Recruiting

Exercise

Sponsor:

University of British Columbia

Code:

NCT06847074

Conditions

Stroke

Poor Quality Sleep

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Multimodal Exercise

Cognitve and Social Activities

Study Details

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

Study ID

NCT06847074

Start date

May 15, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Multimodal Exercise Training

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

active comparator: Cognitive and Social Activities (No Exercise)

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

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.

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.

Primary outcome measure

  • Sleep Efficiency [ Time Frame: Baseline, 13 weeks, 26 weeks ]

Central Contacts and Locations

Central contacts

Locations

Vancouver Coastal Health Research Institute Research Pavilion

Recruiting

Vancouver, British Columbia, Canada, V5Z 1L8

Contacts

Principal Investigator:

Teresa Liu-Ambrose, Ph.D

More Information

Sponsor

University of British Columbia

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-06-11.