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

NCT07143162 | Not Yet Recruiting

• 1 other identifier: YOGA-FIT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Yoga; LoveYourBrain; Virtual rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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)

Secondary Outcomes (6)

• Balance

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

• Walking

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

• Mobility

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

• Mental health

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

• Mental health

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

Other Outcomes (3)

• Cognition

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

• Health-related quality of life

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

• Post-stroke fatigue

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

Study Arms (2)

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.

Behavioral: LoveYourBrain Yoga

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.

Behavioral: LoveYourBrain Yoga

Interventions

LoveYourBrain Yoga BEHAVIORAL

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

In-person LoveYourBrain Yoga; Virtual LoveYourBrain Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

NeuroCommons

Halifax, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Adria Quigley, PhD

CONTACT

902-494-2734; adriaquigley@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 27, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CA (1)