Improving sleep quality in stroke survivors through exercise
Rise & Shine: Promoting Sleep Quality in Chronic Stroke With Exercise
This study is testing if a 26-week exercise program can help stroke survivors sleep better compared to those doing social activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06847074 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a 26-week multimodal exercise training program on sleep quality in adults who have experienced a stroke at least one year prior. Participants will engage in targeted exercise sessions twice a week, with the aim of improving sleep efficiency as measured by actigraphy. The study also includes a control group that will participate in cognitive and social activities to compare outcomes. The primary focus is to determine if exercise can enhance sleep quality and associated health outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 55 and older who have experienced a stroke at least one year prior and exhibit poor sleep quality.
Not a fit: Patients who are not community-dwelling or those who have stable medication regimens affecting sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall health outcomes for stroke survivors.
How similar studies have performed: Previous studies have shown that exercise can improve sleep quality, suggesting potential success for this approach in stroke survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: We will include community-dwelling adults who had an ischemic or hemorrhagic stroke at least one year prior to study enrolment and have poor sleep quality - defined as a sleep efficiency of \< or = 85%, with allowance for minor upward deviations on individual nights consistent with known night-to-night variability and instrument accuracy limits, and a PSQI global score of \> 5. Individuals must also meet these inclusion criteria: 1) aged 55 years and older; 2) a baseline MMSE score of = or \> 22/30 and a MoCA score of = or \> 19/30; 3) community-dwelling; 4) able to comply with scheduled assessments, classes, and other trial procedures; 5) read, write, and speak English with acceptable visual and auditory acuity; 6) not to start or stable (i.e., = or \> 6 months) on a fixed dose of medication that impacts sleep (i.e., anti-arrhythmics, beta blockers, selective serotonin reuptake inhibitor, etc.) during the 26-week intervention period; 7) able to walk for a minimum of six metres with rest intervals with or without assistive devices; 8) based on interview, have an activity tolerance of 60 minutes with rest intervals; 9) not participating in any regular therapy or progressive exercise (e.g., treadmill or weight-lifting); and 10) able to safely engage in exercise as indicated by the PAR-Q+63 and written confirmation by family or study physicians. Exclusion Criteria: We will exclude individuals who: 1) are diagnosed with OSA and are not using CPAP or defined as potentially having undiagnosed OSA (AHI \> 20) as a result of study screening; 2) have restless leg syndrome; 3) are diagnosed with dementia of any type; 4) are diagnosed with another type of neurodegenerative or neurological condition (e.g., Parkinson's disease); 5) are planning to participate, or already enrolled in, a clinical drug trial or exercise trial concurrent to this study; 6) are at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level; 7) have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her physician; or 8) have aphasia as judged by an inability to communicate by phone.
Where this trial is running
Vancouver, British Columbia
- Vancouver Coastal Health Research Institute Research Pavilion — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Teresa Liu-Ambrose, PhD — University of British Columbia
- Study coordinator: Teresa Liu-Ambrose, PhD
- Email: teresa.ambrose@ubc.ca
- Phone: 604-617-8047
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.