Clinical trial NCT06013046: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Disability
Keywords: Occupational Therapy
Exercise
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)
* 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

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

Primary outcomes:
measure: VO2max - Cardiorespiratory Fitness change (Max Oxygen Consumption Change in ml/kg/min)
timeFrame: Baseline and up to 3 weeks post intervention
Secondary outcomes:
measure: DEXA - Body Composition Overall Body Fat Change (kg)
timeFrame: Baseline and up to 3 weeks post intervention
measure: DEXA - Body Composition Overall Lean Mass Change (kg)
timeFrame: Baseline and up to 3 weeks post intervention
measure: Metabolic blood chemistries (fasting glucose and insulin) - Insulin Resistance Change (mg/dL)
timeFrame: Baseline and up to 3 weeks post intervention
measure: Brachial artery reactivity test (BART) - Endothelial function change (%)
timeFrame: Baseline and up to 3 weeks post intervention
Other outcomes:
measure: PROMIS - Change in Pain Intensity (Short Form 3a)
timeFrame: Baseline and up to 3 weeks post intervention
measure: PROMIS - Change in Fatigue (Short Form 8a)
timeFrame: Baseline and up to 3 weeks post intervention
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kerri A Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
References: