Integrated Tele-exercise for Individuals With Spinal Cord Injury

NCT05360719 | Active Not Recruiting

• 1 other identifier: CHNF865512-PADoH
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

physical activity; group online exercise

Outcome Measures

Primary Outcomes (14)

• Change in narrative responses from focus group interviews at Week 8

  Semi-structured interviews or small tele-focus groups of 3-5 individuals that will take 60 minutes

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) at Week 8

  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). Test-retest reliability is high (91% agreement), and this questionnaire is validated with the SCI population.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in pain interference on the Spinal Cord Injury Quality of Life - Measurement System-Pain Interference Short Form at Week 8

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Pain Interference short form is comprised of 10 items, asking participants to rate their pain interference on an ordinal scale from 1 (not at all) to 5 (very much) where a higher sum score represents greater pain interference over the previous 7 days.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in pain behavior on the Spinal Cord Injury Quality of Life Measurement System-Pain Behavior Short Form at Week 8

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Pain Behavior short form is comprised of 7 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) for questions 1-3 and from 1 (had no pain) to 6 (always) in questions 4-7 where a higher sum score represents greater pain behavior over the previous 7 days.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in self-esteem on the Spinal Cord Injury Quality of Life Measurement System-Self-Esteem Short Form at Week 8

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Self-Esteem short form is comprised of 8 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents decreased self-esteem with SCI.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form at Week 8

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Depression short form is comprised of 10 items, asking participants to rate their depressive symptoms on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased despair and/or loss of interest in things with SCI.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in resilience on the Spinal Cord Injury Quality of Life Measurement System-Resilience Short Form at Week 8

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Resilience short form is comprised of 8 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased resilience with SCI.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• 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

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Positive Affect and Wellbeing short form is comprised of 10 items, asking participants to rate their overall sense of purpose, wellbeing, and life satisfaction on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased positive affect and wellbeing with SCI.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• 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

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Participation in Social Roles and Activities short form is comprised of 10 items, asking participants to rate their current involvement in social roles on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased participation in social roles and activities with SCI.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• 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

  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 of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Participation in Social Roles and Activities short form is comprised of 10 items, asking participants to rate their current involvement in social roles on an ordinal scale from 1 (not at all) to 5 (very much) where a higher sum score represents increased satisfaction with social roles and activities with SCI.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in sleep disturbance on the General Sleep Disturbance Scale at Week 8

  The GSDS is a 21-item scale was designed to evaluate the incidence and nature of sleep disturbances. Questions pertain to a variety of general sleep issues, including problems initiating sleep, waking up during sleep, waking too early from sleep, quality of sleep, quantity of sleep, fatigue and alertness at work, and the use of substances to induce sleep. Internal consistency for the full scale has been shown to be 0.88. The GSDS queries respondents regarding the frequency with which they've experienced certain sleep difficulties within the previous week. Respondents use an eight-point, Likert-type scale ranging from 0 (meaning "never") to 7 ("every day") to respond to each item where higher sum score represents increased general sleep disturbance.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 8

  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. Respondents answer using a 4-point Likert-type scale ranging from 1 (not at all true) to 4 (exactly true) to respond to 10-items where higher sum score represents increased exercise self-efficacy with SCI.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 8

  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. Respondents answer using a 5-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree) to respond to 15-items where higher sum score represents increased positive exercise outcome expectations.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

• 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

  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. Total number of exercise minutes over the previous 7-days is calculated.

  Pre-Program (0 weeks) and Post-Program (8 weeks)

Secondary Outcomes (18)

• Accelerometry

  One time collection during intervention

• Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) at Week 16

  Post-Program (8 weeks) and Retention (16 weeks)

• 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

  Post-Program (8 weeks) and Retention (16 weeks)

• Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 16

  Post-Program (8 weeks) and Retention (16 weeks)

• Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 16

  Post-Program (8 weeks) and Retention (16 weeks)

Study Arms (2)

Group Tele-exercise Class

EXPERIMENTAL

Volunteers will be asked to participate in the group online exercise class 2 times per week for 8 weeks. Each activity session will last about 60 minutes and will focus on mind-body practices, tailored to physical and emotional needs of individuals with SCI. Class will be taught by a physical therapist who is an experienced community exercise instructor. Class will be co-led by a person who is living with SCI (one of our community partners). Classes will take place over a secure virtual platform (Zoom). Before beginning and after completion of the program, participants will be asked to participate in small group interviews to share expectations and experiences of the study

Behavioral: Group tele-exercise

Waitlist Control

OTHER

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.

Behavioral: Group tele-exercise

Interventions

Group tele-exercise BEHAVIORAL

This tele-exercise class will be tailored to the physical and emotional needs of individuals with SCI based on results of our feasibility study, the initial emergent themes from qualitative data collection in this study, and input from our co-leader with lived experience (examples: seated exercise to accommodate wheelchair users, active co-leader with SCI).The research clinician will lead the instruction of each class while our co-leader will model movements alongside her and offer tailored modifications as needed. Each 45-minute class provides a comprehensive fitness experience to maximize functional independence and improve global physical activity engagement. Elements incorporated into each class session include a collective check-in and breathing meditation, postural control, trunk and shoulder strength, cardiovascular fitness, and body awareness.

Group Tele-exercise Class; Waitlist Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Craig H. Neilsen Foundation: collaborator
• Pennsylvania Department of Health: collaborator
• Drexel University: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (1)

• Baehr LA, Hiremath SV, Bruneau M Jr, Chiarello LA, Kaimal G, Newton R, Finley M. Effect of Tele-exercise to Promote Empowered Movement for Individuals With Spinal Cord Injury (TEEMS) Program on Physical Activity Determinants and Behavior: A Mixed Methods Assessment. Arch Phys Med Rehabil. 2024 Jan;105(1):101-111. doi: 10.1016/j.apmr.2023.08.019. Epub 2023 Sep 9.

  PMID: 37678447 DERIVED

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, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor collecting data will be masked to group (wait list control vs immediate group)
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: waitlist control repeated measures

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 4, 2022
• Study Start: April 30, 2022
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)