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YOGA-FIT: Investigating the Feasibility and Impact of Virtual Versus In-person Yoga for Late Subacute & Chronic Stroke Survivors

Not Applicable
Not yet recruiting
Conditions
Stroke
Registration Number
NCT07143162
Lead Sponsor
Nova Scotia Health Authority
Brief Summary

The main objective of this mixed-methods pilot crossover study is to determine the feasibility of virtual and in-person LYB Yoga for adult stroke survivors in Nova Scotia who are at least three months post stroke or more.

The secondary objective is to estimate the effectiveness 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.

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 hemi-paretic stroke survivor participation, 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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Late subacute or chronic survivor (minimum of 3 months post stroke)
  • Living within 50 km of Halifax, Nova Scotia
  • Capable of walking 10-metres or more independently or with supervision or the use of an aid or orthotic
  • Medically stable for eight weeks prior to the baseline visit
  • Able to follow a three-step command
Exclusion Criteria
  • Severe neglect or other issues affecting safety and participation
  • Cardiovascular, orthopedic, or neurological diseases other than stroke, impacting walking, balance, and mobility
  • Not having access to wifi

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Recruitment rateBaseline

Percentage of eligible stroke survivors approached and agree to participate.

Participant satisfactionWeekly satisfaction questionnaire (weeks 1-24) via smartphone app

Satisfaction questionnaire

Participant and assessor burdenDuring the 4 assessments (Baseline, 6 weeks, 18 weeks, 24 weeks)

Assessment time

AdherenceWeeks 1-24

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

EquipmentWeeks 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

Smartphone applicationWeeks 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

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

Secondary Outcome Measures
NameTimeMethod
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) and General Anxiety Disorder-7 scale. Scores of 0-4 represent no mental health related concerns, while scores of 4-27 indicate mild- severe anxiety or depression symptoms in the PHQ-9. Scores of 0-4 indicate no anxiety, while scores of 5-21 indicate mild-severe symptoms of generalized anxiety on the GAD-7 scale.

Health outcomesWeekly 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.

Trial Locations

Locations (1)

NeuroCommons

🇨🇦

Halifax, Canada

NeuroCommons
🇨🇦Halifax, Canada
Katerina Miller, PT
Contact
902-473-1229
Katerina.Miller@nshealth.ca

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