Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury
ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDrexel University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
at least 12 months post SCI (motor spinal level C5 or below)
between 18-75 years of age
ability to elevate shoulders >25% range
use assistive technology for mobility
Disqualifiers
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
self-report previous hospitalization within a month,
self report active pressure injury
self report recent osteoporotic fracture
Trial design
Design model
Parallel
Treatments tested in this trial
Synchronous Group exercise
Other interventionParticipants will participate in the TEEMS biweekly for 8 weeks (synchronous intervention). The synchronous group will attend sessions 2 times per week, with all sessions recorded. The sessions will be 60-minutes total, including 45-minutes of physical activity. Recorded sessions will be made available for participants to use on their own at the end of each week, building a video of 16 videos. The program will be taught by a rehabilitation clinician with expertise in SCI and adapted exercise while our co-instructor will offer peer guidance and demonstrate lived translation of movement with an SCI. Class will take place over a web-based platform (such as Zoom).TEEMS instructors also orient participants to the Borg Rate of Perceived Exertion (RPE, 6-20 scale) to be used as an self-exertion check throughout class and to be recorded in a provided logbook. RPE is used as a self-assessment of moderate-vigorous intensity exercise.
Asynchronous exercise (Control)
Other interventionParticipants will participate in the TEEMS biweekly for 8 weeks (asynchronous video library). The asynchronous, control group will be provided with 2 recorded videos weekly that align with the synchronous group sessions, building a 16 video library as well. The sessions will be 60-minutes total, including 45-minutes of physical activity. The program will be taught by a rehabilitation clinician with expertise in SCI and adapted exercise while our co-instructor will offer peer guidance and demonstrate lived translation of movement with an SCI. Class will take place over a web-based platform (such as Zoom).TEEMS instructors also orient participants to the Borg Rate of Perceived Exertion (RPE, 6-20 scale) to be used as an self-exertion check throughout class and to be recorded in a provided logbook. RPE is used as a self-assessment of moderate-vigorous intensity exercise.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Synchronous Group ExerciseExperimental treatment 1 intervention
Group B: Asynchronous ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Exercise Self Efficacy
The SCI Exercise Self-efficacy Scale (ESES).This self-report measures the construct of self-efficacy, or personal beliefs in one's capabilities relating to exercise participation in individuals with SCI. Self-efficacy is cited as the most critical personal factor to behavior change. This outcome demonstrates reliability and high internal consistency.
Time frame
at baseline (enrollment), 8-weeks, 16-weeks2
Exercise Outcome Expectations
The Multidimensional Outcome Expectations for Exercise Scale (MOEES). This self-report measure addresses physical, social, and self-evaluative components of outcome expectations, another critical element needed for health behavior change. This tool also demonstrates high internal consistency and validity
Time frame
baseline (enrollment), 8-weeks and 16-weeks3
Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI)
The Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) is an SCI-specific, self-report measure of leisure-time physical activity that assesses minutes of mild, moderate, and heavy intensity leisure-time physical activity performed over the previous 7-days. Test-retest reliability and criterion validity of the LTPAQ-SCI has been established. The LTPAQ will be obtained an additional time following participation in the first tele-exercise class.
Time frame
baseline (enrollment), one -week, 8-weeks, 16-weeks4
Physical Activity Measure.
Physical Activity monitoring: To assess physical activity engagement, mobility function monitoring will be performed by using an activity monitor (GENEActiv) placed on the non-dominant wrist of the individual over a duration of 7 days (matching the duration of the self-report LTPAQ).
Time frame
baseline (enrollment), 8-weeks, 16-weeksSecondary outcomes
1
Loneliness (UCLA Loneliness Scale) -
Loneliness (UCLA Loneliness Scale) - This 20-item measure assesses constructs of loneliness including interpersonal relationships, health, and wellbeing.
Time frame
baseline (enrollment), 8-weeks2
Pain phenomena (SCIQOL-PP)
Pain interference and Pain Behavior10 Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories. The SCIQOL pain phenomena (pain behavior and pain interference) representing the domain of physical health will be a primary measure. SCIQOL Pain Interference short form (10 items) and the SCIQOL Pain Behavior scale (7 items) are versions of the PROMIS Pain Interference and Pain Behavior item banks, respectively, that have been optimized for individuals with SCI.
Time frame
baseline (enrollment), 8-weeks3
Self-esteem (SCI-QOL-SE)
Self-esteem (SCI-QOL-SE)- The Self-Esteem bank of 8 items assesses emotional, evaluative, and cognitive perceptions of personal competence and worth. This self-evaluation provides a reference by which to compare oneself to relevant others in social and socially competitive situations
Time frame
baseline (enrollment), 8-weeks4
Depression (SCI-QOL-DEPR)
Depression (SCI-QOL-DEPR)6-This 10-item short form contains items addressing despair and/or a loss of interest in things as well as feelings of hopelessness, helplessness, and worthlessness the individual has experienced in the past 7 days.
Time frame
baseline (enrollment), 8-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Drexel University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov