Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health

Official title

Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health (WATCH): A Community-based Randomized Control Trial

Overview

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=54) or a 14-week EA group (n=54). Participants' cardiorespiratory, body composition, metabolic blood chemistries and strength will be assessed baseline (T1) and post intervention (T2).

Interventions

• Behavioral Intensity-controlled physical activity training (IPAT)
  The IPAT group will receive 40 (90 minute) one-on-one, intensity-controlled, exercise sessions by trained staff over 14 weeks. The initial 2-week period will include dedicated education on topics including physical activity guidelines and the benefits of achieving them, the feeling of moderate-to-vigorous physical activity intensity levels, and the appropriate exercises for achieving desired intensity levels. Tailored sessions will be created for each participant based on their physical fitness,
• Behavioral Education and Access (EA)
  The EA group will receive an initial 60 minute educational session, during which they will receive information on the adapted exercise equipment in the Orthwein Center, education on the physical activity guidelines and the health benefits of achieving them, and access to the Orthwein Center accessible gym. They will then complete a 14-week independent workout program with the goal of meeting physical activities guidelines. They will have access to Orthwein Center staff to help with minimal setup

Primary outcome measures

• VO2max - Cardiorespiratory Fitness change (Max Oxygen Consumption Change in ml/kg/min) [Time frame: Baseline and up to 3 weeks post intervention]

Secondary outcome measures (4)

• DEXA - Body Composition Overall Body Fat Change (kg) [Time frame: Baseline and up to 3 weeks post intervention]
• DEXA - Body Composition Overall Lean Mass Change (kg) [Time frame: Baseline and up to 3 weeks post intervention]
• Metabolic blood chemistries (fasting glucose and insulin) - Insulin Resistance Change (mg/dL) [Time frame: Baseline and up to 3 weeks post intervention]
• Brachial artery reactivity test (BART) - Endothelial function change (%) [Time frame: Baseline and up to 3 weeks post intervention]

Eligibility criteria

Inclusion criteria

• 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)
• Ability to attend weekly exercise sessions in person
• 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
• Ability to complete a valid V02max score with 2 attempts

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Washington University School of Medicine — St Louis

Identifiers

NCT: NCT06013046 · 202209017 · R01HD111022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗