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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07143162
Acronym
YOGA-FIT
Enrollment
40
Registered
2025-08-27
Start date
2026-08-01
Completion date
2027-12-10
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Yoga, LoveYourBrain, Virtual rehabilitation

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALLoveYourBrain Yoga

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

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rateBaselinePercentage of eligible stroke survivors approached and agree to participate.
Participant satisfactionWeekly satisfaction questionnaire (weeks 1-24) via smartphone appSatisfaction questionnaire
Participant retentionWeeks 1-24Percentage of of participants who complete the LYB program
Participant and assessor burdenDuring the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)Assessment time
AdherenceWeeks 1-24Class attendance- Weekly surveys via smartphone app and yoga instructor tracking
EquipmentWeeks 1-24 and interviews at the end of 24 weeksTechnical issues during virtual classes- Yoga instructor tracking during each class and interviews at the end of the study
Smartphone applicationWeeks 1-24 and interviews at the end of 24 weeksIssues with smartphone application-Weekly smartphone surveys and interviews at the end of the study
Safety -Serious Adverse EventsMonitoring 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

MeasureTime frameDescription
BalanceDuring the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)Dynamic balance will be assessed using the MiniBESTest
WalkingDuring the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)Walking speed will be assessed using the 10-metre walking test
MobilityDuring the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)Functional mobility will be measured using the 5-times sit-to-stand test
Mental healthDuring 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 indicate none to minimal depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Health outcomesWeekly surveys via smartphone appThe 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.

Countries

Canada

Contacts

CONTACTAdria Quigley, PhD
adriaquigley@dal.ca902-494-2734

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026