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

NCT ID: NCT06847074

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2028-06-30

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.

Detailed Description

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.

Conditions

Stroke; Poor Quality Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Multimodal Exercise Training

The program will consist of moderate intensity, multimodal exercise training; 2x/week; in-person, group-based.

Group Type: EXPERIMENTAL

Multimodal Exercise

Intervention Type: 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.

Cognitive and Social Activities (No Exercise)

The program will consist of cognitive and social activites; 2x/week; in-person, group-based

Group Type: ACTIVE_COMPARATOR

Cognitve and Social Activities

Intervention Type: BEHAVIORAL

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

Interventions

Multimodal Exercise

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.

Intervention Type: BEHAVIORAL

Cognitve and Social Activities

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vancouver Coastal Health Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Teresa Liu-Ambrose

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Liu-Ambrose, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver Coastal Health Research Institute Research Pavilion

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Teresa Liu-Ambrose, PhD

Role: CONTACT

teresa.ambrose@ubc.ca

604-617-8047

Ryan Stein, MSc

Role: CONTACT

exsleep.strokestudy@ubc.ca

Facility Contacts

Nathan Wei, B.SC

Role: primary

cogmob.research@hiphealth.ca

604-875-4111 ext. 69056

Other Identifiers

H23-01163

Identifier Type: -

Identifier Source: org_study_id