ExergamingParaCycleNCT07189546
Development of a Socially Connected Exercise System for Wheelchair Users
An observational study of Exergaming, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Physical activity (PA) levels among Veterans who use wheelchairs is very low despite the importance of PA in improving overall physical and mental health. Wheelchair users face many barriers to exercise above that of the general population including lack of transportation to PA facilities and programs, social support… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Exergaming
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2026to 31 Oct 2027
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Wheelchair users who have only the use of their arms for exercise
Who may be able to join
- uses a wheelchair
- medically stable (e.g. not currently undergoing rehabilitation or treatment for a medical problem)
- has only the use of their upper limbs for exercise
- lives within one hour driving time from the research center
- has adequate upper limb strength and function to operate an arm ergometer
- has obtained physician clearance to conduct moderate to vigorous exercise
- has room in their home or residence to accommodate the ParaCycle and internet connection
Who cannot join
- history of fractures or dislocations in the upper extremity from which the participant has not fully recovered
- upper limb pain or injury that interferes with the ability to perform aerobic exercise
- recent hospitalization for any reason (within the past three months)
- history of coronary artery disease, coronary bypass surgery or other cardiorespiratory events or conditions
- likely to experience clinically significant autonomic dysreflexia and/ or orthostatic hypotension in response to exercise
- any other conditions that the persons primary care physician deems is a contraindication to participation in arm ergometry exercise stress testing or moderate to vigorous exercise
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
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Rachel Socrates, MA, (412) 360-2384, VHAPTHIRB@va.gov
Alicia M Koontz, PhD
About this study
Physical activity (PA) levels among Veterans who use wheelchairs is very low despite the importance of PA in improving overall physical and mental health. Wheelchair users face many barriers to exercise above that of the general population including lack of transportation to PA facilities and programs, social support, motivation and access to accessible fitness equipment and knowledgeable trainers. Home-based fitness products involving access to live and on-demand video instruction and virtual reality applications have become widely popular and beneficial for increasing fitness and motivation among able-bodied individuals during the pandemic however they are not accessible or tailored to the needs of wheelchair users. Therefore, the goal of this project is to develop a home-based upper arm exercise bike that will be compatible with video based instruction and virtual reality real-world riding apps that offer social components and motivational features.
Read the detailed description
Veterans who use wheelchairs are often prescribed physical activity (PA) in an effort to manage weight and improve cardiovascular health and function however few wheelchair users are currently meeting the recommended amounts of moderate to vigorous aerobic activity (3 times per week ~30 minutes per session). There are many barriers to achieving ample PA including lack of transportation to PA facilities and programs, social support, motivation and access to accessible fitness equipment and knowledgeable trainers. An accessible, motivating, socially supported, and effective exercise option that wheelchair users can participate in from home could help mitigate these barriers to engaging in routine PA. With the onset of the pandemic came a wealth of home-based smart connected exercise devices and fitness apps that enable for interactive video based instruction, virtual/augmented reality world exercise experiences, and integrated social networking features (e.g. group exercise, leaderboards) for the able-bodied market. These applications have been found to improve intrinsic motivation through social support and enjoyment in addition to PA levels and performance. However, these technologies are largely exclusive of persons with disabilities due to the inability to use the connected fitness equipment. Current upper-arm ergometers have limited internet connectivity. Handcycles can be adapted to smart connected bike trainers for use in the home but they require a customized set up that requires a difficult transfer and a lot of space. Therefore, we propose to develop a home-based, smart connected upper-arm ergometer that would enable wheelchairs users to more easily and effectively participate in video and virtual reality-based fitness apps that have social components and motivational features. The specific aims of this study are: 1) to iteratively develop a prototype home-based, smart connected upper-arm cycling trainer (ParaCycle) 2) verify the functionality of the ParaCycle through in lab testing with wheelchair users; and 3) conduct a 6-week in-home pilot study with the refined ParaCycle prototype to evaluate its functionality, safety, utility and device satisfaction.
- Conditions
- Exergaming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paracycle Users | Single cohort study. Participants are testing out the Paracycle in their home for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
Overall reactions to the device on a scale that ranges from 0 (frustrating) to 9 (satisfying).
Measured: After 6 weeks (Trial end)
Secondary outcomes (2)
Adherence Rate
Number of sessions performed during the study period expressed as a percentage of the total number of sessions expected (18).
Measured: After 6 weeks (Trial end)
Retention Rate
Number of participants who complete the study expressed as a percentage of the total number of participants enrolled in the study.
Measured: After 6 weeks (Trial End)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start21 Oct 2026 (estimated)
- Primary completion4 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExergamingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alicia M Koontz, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189546
- Sponsor's protocol ID
- B4249-R
- Acronym
- ParaCycle
- Status last verified
- May 2026
- First submitted
- 16 Sep 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data can be made available upon request from the PI and with an approved Data Use Agreement through the VA
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Socially Connected Exercise System for Wheelchair Users
- ClinicalTrials.gov ID
- NCT07189546
- Acronym / sponsor ID
- ParaCycle / B4249-R
- Conditions
- Exergaming
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 4 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 24 Sep 2025 (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.
Physical activity (PA) levels among Veterans who use wheelchairs is very low despite the importance of PA in improving overall physical and mental health. Wheelchair users face many barriers to exercise above that of the general population including lack of transportation to PA facilities and programs, social support, motivation and access to accessible fitness equipment and knowledgeable trainers. Home-based fitness products involving access to live and on-demand video instruction and virtual reality applications have become widely popular and beneficial for increasing fitness and motivation among able-bodied individuals during the pandemic however they are not accessible or tailored to the needs of wheelchair users. Therefore, the goal of this project is to develop a home-based upper arm exercise bike that will be compatible with video based instruction and virtual reality real-world riding apps that offer social components and motivational features.
Detailed description
Veterans who use wheelchairs are often prescribed physical activity (PA) in an effort to manage weight and improve cardiovascular health and function however few wheelchair users are currently meeting the recommended amounts of moderate to vigorous aerobic activity (3 times per week ~30 minutes per session). There are many barriers to achieving ample PA including lack of transportation to PA facilities and programs, social support, motivation and access to accessible fitness equipment and knowledgeable trainers. An accessible, motivating, socially supported, and effective exercise option that wheelchair users can participate in from home could help mitigate these barriers to engaging in routine PA. With the onset of the pandemic came a wealth of home-based smart connected exercise devices and fitness apps that enable for interactive video based instruction, virtual/augmented reality world exercise experiences, and integrated social networking features (e.g. group exercise, leaderboards) for the able-bodied market. These applications have been found to improve intrinsic motivation through social support and enjoyment in addition to PA levels and performance. However, these technologies are largely exclusive of persons with disabilities due to the inability to use the connected fitness equipment. Current upper-arm ergometers have limited internet connectivity. Handcycles can be adapted to smart connected bike trainers for use in the home but they require a customized set up that requires a difficult transfer and a lot of space. Therefore, we propose to develop a home-based, smart connected upper-arm ergometer that would enable wheelchairs users to more easily and effectively participate in video and virtual reality-based fitness apps that have social components and motivational features. The specific aims of this study are: 1) to iteratively develop a prototype home-based, smart connected upper-arm cycling trainer (ParaCycle) 2) verify the functionality of the ParaCycle through in lab testing with wheelchair users; and 3) conduct a 6-week in-home pilot study with the refined ParaCycle prototype to evaluate its functionality, safety, utility and device satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paracycle Users | – | –Single cohort study. Participants are testing out the Paracycle in their home for 6 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wheelchair users who have only the use of their arms for exercise
Key inclusion criteria (7 listed)
- uses a wheelchair
- medically stable (e.g. not currently undergoing rehabilitation or treatment for a medical problem)
- has only the use of their upper limbs for exercise
- lives within one hour driving time from the research center
- has adequate upper limb strength and function to operate an arm ergometer
Key exclusion criteria (6 listed)
- history of fractures or dislocations in the upper extremity from which the participant has not fully recovered
- upper limb pain or injury that interferes with the ability to perform aerobic exercise
- recent hospitalization for any reason (within the past three months)
- history of coronary artery disease, coronary bypass surgery or other cardiorespiratory events or conditions
- likely to experience clinically significant autonomic dysreflexia and/ or orthostatic hypotension in response to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satisfaction
Time frame: After 6 weeks (Trial end)
Overall reactions to the device on a scale that ranges from 0 (frustrating) to 9 (satisfying).
2 secondary outcomes
Adherence Rate
Time frame: After 6 weeks (Trial end)
Retention Rate
Time frame: After 6 weeks (Trial End)
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 7 May 2026.
- Individual participant dataSharing planned: No. De-identified data can be made available upon request from the PI and with an approved Data Use Agreement through the VA
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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.
Alicia M Koontz, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exergaming, run by VA Office of Research and Development 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 May 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. 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 Nikitha Deepak, MS BS ((412) 822-3669, nikitha.deepak@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction (time frame: After 6 weeks (Trial end)). 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 7 May 2026.