Development of a Socially Connected Exercise System for Wheelchair Users

NCT07189546 | Not Yet Recruiting

• 1 other identifier: B4249-R
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Exergaming

Outcome Measures

Primary Outcomes (1)

• Satisfaction

  Overall reactions to the device on a scale that ranges from 0 (frustrating) to 9 (satisfying).

  After 6 weeks (Trial end)

Secondary Outcomes (2)

• Adherence Rate

  After 6 weeks (Trial end)

• Retention Rate

  After 6 weeks (Trial End)

Study Arms (1)

Paracycle Users

Single cohort study. Participants are testing out the Paracycle in their home for 6 weeks.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Wheelchair users who have only the use of their arms for exercise

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Biospecimen

Retention: NONE RETAINED

There are no biospecimens collected in this study.

Study Officials

• Alicia M Koontz, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikitha Deepak, MS BS

CONTACT

(412) 822-3669; nikitha.deepak@va.gov

Alicia M Koontz, PhD

CONTACT

(412) 383-6596; Alicia.Koontz@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: April 6, 2026
• Primary Completion (Estimated): October 4, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)