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

Trial Summary

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.

What data supports the effectiveness of the treatment Multimodal Exercise for insomnia after stroke?

Research suggests that exercise can help improve sleep and reduce fatigue in people who have had a stroke, although the exact impact is not fully clear. Additionally, exercise has been shown to improve sleep in older adults with insomnia, indicating potential benefits for similar conditions. ^{1 2 3 4 5}

Is exercise safe for people with insomnia or after a stroke?

Exercise is generally considered a safe, low-cost treatment for improving sleep and reducing fatigue in people with chronic stroke and insomnia. However, some studies have concerns about bias and quality, so more research is needed to confirm these findings. ^{1 3 6 7 8}

How does the Multimodal Exercise treatment for insomnia after stroke differ from other treatments?

Multimodal Exercise is unique because it combines various forms of physical activity to improve sleep in stroke patients, offering a low-cost, non-drug approach that may also reduce fatigue, unlike traditional treatments that often rely on medication. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Research Team

Teresa Liu-Ambrose, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

I am 55 years old or older.

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

Community-dwelling

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Can exercise training promote better sleep and reduced fatigue in people with chronic stroke? A systematic review. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise intervention for sleep disorders after stroke: A protocol for systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Post-stroke insomnia in community-dwelling patients with chronic motor stroke: Physiological evidence and implications for stroke care. [2023]

6. Brazil pubmed.ncbi.nlm.nih.gov

Physical exercise as a therapeutic approach for adults with insomnia: systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of acute physical exercise on patients with chronic primary insomnia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Does exercise improve sleep for adults with insomnia? A systematic review with quality appraisal. [2021]