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Feasibility, Usability and Safety of an Intelligent Mobile Fitness App (ParaGym) for People with Paraplegia: A Pilot Block Randomised Controlled Trial

Feasibility, Usability and Safety of an Intelligent Mobile Fitness App (ParaGym) for People with Paraplegia: A Pilot Block Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030370
Enrollment
45
Registered
2022-10-25
Start date
2022-11-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G82.0 G82.1 G82.2

Interventions

Group 1: people with chronic paraplegia, exercising with the ParaGym mobile app for 6 weeks Group 2: waitlist control group

Sponsors

Institut für Kreislaufforschung und Sportmedizin, ABt. 1 Deutsche Sporthochschule Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 67 Years

Inclusion criteria

Inclusion criteria: chronic paraplegia (time since injury > 1 year), between 18 and 67 years old, sufficient German language skills, capable of providing informed consent, access to a smartphone

Exclusion criteria

Exclusion criteria: high performance athlete (national team), acute infection, uncontrolled hypertension or diabetes, manifest cardiovascular diseases, medical contraindications, psychiatric or mental conditions that compromise informed consent or may interfere with the study/study results (e.g. major depression, psychotic disorders), ongoing alcohol or substance abuse, negative outcome to unsupervised exercise based on a medical screening

Design outcomes

Primary

MeasureTime frame
Feasibility (training protocol/self-report, semistructured interviews, drop-outs, adherence, app usage data (completed workouts)) Usability (System Usability Scale (SUS)) Safety (adverse events)

Secondary

MeasureTime frame
preliminary efficacy: independence in everyday life (Spinal Cord Independence Measure (SCIM III); quality of life (SF-36); performance (spiroergometry (arm crank ergometer): maximum oxygen uptake (VO2max), maximum/peak power output (POmax/peak) (Watt), heart rate, blood pressure, rating of perceived exertion (BORG-RPE); strength (hand grip strength, using a hand dynamometer)

Countries

Germany

Contacts

Public ContactJanika Bolz

Deutsche Sporthochschule Köln

j.bolz@dshs-koeln.de+49 221 4982 5271

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 13, 2026