Physical DisabilityWATCHNCT06013046
Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health
A study testing Education and Access (EA) in people with Physical Disability, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Disability
- What is being tested?
- Education and Access (EA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
Kimberly A Walker, OTD, 314-273-7010, walker.k@wustl.edu
Kerri A Morgan, PhD, 314-286-1659, morgank@wustl.edu
About this study
Official title: Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health (WATCH): A Community-based Randomized Control Trial
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.
Read the 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:
- 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.
- Identify barriers and facilitators to wheelchair users engaging in physical activity at a community-based accessible gym.
- 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).
- Conditions
- Physical Disability
- Being tested
- Intensity-controlled physical activity training (IPAT), Education and Access (EA)
- Keywords
- Occupational Therapy, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-controlled physical activity training (IPAT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education and Access (EA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 3 weeks post intervention
Secondary outcomes (4)
DEXA - Body Composition Overall Body Fat Change (kg)
Participants will undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety.
Measured: Baseline and up to 3 weeks post intervention
DEXA - Body Composition Overall Lean Mass Change (kg)
Participants will undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety.
Measured: Baseline and up to 3 weeks post intervention
Metabolic blood chemistries (fasting glucose and insulin) - Insulin Resistance Change (mg/dL)
Participants will fast 8-10 hours prior to blood draw. Blood draws will be completed to determine both fasting glucose and fasting insulin. These results will then be used to figure the HOMA-IR score, which is an insulin resistance score in mg/dL .
Measured: Baseline and up to 3 weeks post intervention
Brachial artery reactivity test (BART) - Endothelial function change (%)
Participants will undergo a BART via ultrasound. The test will measure flow-mediated dilation and endothelium independent dilation of the brachial artery using a high-resolution transducer on the Vivid E95, E9, Vivid IQ (portable) or Vivid I (portable) systems. Brachial artery flow-mediated vasodilation correlates with measures of coronary artery endothelial function and can predict future adverse coronary events.
Measured: Baseline and up to 3 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start10 Aug 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kerri Morgan, Washington University School of Medicine
- Investigators
- Kerri A Morgan, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013046
- Sponsor's protocol ID
- 202209017
- Other IDs
- R01HD111022
- Acronym
- WATCH
- Status last verified
- Jan 2026
- First submitted
- 2 Jun 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health (WATCH): A Community-based Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06013046
- Acronym / sponsor ID
- WATCH / 202209017
- Conditions
- Physical Disability
- Keywords
- Occupational Therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Identify barriers and facilitators to wheelchair users engaging in physical activity at a community-based accessible gym.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensity-controlled physical activity training (IPAT) | Active comparator | Behavioral: 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. |
| Education and Access (EA) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intensity-controlled physical activity training (IPAT) |
| 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. | Behavioural | Education and Access (EA) |
Primary outcome
VO2max - Cardiorespiratory Fitness change (Max Oxygen Consumption Change in ml/kg/min)
Time frame: Baseline and up to 3 weeks post intervention
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerri A Morgan, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Access (EA) in people with Physical Disability, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly A Walker, OTD (314-273-7010, walker.k@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.