Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health (WATCH)

The Washington University

Status: Enrolling

Conditions: Physical Disability

Treatments: Behavioral: Education and Access (EA); Behavioral: Intensity-controlled physical activity training (IPAT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06013046

202209017

R01HD111022 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups, including a placebo group

Intensity-controlled physical activity training (IPAT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Intensity-controlled physical activity training (IPAT)

Education and Access (EA)

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Education and Access (EA)