Integrated Tele-exercise for Individuals With Spinal Cord Injury - Trial NCT05360719

Timeline & Enrollment

Primary Outcome

Change in narrative responses from focus group interviews at Week 8,Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) at Week 8,Change in pain interference on the Spinal Cord Injury Quality of Life - Measurement System-Pain Interference Short Form at Week 8,Change in pain behavior on the Spinal Cord Injury Quality of Life Measurement System-Pain Behavior Short Form at Week 8,Change in self-esteem on the Spinal Cord Injury Quality of Life Measurement System-Self-Esteem Short Form at Week 8,Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form at Week 8,Change in resilience on the Spinal Cord Injury Quality of Life Measurement System-Resilience Short Form at Week 8,Change in positive affect and well-being on the Spinal Cord Injury Quality of Life Measurement System-Positive Affect and Wellbeing Short Form at Week 8,Change in participation in social roles on the Spinal Cord Injury Quality of Life Measurement System-Participation in Social Roles and Activities Short Form at Week 8,Change in satisfaction with social roles on the Spinal Cord Injury Quality of Life Measurement System-Satisfaction with Social Roles and Activities Short Form at Week 8,Change in sleep disturbance on the General Sleep Disturbance Scale at Week 8,Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 8,Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 8,Change in leisure time physical activity behavior on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) at Week 8

Summary

The objective of this study is to examine the efficacy of an integrated, participant-centered
 tele-health physical activity program for individuals with SCI on psychological and social
 factors through a parallel mixed-methods design approach. We will examine changes in
 psychological (self-efficacy, self-esteem, exercise outcome expectations, depression,
 positive affect and well-being, quality of life) and social factors (participation and
 satisfaction with social roles and activities, activity engagement) following participation
 in an 8-week integrated group tele-exercise health and wellness physical activity program,
 with retention assessed at 8-weeks following completion (16 weeks from baseline). We will
 also complete small group interviews with all participants to understand participant
 experiences of, response to, and recommendations before and following participation in group
 tele-exercise program.
 
 To date, there is extremely limited evidence for the efficacy of psychological and social
 well-being of remotely delivered community-based exercise to individuals with SCI. A pilot
 effectiveness trial of a tele-exercise health and wellness program will be conducted using a
 mixed methods design with a randomized waitlist control group. Quantitative and qualitative
 data collection is sequential in nature and other data are collected simultaneously.
 Individuals with SCI (living with injury 12 months or longer) will be recruited based on
 existing partnerships locally and nationally. To assess limited effectiveness, we aim to
 enroll 35 individuals with SCI. Recruitment of these participants will stem from the
 investigator's ongoing community partnership with local and national partners. The
 tele-exercise health & wellness program will consist of virtual group class, twice per week,
 intended to generate physical confidence and strength for individuals living with SCI. Each
 session will be co-led with by an individual living with SCI.

ICD-10 Classifications