About this trial
The primary objective of this mixed-methods pilot crossover study is to determine the feasibility (participant satisfaction, recruitment rate, retention, 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 cognition, fatigue, and health-related quality of life change following the LYB program.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
LoveYourBrain Yoga
BehavioralThe LoveYourBrain Yoga program consists of various techniques, including: breathing, Yoga postures, meditation, and psychoeducation as well as a group discussion.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate
Percentage of eligible stroke survivors approached and agree to participate.
Participant satisfaction
Satisfaction questionnaire
Participant retention
Percentage of of participants who complete the LYB program
Participant and assessor burden
Assessment time
Secondary outcomes
Balance
Dynamic balance will be assessed using the MiniBESTest
Walking
Walking speed will be assessed using the 10-metre walking test
Mobility
Functional mobility will be measured using the 5-times sit-to-stand test
Mental health
Mental health related outcomes will be measured using the Patient Health Questionnaire (PHQ-9). Scores of 0-4 indicate none to minimal depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Other outcomes
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.
Health-related quality of life
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.
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.
Sponsors and contacts
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Nova Scotia Health Authority
Lead sponsor
Dalhousie University
Sponsor institution