Motion-based virtual cycling to improve quality of life for people with cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.