Clinical trial NCT05360719: Integrated Tele-exercise for Individuals With Spinal Cord Injury
Official title: Integrated Tele-exercise for Individuals With SCI: Physical, Psychological, and Social Responses With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: physical activity
group online exercise
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
name: Pennsylvania Department of Health
First posted: 2022-05-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: waitlist control repeated measures
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Physical activity participation directly impacts the body function and structures of individuals living with spinal cord injury (SCI). Physical inactivity can initiate and exacerbate secondary conditions that individuals with SCI are predisposed to including pressure sores, urinary tract infections, sleep disorders, and chronic pain. Kinesiophobia, a symptom related to pain, addresses an excessive and often debilitating fear of physical movement and activity and is associated with reduced level of physical activity. Individuals with newly acquired SCI have shown elevated levels of kinesiophobia during inpatient rehabilitation which remained unchanged at one-year. Specific to this proposal, there are numerous psychosocial benefits for individuals with SCI who participate in physical activity. These include reduction of depression and negative mood, increased self-confidence, improved body image, and enhanced quality of life. Qualitative findings support these outcomes in individuals with SCI who reported that physical activity reduced depressive moods, facilitated optimism and positive outlook, and helped manage stress; thus enhancing overall psychological well-being and mental health. Engagement in physical activity is positively associated with social quality of life. Participation created larger social networks and increased social achievement. Nearly 80% of individuals with SCI indicate that physical activity is important and express interest in maintaining an active lifestyle. However, internal barriers such as motivation and negative perceptions of physical activity have a strong association with exercise participation. Physical and financial barriers including inaccessible facilities, transportation complications, and cost of equipment further limit physical activity participation. Our recent work has further elucidated that barriers to community-based exercise with SCI have been exacerbated by the isolation required to minimize deleterious effects of the COVID-19 pandemic. Psychological and social isolation is increased in individuals with disabilities compared to nondisabled peers. These internal and external barriers highlight health and community inclusion disparities for individuals with SCI. Community inclusion provides people living with SCI equal access and opportunity to healthy living.

While there are numerous psychological and social benefits of exercise for individuals living with SCI, nearly 50% of this population is physically inactive. Tele-interventions have the potential to enhance physical activity participation and community inclusion through reducing barriers such as transportation and cost while improving access for individuals with SCI. Telehealth, or internet-based healthcare services, improve social support and increase cost-effectiveness as compared to standard of care practices. Telehealth has been cited as a successful strategy to mitigate SCI-related healthcare disparities and chronic health condition management. For example, telehealth is an effective intervention to manage pressure ulcer development in SCI. However, these findings are limited to case-based examination of healthcare provider clinical services. Evidence to support tele-interventions that also impact social engagement, such as group tele-exercise, is lacking. One small case-series demonstrated that participants with SCI valued group tele-exercise as a tool to overcome barriers to physical activity participation. Our study will provide evidence of the effectiveness of a community-based tele-exercise intervention for individuals with SCI to promote psychosocial well-being along with enhanced physical activity engagement.

This pragmatic effectiveness study will use a parallel, mixed methods, wait-list control group design. In order to more rigorously investigate the effectiveness of the tele-exercise intervention on psychological and social wellbeing, a subset of participants (n=10) will serve as controls through a waitlist control approach. To achieve this control group, following informed consent, the initial 20 participants will be randomized to immediate intervention group or waitlist control group, with the final 12 participants in the immediate intervention group. As the group tele-exercise intervention encourages participant interaction, the randomization will be in clusters of 6-10 participants. The immediate intervention group will participate in the pre-intervention a semi-structured interview or small focus group and quantitative measures will be obtained. They will participate in the tele-exercise intervention biweekly for 8 weeks with all measures (qualitative and quantitative) obtained at 8-weeks (post-intervention), with leisure time physical activity and quality of life assessed at 16-weeks following initiation of the program. The waitlist control group will complete all quantitative measures as a baseline (baseline-control) and will be instructed to continue their activities as usual, with measures obtained again at 8-weeks (post-control/pre-program). Following the initial 8-week baseline, each waitlist group will participate in pre-intervention semi-structured interview or small focus group with the post-control measures as pre-intervention assessment. They will join the tele-exercise intervention with all measures at 8-weeks (post-intervention) and with leisure time physical activity and quality of life assessed at 16-weeks following initiation of the program. All participants will be provided a logbook with instructions to document physical activity, reflections and associated emotions and behaviors.

Eligibility criteria: Inclusion Criteria:

* report a complete or incomplete SCI of ASIA grade A, B, C, or D
* living with injury at least 12 months
* self-reported ability to elevate shoulder 25% motion
* self-report being between 18-75 years of age
* self report not currently receiving structured rehabilitation,
* cleared by screen by ACSM guidelines for participation
* Internet access to participate in virtual classes

Exclusion Criteria:

* absolute contraindications as identified by ACSM21
* self-report previous hospitalization within a month
* self report active pressure ulcer
* self report recent osteoporotic fracture
* self-report uncorrectable vision loss,
* self report preexisting neurological conditions other than SCI

Primary outcomes:
measure: Change in narrative responses from focus group interviews at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in pain interference on the Spinal Cord Injury Quality of Life - Measurement System-Pain Interference Short Form at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in pain behavior on the Spinal Cord Injury Quality of Life Measurement System-Pain Behavior Short Form at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in self-esteem on the Spinal Cord Injury Quality of Life Measurement System-Self-Esteem Short Form at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in resilience on the Spinal Cord Injury Quality of Life Measurement System-Resilience Short Form at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: 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
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: 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
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: 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
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in sleep disturbance on the General Sleep Disturbance Scale at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 8
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
measure: 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
timeFrame: Pre-Program (0 weeks) and Post-Program (8 weeks)
Secondary outcomes:
measure: Accelerometry
timeFrame: One time collection during intervention
measure: Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) at Week 16
timeFrame: Post-Program (8 weeks) and Retention (16 weeks)
measure: Change in leisure time physical activity behavior on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) at Week 16
timeFrame: Post-Program (8 weeks) and Retention (16 weeks)
measure: Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 16
timeFrame: Post-Program (8 weeks) and Retention (16 weeks)
measure: Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 16
timeFrame: Post-Program (8 weeks) and Retention (16 weeks)
measure: Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in pain interference on the Spinal Cord Injury Quality of Life - Measurement System-Pain Interference Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in pain behavior on the Spinal Cord Injury Quality of Life Measurement System-Pain Behavior Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in self-esteem on the Spinal Cord Injury Quality of Life Measurement System-Self-Esteem Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in resilience on the Spinal Cord Injury Quality of Life Measurement System-Resilience Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in positive affect and well-being on the Spinal Cord Injury Quality of Life Measurement System-Positive Affect and Wellbeing Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in participation in social roles on the Spinal Cord Injury Quality of Life Measurement System-Participation in Social Roles and Activities Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in satisfaction with social roles on the Spinal Cord Injury Quality of Life Measurement System-Satisfaction with Social Roles and Activities Short Form from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in sleep disturbance on the General Sleep Disturbance Scale from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in exercise self-efficacy on the Exercise Self-Efficacy Scale from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
measure: Change in leisure time physical activity behavior on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) from baseline to pre-program (Waitlist control group only)
timeFrame: Baseline to Pre-Program
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Margaret Finley, PhD
role: PRINCIPAL_INVESTIGATOR
References: