NCT06847074 Rise & Shine: Promoting Sleep Quality in Chronic Stroke With Exercise
| NCT ID | NCT06847074 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2028-05-15 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2025-05-15 with a primary completion date of 2028-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
health problems, such as heart disease, diabetes, cognitive impairment, and dementia. After a person suffers a stroke, they often experience difficulties in getting a good night's sleep. Approximately half of stroke survivors have insomnia, or have trouble falling and/or staying asleep. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors need strategies to promote better sleep. Fortunately, evidence shows that sleep quality can be improved with exercise, even among those who struggle with insomnia. Whether exercise training can improve sleep quality in adults with chronic stroke (i.e., at least 12 months has passed since their stroke) and poor sleep quality is not known. In addition, it is unknown if improved sleep is associated with improved outcomes in those with chronic stroke. This study will specifically evaluate the effect of twice-weekly targeted exercise training on sleep quality over a 6-month period in persons with chronic stroke and poor sleep quality. This study will also evaluate the effect of exercise on the following outcomes: 1) sleep structure; 2) fatigue; 3) daytime sleepiness; 4) mood; 5) physical function and capacity; 6) thinking abilities; 7) heart health; and 8) quality of life. Finally, this study will examine how changes in sleep quality may be related to changes in these outcomes. Our proposed research is timely as the importance of sleep to recovery, health, and wellbeing post-stroke is increasingly recognized.
Eligibility 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.
Contact & Investigator
Teresa Liu-Ambrose, PhD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT06847074 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06847074 currently recruiting?
Yes, NCT06847074 is actively recruiting participants. Contact the research team at teresa.ambrose@ubc.ca for enrollment information.
Where is the NCT06847074 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT06847074 clinical trial?
NCT06847074 is sponsored by University of British Columbia. The principal investigator is Teresa Liu-Ambrose, PhD at University of British Columbia. The trial plans to enroll 62 participants.
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