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

NCT06847074 | Recruiting DMC

• 1 other identifier: H23-01163
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Poor Quality Sleep

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  Sleep efficiency as measured by actigraphy over days of wear.

  Baseline, 13 weeks, 26 weeks

Secondary Outcomes (17)

• Sleep latency, duration, and wake after sleep onset

  Baseline, 13 weeks, 26 weeks

• Sleep architecture (OPTIONAL)

  Baseline, 13 weeks, 26 weeks

• Subjective sleep quality

  Baseline, 13 weeks, 26 weeks

• Fatigue

  Baseline, 13 weeks, 26 weeks

• Sleepiness

  Baseline, 13 weeks, 26 weeks

Study Arms (2)

Multimodal Exercise Training

EXPERIMENTAL

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

Behavioral: Multimodal Exercise

Cognitive and Social Activities (No Exercise)

ACTIVE COMPARATOR

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

Behavioral: Cognitve and Social Activities

Interventions

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.

Cognitive and Social Activities (No Exercise)

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.

Multimodal Exercise Training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator

Study Sites (1)

Vancouver Coastal Health Research Institute Research Pavilion

Vancouver, British Columbia, V5Z 1L8, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Teresa Liu-Ambrose, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Liu-Ambrose, PhD

CONTACT

604-617-8047; teresa.ambrose@ubc.ca

Ryan Stein, MSc

CONTACT

exsleep.strokestudy@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 26, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)