Company, Chicago, IL). This testing will be completed while the participant performs a graded-exercise test on a crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp-up protocol which is typically completed in 8-12 minutes, and a subsequent 5-minute recovery phase.
- Secondary Outcome Measures
Name Time Method DEXA - Body Composition Overall Body Fat Change (kg) Baseline and up to 3 weeks post intervention Participants will undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety.
DEXA - Body Composition Overall Lean Mass Change (kg) Baseline and up to 3 weeks post intervention Participants will undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety.
Metabolic blood chemistries (fasting glucose and insulin) - Insulin Resistance Change (mg/dL) Baseline and up to 3 weeks post intervention Participants will fast 8-10 hours prior to blood draw. Blood draws will be completed to determine both fasting glucose and fasting insulin. These results will then be used to figure the HOMA-IR score, which is an insulin resistance score in mg/dL .
Brachial artery reactivity test (BART) - Endothelial function change (%) Baseline and up to 3 weeks post intervention Participants will undergo a BART via ultrasound. The test will measure flow-mediated dilation and endothelium independent dilation of the brachial artery using a high-resolution transducer on the Vivid E95, E9, Vivid IQ (portable) or Vivid I (portable) systems. Brachial artery flow-mediated vasodilation correlates with measures of coronary artery endothelial function and can predict future adverse coronary events.
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States