Rise & Shine: Promoting Sleep Quality in Chronic Stroke With Exercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of British Columbia
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal Exercise
BehavioralEach 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
BehavioralEach 60-minute class will include 30 minutes of cognitive enrichment activities and 30 minutes of activities that promote social interactions.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Multimodal Exercise TrainingExperimental treatment 1 intervention
Group B: Cognitive and Social Activities (No Exercise)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Efficiency
Sleep efficiency as measured by actigraphy over days of wear.
Time frame
Baseline, 13 weeks, 26 weeksSecondary outcomes
1
Sleep latency, duration, and wake after sleep onset
Sleep latency, duration, and wake after sleep onset by actigraphy over days of wear.
Time frame
Baseline, 13 weeks, 26 weeks2
Sleep Architecture (OPTIONAL)
Sleep architecture as measured by EEG headband
Time frame
Baseline, 13 weeks, 26 weeks3
Subjective sleep quality
Subjective sleep quality measured by Pittsburgh Sleep Quality Index
Time frame
Baseline, 13 weeks, 26 weeks4
Fatigue
Fatigue measured by Fatigue Severity Scale
Time frame
Baseline, 13 weeks, 26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Vancouver Coastal Health Research Institute
Collaborator
Source ClinicalTrials.gov