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NCT Number: NCT07143162

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LoveYourBrain Yoga

Behavioral

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

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline

    Percentage of eligible stroke survivors approached and agree to participate.

  2. Participant satisfaction

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

    Satisfaction questionnaire

  3. Participant and assessor burden

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

    Assessment time

  4. Adherence

    Time frame: Weeks 1-24

    Class attendance- Weekly surveys via smartphone app and yoga instructor tracking

  5. Equipment

    Time frame: Weeks 1-24 and interviews at the end of 24 weeks

    Technical issues during virtual classes- Yoga instructor tracking during each class and interviews at the end of the study

  6. Smartphone application

    Time frame: Weeks 1-24 and interviews at the end of 24 weeks

    Issues with smartphone application-Weekly smartphone surveys and interviews at the end of the study

  7. Safety -Serious Adverse Events

    Time frame: Monitoring during each class (weeks 1-24) and at all 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)

    Serious adverse events related to the study

Secondary outcomes

  1. Balance

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

    Dynamic balance will be assessed using the MiniBESTest

  2. Walking

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

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

  3. Mobility

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

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

  4. Mental health

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

    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.

  5. Mental health

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

    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.

  6. Health outcomes

    Time frame: Weekly surveys via smartphone app

    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.

Other outcomes

  1. Cognition

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

    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.

  2. Health-related quality of life

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

    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.

  3. Post-stroke fatigue

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adria Quigley, PhD

CONTACT

[email protected]

902-494-2734

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Acronym: YOGA-FIT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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