Motion-based virtual cycling to improve quality of life for people with cognitive impairment
Motion-based Interactive Technology for Improved Quality of Life in Individuals With Cognitive Impairment
This project will test whether motion-based virtual cycling can improve quality of life for nursing home residents with cognitive impairment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Örebro University, Sweden Academic / other |
| Locations | 1 site (Örebro) |
| Trial ID | NCT06466460 on ClinicalTrials.gov |
What this trial studies
This randomized controlled intervention will enroll about 60–80 nursing home residents with cognitive impairment and randomly assign them to virtual cycling or usual care. The intervention group will pedal a stationary bike while viewing interactive films twice weekly for 8 weeks, with sessions lasting about 40 minutes and delivered at the resident's nursing home. Outcomes include participant questionnaires, physical tests, staff observations and medical-record data collected before and after the intervention, with analyses by intention-to-treat and per-protocol. A second qualitative component will interview residential staff who worked closely with participants to capture staff experiences and implementation issues.
Who should consider this trial
Good fit: Ideal candidates are nursing home residents in Sweden aged over 65 with cognitive impairment (MMSE <24) who can pedal a stationary bike and can provide informed consent.
Not a fit: People who cannot physically pedal, who lack capacity to consent, or who have severe medical or mobility limitations are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could increase physical activity, engagement, mood and overall quality of life for nursing home residents with cognitive impairment.
How similar studies have performed: Previous small studies and feasibility reports of virtual cycling and motion-based exergames have shown improved engagement and mood, but large randomized trials demonstrating clear clinical benefits remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Study 1) Inclusion Criteria: * age more than 65 * resides in a nursing home * cognitive impairment measured by MMSE, scoring \<24 points on the MMSE. Exclusion Criteria: * Individuals who cannot provide their own informed consent will be excluded, in consultation with their relatives/guardians. * Individuals who cannot do the movement to the cycle Study 2) Inclusion Criteria: * no age limits * the residential staff should have worked closely with the participant in the intervention study for three months before the intervention began. * the residential staff should have worked closely with the participant during the duration of the intervention study (16 sessions). * the residential staff should have participated once when the participant conducted the cycling intervention, as the staff member being interviewed. Exclusion Criteria: \- residential staff who are not assessed to understand and speak Swedish to an extent that allows the interview to be conducted will be excluded.
Where this trial is running
Örebro
- School of behavioural, social and legal sciences — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Marie Matérne — Örebro University, Sweden
- Study coordinator: Marie Matérne, PhD
- Email: marie.materne@oru.se
- Phone: +46707961388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.