YOGA-FIT: Protocol for a Crossover Trial Investigating the Feasibility and Impact of Yoga for People With Stroke

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • LoveYourBrain Yoga

    Behavioral

    The LoveYourBrain Yoga program consists of various techniques, including: breathing, Yoga postures, meditation, and psychoeducation as well as a group discussion.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: In-person LoveYourBrain YogaExperimental treatment 1 intervention
Group B: Virtual LoveYourBrain YogaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

Percentage of eligible stroke survivors approached and agree to participate.

Time frame
Baseline
2

Participant satisfaction

Satisfaction questionnaire

Time frame
Weekly satisfaction questionnaire (weeks 1-24) via smartphone app
3

Participant retention

Percentage of of participants who complete the LYB program

Time frame
Weeks 1-24
4

Participant and assessor burden

Assessment time

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)

Secondary outcomes

1

Balance

Dynamic balance will be assessed using the MiniBESTest

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
2

Walking

Walking speed will be assessed using the 10-metre walking test

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
3

Mobility

Functional mobility will be measured using the 5-times sit-to-stand test

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
4

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.

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)

Other outcomes

1

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.

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
2

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.

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)
3

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.

Time frame
During the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

Dalhousie University

Sponsor institution