Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury

NCT07022808 | Not Yet Recruiting DMC

• 2 other identifiers: SC40042_RCT_TEEMSHT94252510367
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

randomized control trial; spinal cord injury; physical activity; tele-exercise

Outcome Measures

Primary Outcomes (6)

• 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.

  at baseline (enrollment), 8-weeks, 16-weeks

• 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

  baseline (enrollment), 8-weeks and 16-weeks

• 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.

  baseline (enrollment), one -week, 8-weeks, 16-weeks

• 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).

  baseline (enrollment), 8-weeks, 16-weeks

• Subjective Quality of Life Questionnaire (SQoL)

  This questionnaire is a global measure of subjective perception of QoL. The scale is a Likert-type scale measuring satisfaction with life as a whole: Participants are asked to take everything in their life into account and rate it on an ordinal scale from 1 (life is very distressing; it's hard to imagine how it could get much worse) to 7 (life is great; it's hard to imagine how it could get much better).

  baseline (enrollment), 8-weeks, 16-weeks

• Qualitative data

  Focus group data collection will be conducted via secure web-based video conferencing platform (Zoom). Data will be obtained at pre-program and post-program (8-weeks). All participants will join focus group interviews of 5-8 individuals that will take approximately 60 minutes pre (baseline) and post- program (8-weeks). Focus groups will be facilitated by a trained team member and co- facilitated by a lived experience class co-instructor . The open-ended guiding questions will be grounded by the numeric outcomes corresponding to measurement constructs and our previous work.

  baseline, 8-weeks

Secondary Outcomes (8)

• Loneliness (UCLA Loneliness Scale) -

  baseline (enrollment), 8-weeks

• Pain phenomena (SCIQOL-PP)

  baseline (enrollment), 8-weeks

• Self-esteem (SCI-QOL-SE)

  baseline (enrollment), 8-weeks

• Depression (SCI-QOL-DEPR)

  baseline (enrollment), 8-weeks

• Resilience (SCI-QOL-RES)

  baseline (enrollment), 8-weeks

Study Arms (2)

Synchronous Group Exercise

EXPERIMENTAL

All participants will participate in the TEEMS biweekly for 8 weeks (synchronous intervention or asynchronous video library). Participants 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 u

Other: Synchronous Group exercise

Asynchronous Exercise

ACTIVE COMPARATOR

The asynchronous control condition will be delivered using a private Youtube playlist. The asynchronous group will be provided with 2 recorded TEEMS videos weekly that align with the synchronous group sessions, building a 16 video library. Participants will participate in the TEEMS biweekly for 8 weeks (synchronous intervention). The asynchronous group will perform sessions 2 times per week. The sessions will be 60-minutes total, including 45-minutes of physical activity.

Other: Asynchronous exercise (Control)

Interventions

Synchronous Group exercise OTHER

Participants 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.

Synchronous Group Exercise

Asynchronous exercise (Control) OTHER

Participants 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.

Asynchronous Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).
• 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.
• internet access to attend synchronous exercise classes

You may not qualify if:

• 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
• self-report uncorrectable vision loss,
• self-report preexisting neurological conditions other than SCI

Sponsors & Collaborators

• Drexel University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Drexel University Health Science Building

Phildelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Margaret Finley, PT, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

• Laura Baehr, PT, DPT, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARGARET FINLEY, PT, PhD

CONTACT

4107462112; SCIexerciseonline@drexel.edu

Laura Baehr, PT, DPT, PhD

CONTACT

SCIexerciseonline@drexel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: biostatistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 15, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the conclusion of the research, quantitative data will be made available through the Open Data Commons for Spinal Cord Injury (ODC-SCI). We will make our data available on the public site upon submission of a pre-print or publication of the study in a peer-reviewed journal. ODC-SCI fully supports peer review by providing a private space which can be accessed anonymously by peer reviewer issued provisional DOIs. These can be used to hold the data under embargo before release. If the study is not successful and/or we do not publish the study, we will still make our negative data available through ODC-SCI.
• Access Criteria: We will make our data available through ODC-SCI under an open CC-BY license. The ODC-SCI is compliant with requirements for FAIR and trustworthy repositories established by NIH, NLM and journals. ODC-SCI runs an open-source cloud- based platform optimized for managing and sharing multimodal data

Locations

US (1)