Recruiting

Physical Activity

Sponsor:

Washington University School of Medicine

Code:

NCT06013046

Conditions

Physical Disability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensity-controlled physical activity training (IPAT)

Education and Access (EA)

Study Details

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

Study ID

NCT06013046

Start date

Aug 10, 2023

Status verified date

Jan, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: 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.

Interventions

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, 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.

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 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kimberly A Walker, OTD

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

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Kimberly A Walker, OTD

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

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Occupational Therapy
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-01-29.