Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health

NCT06013046 | Recruiting

• 2 other identifiers: 202209017R01HD111022
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Disability

Keywords

Occupational Therapy; Exercise

Outcome Measures

Primary Outcomes (1)

• VO2max - Cardiorespiratory Fitness change (Max Oxygen Consumption Change in ml/kg/min)

  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.

  Baseline and up to 3 weeks post intervention

Secondary Outcomes (4)

• DEXA - Body Composition Overall Body Fat Change (kg)

  Baseline and up to 3 weeks post intervention

• DEXA - Body Composition Overall Lean Mass Change (kg)

  Baseline and up to 3 weeks post intervention

• Metabolic blood chemistries (fasting glucose and insulin) - Insulin Resistance Change (mg/dL)

  Baseline and up to 3 weeks post intervention

• Brachial artery reactivity test (BART) - Endothelial function change (%)

  Baseline and up to 3 weeks post intervention

Other Outcomes (2)

• PROMIS - Change in Pain Intensity (Short Form 3a)

  Baseline and up to 3 weeks post intervention

• PROMIS - Change in Fatigue (Short Form 8a)

  Baseline and up to 3 weeks post intervention

Study Arms (2)

Intensity-controlled physical activity training (IPAT)

ACTIVE COMPARATOR

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.

Behavioral: Intensity-controlled physical activity training (IPAT)

Education and Access (EA)

PLACEBO COMPARATOR

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.

Behavioral: Education and Access (EA)

Interventions

Intensity-controlled physical activity training (IPAT) BEHAVIORAL

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, goals, preferred exercise equipment and results from their baseline assessment. Each session can include vitals, pain assessment, warm-up, aerobic training, strength exercises and a cool-down. The participants will be monitored to ensure they are achieving at least 150 minutes of moderate-to-vigorous intensity physical activity weekly. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. The overall goal is to improve cardiorespiratory fitness.

Intensity-controlled physical activity training (IPAT)

Education and Access (EA) BEHAVIORAL

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 and guidance, but sessions will be self-directed. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. Participants will be asked to complete a log for each session to report pain, details of the activities they completed during their workout, the RPE for each activity, and how long each activity lasted.

Education and Access (EA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Kerri A Morgan, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly A Walker, OTD

CONTACT

314-273-7010; walker.k@wustl.edu

Kerri A Morgan, PhD

CONTACT

314-286-1659; morgank@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy and Neurology

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: August 28, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)