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NCT Number: NCT06847074

Rise & Shine: Promoting Sleep Quality in Chronic Stroke With Exercise

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver Coastal Health Research Institute Research Pavilion

Vancouver, British Columbia, V5Z 1L8, Canada

Location status: Recruiting

Location contact

Nathan Wei, B.SC

CONTACT

[email protected]

604-875-4111 ext. 69056

Teresa Liu-Ambrose, Ph.D

PRINCIPAL_INVESTIGATOR

About this study

Approximately half of stroke survivors have insomnia. 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 are a target population in need of intervention strategies to promote sleep quality.

Current research and stroke rehabilitation do not address the sleep consequences of stroke - especially for those in the chronic phase (i.e., = or > 12 months since an index stroke). Adults with chronic stroke have lower sleep efficiency compared with sex- and age-matched controls. Poor sleep quality in chronic stroke is associated with depression, impaired physical function, and reduced cognitive function.

How to effectively treat insomnia in adults with chronic stroke is not well established. Intervention studies show exercise improves sleep quality and structure. Whether exercise can improve sleep quality in adults with chronic stroke and poor sleep quality is not established.

Primary Question: In adults with chronic stroke and poor sleep quality, can a 26-week multimodal exercise training program of moderate intensity (EX) improve sleep efficiency, as objectively measured by the actigraphy, compared with a 26-week cognitive and social activities program (CON; active control group)?

Secondary Question: What are additional benefits of EX vs. CON? Compared with CON, we will evaluate the effect of EX on: 1) actigraphy-measured sleep parameters of latency, duration, and wake after sleep onset; 2) sleep architecture by frontal electroencephalography; 3) subjective sleep quality; 4) fatigue; 5) daytime sleepiness; 6) mood; 7) functional capacity; 8) cognitive function; 9) cardiometabolic risk factors; and 10) quality of life.

Tertiary Question: Are changes in sleep quality associated with changes in: 1) fatigue; 2) daytime sleepiness; 3) mood; 4) cognitive function; 5) cardiometabolic risk factors; and 6) quality of life?

Pilot Data: Using actigraphy, the investigators acquired sleep data from 21 of 120 (i.e., subset) participants with chronic stroke enrolled in a RCT with cognitive function as the primary outcome. These 21 participants (mean age=69) were randomized to 26 weeks of: 1) multimodal exercise of moderate intensity (EX; n=12); or 2) cognitive and social activities (i.e., no exercise; CON; n=9). Of these 21 participants, 48% had a baseline actigraphy-measured sleep efficiency < 85%. Compared with CON, EX significantly improved actigraphy-measured sleep efficiency values (in %) at 13 weeks and 26 weeks.

Methods: A 26-week, assessor-blinded, single-site RCT of 62 community-dwelling adults with chronic stroke, WatchPAT measured sleep efficiency < 85%, Pittsburgh Sleep Quality Index global score > 5, and aged 55 years and older. Individuals will be randomized to one of two experimental groups: 1) twice-weekly EX (n=31); or 2) twice-weekly CON (n=31). Randomization will be stratified by sex and age. Measurement will occur at baseline, 13 weeks, and 26 weeks, unless otherwise stated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal exercise

Behavioral

Each 60-minute class will include a 10-minute warm-up (i.e., stretches for the major muscles and walking on the spot), 40 minutes of training, and a 10-minute cool down (i.e., stretches and relaxation techniques).Instructors will use heart rate monitors to continuously track intensity during and across all sessions.

Cognitve and Social Activities

Behavioral

Each 60-minute class will include 30 minutes of cognitive enrichment activities and 30 minutes of activities that promote social interactions.

Primary outcomes

  1. Sleep Efficiency

    Time frame: Baseline, 13 weeks, 26 weeks

    Sleep efficiency as measured by actigraphy over days of wear.

Secondary outcomes

  1. Sleep latency, duration, and wake after sleep onset

    Time frame: Baseline, 13 weeks, 26 weeks

    Sleep latency, duration, and wake after sleep onset by actigraphy over days of wear.

  2. Sleep Architecture (OPTIONAL)

    Time frame: Baseline, 13 weeks, 26 weeks

    Sleep architecture as measured by EEG headband

  3. Subjective sleep quality

    Time frame: Baseline, 13 weeks, 26 weeks

    Subjective sleep quality measured by Pittsburgh Sleep Quality Index

  4. Fatigue

    Time frame: Baseline, 13 weeks, 26 weeks

    Fatigue measured by Fatigue Severity Scale

  5. Sleepiness

    Time frame: Baseline, 13 weeks, 26 weeks

    Daytime sleepiness measured by questionnaire

  6. Mood

    Time frame: Baseline, 13 weeks, 26 weeks

    Depressive symptoms measured by questionnaire

  7. Functional Capacity

    Time frame: Baseline, 13 weeks, 26 weeks

    Functional capacity, or aerobic capacity, measured by the 6-Minute Walk Test

  8. NIH Toolbox Cognitive Battery

    Time frame: Baseline, 13 weeks, 26 weeks

    Cognitive function measured by NIH Toolbox Cognitive Battery

  9. ADAS-Cog Plus

    Time frame: Baseline, 13 weeks, 26 weeks

    Cognitive function measured by ADAS-Cog Plus

  10. Executive Functions

    Time frame: Baseline, 13 weeks, 26 weeks

    The domain of executive functions measured by Trails A and B, Digits Forward and Backward, and Clock Drawing

  11. Verbal Fluency

    Time frame: Baseline, 13 weeks, 26 weeks

    Verbal fluency measured by categorical fluency

  12. Memory

    Time frame: Baseline, 13 weeks, 26 weeks

    Memory measured by the Rey Auditory Verbal Fluency

  13. Blood Pressure

    Time frame: Baseline, 13 weeks, 26 weeks

    Systolic and diastolic blood pressure

  14. Chronotype

    Time frame: Baseline, 13 weeks, 26 weeks

    Chronotype measured by questionnaire

  15. Blood Biomarkers (OPTIONAL)

    Time frame: Baseline, 13 weeks, 26 weeks

    We will draw blood to assess markers cardiometabolic health and brain health

  16. Quality of life

    Time frame: Baseline, 13 weeks, 26 weeks

    Quality of life measured by the EuroQol-5 Domain-5 Level (EQ-5D-5L)

  17. Current Physical Activity (Self-Report)

    Time frame: Baseline, 13 weeks, 26 weeks

    Physical activity outside of research study will be assessed by questionnaire

  18. Balance and Mobility

    Time frame: Baseline, 13 weeks, 26 weeks

    Balance and mobility measured by the Short Physical Performance Battery

  19. Activities of Daily Living

    Time frame: Baseline, 26 weeks

    Lawton and Brody Instrumental Activities of Daily Living Scale will asssess activites of daily living

  20. Arterial Stiffness

    Time frame: Baseline, 13 weeks, 26 weeks

    Arterial stiffness will be measured as pulse wave velocity

  21. Sedentary Behaviour

    Time frame: Baseline, 13 weeks, 26 weeks

    Time in sedentary behaviour will be measured by actigraphy over days of wear.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Stein, MSc

CONTACT

[email protected]

Teresa Liu-Ambrose, PhD

CONTACT

[email protected]

604-617-8047

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Vancouver Coastal Health Research Institute

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 26, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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