Physical Activity Training for Wheelchair Users

(WATCH Trial)

Recruiting at 2 trial locations

Overseen By Kerri A Morgan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Unstable heart disease, Acute injury, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help wheelchair users improve heart and metabolism health by identifying the best exercise methods. Participants will either join a 14-week supervised exercise program, known as Intensity-controlled Physical Activity Training (IPAT), or receive resources to exercise independently at an accessible gym, referred to as Education and Access (EA). It suits wheelchair users who have been exercising less than an hour of moderate activity per week and can move at least one arm independently. As an unphased trial, this study provides a unique opportunity for participants to explore effective exercise strategies tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this physical activity training is safe for wheelchair users?

Research has shown that intensity-controlled physical activity training (IPAT) is generally manageable for wheelchair users. In past studies, participants completed the exercise program with only minor side effects, indicating it doesn't cause significant harm or discomfort.

Another study on high-intensity interval training (HIIT) for wheelchair users found the exercises safe. Participants handled the physical demands without major problems.

Overall, these findings suggest that structured physical activity training like IPAT is safe for wheelchair users. It is designed to be effective without causing significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers new ways to help wheelchair users stay active. The Intensity-controlled Physical Activity Training (IPAT) is distinctive because it combines personalized, supervised workouts with access to an accessible gym, making it more structured than typical self-guided exercise programs. Meanwhile, the Education and Access (EA) component empowers individuals by providing them with the knowledge and resources to develop their own exercise routines. Together, these approaches aim to enhance physical activity levels and overall health for wheelchair users, which could lead to improved quality of life and greater independence.

What evidence suggests that this trial's treatments could be effective for improving cardiometabolic health in wheelchair users?

Research shows that intensity-controlled physical activity training (IPAT), which participants in this trial may receive, can benefit people who use wheelchairs. Studies have found that more intense exercise can improve heart health and help manage weight and blood sugar levels. Many wheelchair users often lead less active lifestyles, increasing their risk of heart disease and other health issues. Structured and supervised exercise can reduce these risks, promoting more active habits and better overall health. The IPAT approach aims to make exercise both effective and manageable for people with physical disabilities. Another group in this trial will receive education and access to a community-based accessible gym to independently complete a 14-week physical activity program. ^{1 2 3 6 7}

Who Is on the Research Team?

Kerri A Morgan, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who use wheelchairs due to physical disabilities, can consent, speak English, and are able to move at least one arm. Participants should live in the community and not be very active currently—doing less than an hour of moderate exercise a week.

Inclusion Criteria

Willing to participate in two assessments and 40 intervention sessions

Community-dwelling

Able to provide informed consent

Exclusion Criteria

I have a severe, deep skin wound.

Determination by their physician to be medically unstable

I am currently being treated for a recent injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 14-week physical activity intervention, either intensity-controlled or independent, to improve cardiometabolic health

14 weeks

Follow-up

Participants are monitored for changes in cardiometabolic health outcomes, including VO2max, body composition, and metabolic blood chemistries

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Education and Access (EA)
• Intensity-controlled physical activity training (IPAT)

Trial Overview The study tests two methods: 'Education and Access' which provides information and resources, and 'Intensity-controlled physical activity training' where participants do exercises designed to improve heart health while managing how hard they work out.

How Is the Trial Designed?

Group I: Intensity-controlled physical activity training (IPAT) Active Control 1 Intervention

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.

Group II: Education and Access (EA) Placebo Group 1 Intervention

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 Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

The Activ8 Activity Monitors effectively distinguish between independent wheelchair propulsion and non-propulsive activities, achieving an overall agreement of 82.1% in a study with 16 participants performing various tasks.

However, the monitors struggled to accurately classify five different levels of wheelchair-related activities, with only 56.6% overall agreement, indicating that improvements are needed for more detailed activity recognition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of consumer-grade activity monitor to identify manual wheelchair propulsion in standardized activities of daily living. Leving, MT., Horemans, HLD., Vegter, RJK., et al.[2022]

A 6-week interval-training program on a wheelchair ergometer significantly improved work capacity in spinal cord-injured participants, with maximal tolerated power increasing by 19.6% and peak oxygen consumption (VO2) rising by 16%.

Participants also showed enhanced endurance, with improvements in power output and ventilation at ventilatory threshold, while heart rate and ventilation decreased at the same work rate, indicating better cardiovascular efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a wheelchair ergometer training programme on spinal cord-injured persons. Bougenot, MP., Tordi, N., Betik, AC., et al.[2022]

Participants in the high-intensity interval training (HIIT) group increased their moderate-to-vigorous physical activity (MVPA) by 53 minutes over 24 weeks, significantly more than the 19 minutes increase seen in the moderate-intensity continuous training (MICT) group, indicating better adherence to HIIT.

Both HIIT and MICT improved cardiorespiratory fitness (V̇O2peak), with HIIT showing a greater increase, suggesting that HIIT can be an effective and maintainable exercise option for individuals at high risk of type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval or Continuous Moderate Exercise: A 24-Week Pilot Trial. Locke, SR., Bourne, JE., Beauchamp, MR., et al.[2019]

In a study of 128 inactive wheelchair users over 12 months, those receiving staff-supported exercise interventions reported about 17 more minutes of exercise per week compared to those in the self-guided group, indicating that more intensive support can enhance exercise adoption.

Despite the staff-supported group exercising more frequently, there were no significant differences in aerobic capacity or strength between the two groups, suggesting that while support helps with exercise frequency, additional strategies may be needed to improve overall fitness levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for everyone: a randomized controlled trial of project workout on wheels in promoting exercise among wheelchair users. Froehlich-Grobe, K., Lee, J., Aaronson, L., et al.[2021]

This systematic review analyzed 14 studies on physical activity interventions for community-dwelling wheelchair users, finding that most reported improvements in physical activity levels and cardiovascular disease outcomes.

The review highlights the need for larger studies with follow-ups and community participatory research to better evaluate the effectiveness of these interventions in improving health outcomes for wheelchair users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity programs for cardiovascular outcomes in community wheelchair users: A systematic review. Andrabi, MS., Mumba, M., Key, B., et al.[2022]

A study involving 11 manual wheelchair users found that both high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) were feasible and safe for home-based exercise, with no severe adverse events reported.

While neither training program significantly improved cardiorespiratory fitness or upper limb strength, participants in both groups reported moderate to significant subjective improvements, indicating potential benefits of these training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Safety, and Preliminary Effectiveness of a Home-Based Self-Managed High-Intensity Interval Training Program Offered to Long-Term Manual Wheelchair Users. Gauthier, C., Brosseau, R., Hicks, AL., et al.[2022]

Brief exercise training (ET) counseling is shown to be an efficient and cost-effective method to increase physical activity (PA) among patients, leading to significant health benefits across various disease groups.

To fully integrate exercise as a vital part of healthcare, a fundamental shift is needed in how healthcare systems view and implement ET counseling, treating it with the same importance as pharmaceuticals and other medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity promotion in the health care system. Vuori, IM., Lavie, CJ., Blair, SN.[2022]

Physical training for patients with internal diseases must be tailored to their specific conditions, such as monitoring heart rate for cardiac patients and managing blood pressure for hypertensive patients, to ensure safety and effectiveness.

In conditions like diabetes and mental health issues, proper training combined with diet and psychological support can significantly improve health outcomes, highlighting the importance of a comprehensive rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Training program for rehabilitation of patients with internal diseases]. Apor, P.[2016]

The Internet-based physical activity support program (IPAS) did not show significant improvements in moderate-to-vigorous physical activity (MVPA) or secondary outcomes among 137 cancer survivors compared to a control group after 6 months.

Blended care, which included physiotherapist telephone counseling, received better satisfaction scores than online-only support, but overall adherence to the program was low, indicating a need for improved accessibility and support in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of and Lessons Learned from an Internet-Based Physical Activity Support Program (with and without Physiotherapist Telephone Counselling) on Physical Activity Levels of Breast and Prostate Cancer Survivors: The PABLO Randomized Controlled Trial. van de Wiel, HJ., Stuiver, MM., May, AM., et al.[2021]

A 5-week interval training program using a wheelchair ergometer significantly improved cardiorespiratory responses in able-bodied women, indicating potential benefits for wheelchair-dependent individuals.

Participants in the exercise training group showed lower heart rates, pulmonary ventilation, and oxygen uptake during exercise after the training, while the sedentary control group did not experience these improvements, suggesting that interval training can enhance fitness and performance in wheelchair users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise program for wheelchair activity. Glaser, RM., Sawka, MN., Durbin, RJ., et al.[2006]

A study involving 60 youth using manual wheelchairs showed that combining wheelchair mobility skills (WMS) training with exercise training significantly improved physical activity, WMS, and confidence in wheelchair mobility over a total intervention period of 24 weeks.

The training led to notable enhancements in both aerobic and anaerobic performance, although it did not affect cardiorespiratory fitness, highlighting the importance of this combined approach in rehabilitation for youth with mobility challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of wheelchair mobility skills and exercise training on physical activity, fitness, skills and confidence in youth using a manual wheelchair. Sol, ME., Verschuren, O., Horemans, H., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC0D17598B8961CAA4A01A2FFCEB861BF/project-details/11031386

Wheelchair user physical activity training ... - NIH RePORTER The current study proposes a hybrid I randomized controlled trial to test the cardiometabolic effects of a tailored intensity-controlled physical activity ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03727893

Exercise Training and Manual Wheelchair Users With SCI Participating in exercise protocols of higher intensity may offer a more effective and time-efficient method of increasing cardiovascular fitness and metabolic ...

3. withpower.com withpower.com/trial/phase-disabilities-physical-7-2023-c7c28

Physical Activity Training for Wheelchair Users (WATCH Trial) ... Intensity-controlled physical activity training (IPAT) will have tolerable side effects & efficacy for patients with Physical Disabilities. See if you qualify

4. reporter.nih.gov reporter.nih.gov/search/15EFCE08498BC2D67598B8961CAA4A01A2FFCEB861BF/project-details/11037937

Project Details Confirmatory analyses have revealed that wheelchair users live predominantly sedentary lifestyles and have substantially higher cardiometabolic risk factors ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714411002795

An exercise trial for wheelchair users: Project workout on ... This study will provide evidence regarding the effectiveness of a multi-component behaviorally based intervention for promoting exercise adoption among people ...

6. biotechhunter.com biotechhunter.com/trials/NCT06013046

Wheelchair User Physical Activity Training Intervention ... 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 ...

7. researchprotocols.org researchprotocols.org/2025/1/e57423

Cardiometabolic Health Intervention Using Music and ... This study's design is a parallel-arm randomized controlled trial enrolling 132 physically inactive adult wheelchair users with poor cardiometabolic profiles.