Feasibility, Usability and Safety of an Intelligent Mobile Fitness App (ParaGym) for People with Paraplegia: A Pilot Block Randomised Controlled Trial
Not Applicable
- Conditions
- G82.0G82.1G82.2Flaccid paraplegiaSpastic paraplegiaParaplegia, unspecified
- Registration Number
- DRKS00030370
- Lead Sponsor
- Institut für Kreislaufforschung und Sportmedizin, ABt. 1 Deutsche Sporthochschule Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 39
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility (training protocol/self-report, semistructured interviews, drop-outs, adherence, app usage data (completed workouts))<br>Usability (System Usability Scale (SUS))<br>Safety (adverse events)
- Secondary Outcome Measures
Name Time Method preliminary efficacy:<br>independence in everyday life (Spinal Cord Independence Measure (SCIM III);<br>quality of life (SF-36);<br>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);<br>strength (hand grip strength, using a hand dynamometer)