Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this mixed-methods pilot crossover study is to determine the feasibility (participant satisfaction, recruitment rate, participant and assessor burden, adherence, equipment and technology issues, and safety) of virtual and in-person LYB yoga for adult people with lived experience of stroke in Nova Scotia who are at least three months post stroke.
The secondary objective is to estimate the efficacy of virtual and in-person yoga for improving balance, walking, mobility, mental health (anxiety and depression), and other health outcomes (pain, sleep, health perception, and falls).
The tertiary objective is to estimate the extent to which cognitive function, fatigue, and health-related quality of life co-evolve with our secondary outcomes.
Participants will engage in LYB Yoga virtual and in-person classes for 90 minutes each, twice per week, as well as one 60-minute recorded class completed on their own time.
LoveYourBrain (LYB) is a six-week manualized Yoga program that was originally developed for traumatic brain injury (TBI) patients. The sessions involve meditation, breathing, a variety of Yoga postures, and psychoeducation and discussion components. The program contains key aspects of neuroplasticity and motor learning, which are essential for promoting stroke recovery.
This program can be adapted to suit the needs of the subacute and chronic stroke survivor population: adjusting postures to allow for people with stroke to participate, as well as a variety of seated and standing options will be made available in the LYB Yoga program. This program will also involve group discussion, educational activities, and coping strategies to help with stroke recovery, while creating a sense of community and mutual understanding.
The program has not yet been offered in the stroke context, nor is it available across Nova Scotia. Therefore, the main aim of this study is to test the feasibility of adapting LYB for the stroke context and making it widely available across Nova Scotia in a virtual and in-person format.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person LoveYourBrain Yoga | Experimental | Participants will engage in a 90-minute in-person class that will consist of 10 minutes of breathing, 45 minutes of Yoga postures, 15 minutes of meditation, and 20 minutes of psychoeducation and discussion. Additionally, participants will complete a 45- to 60-minute recorded class on their own time. |
|
| Virtual LoveYourBrain Yoga | Experimental | Participants will engage in a 90-minute virtual class that will consist of 10 minutes of breathing, 45 minutes of Yoga postures, 15 minutes of meditation, and 20 minutes of psychoeducation and discussion. Additionally, participants will complete a 45- to 60-minute recorded class on their own time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoveYourBrain Yoga | Behavioral | The LoveYourBrain Yoga program consists of various techniques, including: breathing, Yoga postures, meditation, and psychoeducation as well as a group discussion. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Percentage of eligible stroke survivors approached and agree to participate. | Baseline |
| Participant satisfaction | Satisfaction questionnaire | Weekly satisfaction questionnaire (weeks 1-24) via smartphone app |
| Participant and assessor burden | Assessment time | During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Adherence | Class attendance- Weekly surveys via smartphone app and yoga instructor tracking | Weeks 1-24 |
| Equipment | Technical issues during virtual classes- Yoga instructor tracking during each class and interviews at the end of the study | Weeks 1-24 and interviews at the end of 24 weeks |
| Smartphone application | Issues with smartphone application-Weekly smartphone surveys and interviews at the end of the study | Weeks 1-24 and interviews at the end of 24 weeks |
| Safety -Serious Adverse Events | Serious adverse events related to the study | Monitoring during each class (weeks 1-24) and at all 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Balance | Dynamic balance will be assessed using the MiniBESTest | During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Walking | Walking speed will be assessed using the 10-metre walking test |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition | Cognitive function will be assessed using two executive function (n-back and shifting) tests from the Dalhousie Computerized Attention Battery (DalCAB), a digital self-administered cognitive battery. | During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Health-related quality of life |
Inclusion Criteria:
Participants will be eligible if they are an adult (aged 18 or older), living with late subacute or chronic stroke (minimum of three months post stroke), residing in Nova Scotia, capable of walking at least 10-metres independently, with supervision, or with the use of an aid or orthotic, and medically stable for eight weeks prior to the baseline visit. Participants must also be able to follow a three-step command for the purpose of yoga class instruction as recommended by our lead yoga instructor.
Exclusion Criteria:
Participants with severe neglect or other issues affecting their safety and participation will be excluded. Participants with cardiovascular, orthopedic, or neurological diseases other than stroke, impacting walking, balance, and mobility will be excluded. Participants who do not have a stable and reliable internet connection will be excluded.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adria Quigley, PhD | Contact | 902-494-2734 | adriaquigley@dal.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroCommons | Halifax | Canada |
|
De-identified data will be shared upon request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Mobility | Functional mobility will be measured using the 5-times sit-to-stand test | During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Mental health | Mental health related outcomes will be measured using the Patient Health Questionnaire (PHQ-9). Scores of 0-4 represent no mental health related concerns, while scores of 4-27 indicate mild-severe depression symptoms on the PHQ-9. | During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Mental health | Mental health related outcomes will be measured using the General Anxiety Disorder-7 scale. Scores of 0-4 indicate no anxiety, while scores of 5-21 indicate mild-severe symptoms of generalized anxiety on the GAD-7 scale. | During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Health outcomes | The levels of sleep, pain and health perception will be assessed using the Visual Analog Scale, as well as a question about the number of times the person fell within the past week. | Weekly surveys via smartphone app |
Health-related quality of life will be measured using the European Quality of Life Five Dimension (EQ-5D). Participants will rate the 5 items on a 3-point scale with the resulting index score ranging from 0-1 where 0 is the worst health imaginable and 1 is full health. Using the EQ-VAS, participants rate their health on a vertical visual analogue scale labelled from 0-100, with higher scores reflecting better health. |
| During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| Post-stroke fatigue | Fatigue severity will be assessed using the Fatigue Severity Scale, a self-reported questionnaire where higher scores reflect worse fatigue and impact on daily activities. | During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |