Exercise for Insomnia After Stroke

Overseen By Ryan Stein, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Dementia, Parkinson's, OSA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 26 weeks

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether exercise can improve sleep quality in individuals who experienced a stroke at least a year ago and struggle with insomnia. It compares a group engaging in twice-weekly multimodal exercise with another group participating in cognitive and social activities without exercise. The researchers aim to determine if better sleep leads to improvements in mood, physical health, thinking skills, and overall quality of life. Candidates for this trial include those who have had a stroke, have trouble sleeping, and can walk short distances. As an unphased trial, this study offers a unique opportunity to explore non-drug interventions that could enhance overall well-being.

Will I have to stop taking my current medications?

The trial requires that participants either do not start new medications that affect sleep or have been on a stable dose of such medications for at least 6 months before and during the study. If you are on medications that impact sleep, you should not change your dosage during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that exercise can improve sleep for people who have had a stroke. One study found that stroke patients who exercised spent 23% less time awake after falling asleep and experienced 15% fewer disruptions during the night. Another study found that high-intensity exercise improved sleep quality, allowing participants to spend more time asleep while in bed.

These findings suggest that exercise is generally well-tolerated and can enhance sleep for stroke survivors. The studies reported no significant harmful effects from exercise, making it a safe option to consider for better sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using multimodal exercise training to treat insomnia after a stroke because it offers a holistic approach that combines physical, cognitive, and social benefits. Unlike standard treatments like medication or cognitive behavioral therapy, which primarily focus on sleep symptoms, this program integrates moderate-intensity physical activity with group interactions, potentially enhancing overall well-being and recovery post-stroke. Additionally, the social aspect of group-based sessions may improve motivation and adherence, leading to better sleep and stroke recovery outcomes.

What evidence suggests that this trial's treatments could be effective for improving sleep quality in stroke survivors?

Research has shown that exercise can greatly improve sleep quality for stroke patients. In this trial, participants in the Multimodal Exercise Training arm will engage in moderate-intensity, multimodal exercise training. One study found that high-intensity rehabilitation exercise helped stroke patients sleep better. Another study showed that exercise reduced the time spent awake after falling asleep by 23% and decreased nighttime disruptions by 15%. Combining aerobic and resistance exercises has also improved sleep for people with sleep problems. These findings suggest that exercise might help those struggling with sleep after a stroke. ^{1 2 5 6 7}

Who Is on the Research Team?

Teresa Liu-Ambrose, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for adults who had a stroke at least 12 months ago and are now struggling with poor sleep quality. Participants should be interested in improving their sleep through exercise but the specific eligibility criteria have not been provided.

Inclusion Criteria

Baseline MMSE score of > 22/30 and a MoCA score of > 19/30

Community-dwelling

I am 55 years old or older.

Exclusion Criteria

I have been diagnosed with sleep apnea and do not use a CPAP machine.

I have been diagnosed with a neurodegenerative condition like Parkinson's.

At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 26-week multimodal exercise training program or cognitive and social activities program

26 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Exercise

Trial Overview

The study tests if targeted exercise training twice a week can improve sleep quality over six months in chronic stroke survivors. It also looks at how better sleep might affect fatigue, mood, physical function, thinking abilities, heart health, and overall life quality.

How Is the Trial Designed?

Group I: Multimodal Exercise Training Experimental Treatment 1 Intervention

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

Group II: Cognitive and Social Activities (No Exercise) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Vancouver Coastal Health Research Institute

Collaborator

Trials

30

Recruited

5,600+

Published Research Related to This Trial

The pilot study involving 37 inactive adults with insomnia showed that zero-time exercise (ZTEx) significantly reduced insomnia severity compared to sleep hygiene education, with a large effect size observed at weeks two, four, and six.

Although the initial benefits of ZTEx diminished by week eight, the training was well-received, with high adherence rates, indicating its potential as a feasible intervention for improving insomnia in inactive adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Yeung, WF., Lai, AY., Ho, FY., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12256198/

Sleep following A Stroke: Multimodal Evaluation of ...

Results: Over inpatient stays, sleep improved with a 23% reduction in wake after sleep onset and 15% fewer multiple overnight disruptions. GLMs ...

2.

researchgate.net

researchgate.net/publication/391486756_Sleep_Following_a_Stroke_Multimodal_Evaluation_of_Sleep_Health_and_Disruptions_and_Impact_on_Recovery_During_Acute_Inpatient_Rehabilitation

Multimodal Evaluation of Sleep Health and Disruptions ...

Conclusions: High-intensity rehabilitation exercise had a significant positive effect on sleep efficiency in the observed patients with stroke. Rehabilitation ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11222904/

Exercise therapy in the application of sleep disorders - PMC

The results showed that combined aerobic-resistance exercise could improve sleep quality in patients with sleep disorders, enhance subjective ...

4.

journals.sagepub.com

journals.sagepub.com/doi/full/10.1177/1545968320962501

The Impact of Sleep Disorders on Functional Recovery and ...

The mean mRS score was 0.51 points higher in participants with stroke and sleep disorders versus participants with stroke without sleep disorder ...

5.

nature.com

nature.com/articles/s41598-018-26630-y

Post-stroke insomnia in community-dwelling patients with ...

Behavioural and physiological measures suggested that stroke patients had poorer sleep with longer sleep latencies and lower sleep efficiency.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8084092/

Exercise intervention for sleep disorders after stroke

This study aims to explore the effects of exercise on sleep disorders after stroke and to establish safe and effective exercise prescriptions.

7.

mdpi.com

mdpi.com/1424-8220/22/16/6190

Sleep Monitoring during Acute Stroke Rehabilitation

After stroke, an estimated 27% of patients report hypersomnia and excessive daytime sleepiness [2], while an estimated 57% of patients report insomnia [3]. Poor ...