Clinical trial NCT07022808: Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury
Official title: Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury, TEEMS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: randomized control trial
spinal cord injury
physical activity
tele-exercise
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group mixed methods randomized control trial comparing participation in the TEEMS program with exercise via asynchronous video library equivalent (control). The use of mixed methods will allow for the integration of quantitative findings with the qualitative, lived perspective of participants to provide a comprehensive analysis of the tele-exercise program outcomes.
Primary purpose: TREATMENT

Brief summary: To achieve our specific aims and hypotheses we will conduct a parallel group mixed methods randomized control trial comparing participation in the TEEMS program with exercise via asynchronous video library equivalent (control). The use of mixed methods will allow for the integration of quantitative findings with the qualitative, lived perspective of participants to provide a comprehensive analysis of the tele-exercise program outcomes. All aspects of the study from recruitment, screening, data collection, tele-exercise delivery and team meetings will be virtual to promote access and inclusion by removing barriers and promoting engagement. This study will compare our live group TEEMS program with individual pre-recorded exercise videos. We created TEEMS with the intention of maximizing exercise independence for participants, which decreases need for caregivers during physical activity. The design and participation in TEEMS is meant to increase personal factors that facilitate participation in exercise. These personal factors include confidence and positive associations with exercise. When these personal factors are targeted, individuals with SCI are more likely to participate in physical activity, which supports overall health and QoL.

Detailed description: Background: Over half of individuals with spinal cord injury (SCI) report no regular physical activity, a cornerstone for independent function and psychosocial health. Studies confirm comparable prevalence and disruptive impact of SCI inactivity/sedentary lifestyle in the civilian and military community, as well as similar barriers to exercise participation. The proposed study will simultaneously address barriers and promote facilitators of physical activity behavior through expert SCI-specific knowledge, peer mentoring, group cohesion, creating autonomy and self-efficacy, mechanisms of engagement that are relevant across both military and civilian sectors.

Hypothesis/Objectives: Our broad research objective is to determine the effectiveness of a novel group exercise program, (Tele Exercise to promote Empowered Movement with Spinal Cord Injury, TEEMS) that will foster the development of lifelong physical activity behavior by enhancing self-efficacy, specifically as it pertains to exercise. This is facilitated through expert knowledge translation with peer interaction and mentoring. We hypothesize that greater improvements in physical activity participation and psychosocial determinants will be found following participation in TEEMS compared to the control group and will be retained at 16-weeks.

Specific Aims: Aim 1-3 will determine if participation in the synchronous TEEMS program improves psychosocial determinants (self-efficacy, outcome expectations, resilience, kinesiophobia, quality of life) of physical activity behavior (weekly minutes by self-report, wearable activity monitor) and physical factors (pain behaviors, mobility and sleep disturbance) compared to an asynchronous video program (control). Narrative accounts will elaborate on quantitative findings of psychosocial impact of TEEMS participation. Aim 4 will integrate quantitative findings with qualitative, narrative themes of participation in TEEMS to allow for a comprehensive understanding of the impact of group tele-exercise participation compared to an asynchronous video program.

Study Design: We will conduct a randomized control trial using a parallel mixed methods design comparing synchronous participation in the TEEMS program with exercise via asynchronous videos (control). Per the mixed methods design the two distinct datasets (quantitative and qualitative) will be independently collected and analyzed in parallel, with the goal of convergent integration. Data will be collected pre-program, post-program (8-weeks) at retention at 16-weeks. Our novel remotely delivered, synchronous tele-exercise program reduces barriers to access and provides peer support in an inclusive SCI-specific program led by experts in adapted exercise and co-led by individuals living with SCI. Our program conceptual framework is Social Cognitive Theory (SCT), which emphasizes that influencing sociostructural factors and personal determinants will impact health behaviors including physical activity. Each class will be recorded and upon request, participants will be provided access if they choose to perform a class independently. The control group will receive a bank of 16 videos from the previous 8-week session of the tele-exercise program, with a goal of completing 2 videos/week. They will be provided with instructions on progression through the videos and as with the intervention group access as well as ability to access if they choose to perform a class independently. The control group will have weekly communication with the investigative team as well as one-on-one sessions with the leader and co-leader at baseline, week 3 and week 6 to discuss progression and received feedback. All research activities (recruitment, enrollment, communication, data collection, intervention) will be conducted remotely through web-enhanced video systems (Zoom).

Eligibility criteria: Inclusion Criteria:

1. at least 12 months post SCI (motor spinal level C5 or below)
2. between 18-75 years of age
3. ability to elevate shoulders \>25% range
4. use assistive technology for mobility
5. not currently receiving structured rehabilitation (i.e. new episode of inpatient or outpatient rehabilitation services to treat a new or exacerbated mobility issue. Individuals attending outpatient services for ongoing wellness reasons are eligible to participate).
6. screened and medically cleared (if appropriate) for participation using the American College of Sports Medicine (ACSM) Preparticipation Health Screening Tool. The ACSM Health Screen helps to determine if an individuals should seek a medical referral prior to participation in exercise. The guideline for the screening are based on (1) current exercise participation, (2) history and symptoms of cardiovascular, metabolic, or renal disease, and (3) desired exercise intensity. The algorithm is based on risk stratification and minimizing the barriers of exercise participation by decreasing the number of unnecessary medical referrals.

   For this study and the safety of participants, those who need a medical referral based on the ACSM preparticipation health screen will be required to provide documentation of medical clearance from their primary medical provider prior to study participation. Dr. York will review screening information and medical clearances to ensure safe inclusion.
7. internet access to attend synchronous exercise classes

Exclusion Criteria:

1. Known or suggestive cardiovascular, metabolic, and/or renal disease and/or presence of absolute or relative contraindications to exercise participation that is considered unsafe by their medical team
2. self-report previous hospitalization within a month,
3. self report active pressure injury
4. self report recent osteoporotic fracture
5. self-report uncorrectable vision loss,
6. self-report preexisting neurological conditions other than SCI

Primary outcomes:
measure: Exercise Self Efficacy
timeFrame: at baseline (enrollment), 8-weeks, 16-weeks
measure: Exercise Outcome Expectations
timeFrame: baseline (enrollment), 8-weeks and 16-weeks
measure: Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI)
timeFrame: baseline (enrollment), one -week, 8-weeks, 16-weeks
measure: Physical Activity Measure.
timeFrame: baseline (enrollment), 8-weeks, 16-weeks
measure: Subjective Quality of Life Questionnaire (SQoL)
timeFrame: baseline (enrollment), 8-weeks, 16-weeks
measure: Qualitative data
timeFrame: baseline, 8-weeks
Secondary outcomes:
measure: Loneliness (UCLA Loneliness Scale) -
timeFrame: baseline (enrollment), 8-weeks
measure: Pain phenomena (SCIQOL-PP)
timeFrame: baseline (enrollment), 8-weeks
measure: Self-esteem (SCI-QOL-SE)
timeFrame: baseline (enrollment), 8-weeks
measure: Depression (SCI-QOL-DEPR)
timeFrame: baseline (enrollment), 8-weeks
measure: Resilience (SCI-QOL-RES)
timeFrame: baseline (enrollment), 8-weeks
measure: Participation in Social Roles and Activity (SCI-QOL-PSR)
timeFrame: baseline (enrollment), 8-weeks
measure: Satisfaction with Social Roles and Activity (SCI-QOL-SSR)
timeFrame: baseline (enrollment), 8-weeks
measure: General Sleep Disturbance Scale
timeFrame: baseline (enrollment), 8-weeks
Other outcomes:
Locations:
city: Phildelphia
country: United States
facility: Drexel University Health Science Building
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Margaret Finley, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drexel University
name: Laura Baehr, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: