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NCT05360719 · ClinicalTrials.gov registry record · NA

Integrated Tele-exercise for Individuals With Spinal Cord Injury

A NA study of Spinal Cord Injury, sponsored by Drexel University.

Active
Registry status
NA
Development phase
35
Enrollment target
1
Study location

NCT05360719 is a NA study of Spinal Cord Injury that is active but no longer recruiting, run by Drexel University. The registered enrollment target is 35 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05360719, a NA study of Spinal Cord Injury, is active but no longer recruiting, sponsored by Drexel University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
35 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • BEHAVIORAL Group tele-exercise

Study Locations (1)

Pennsylvania

  • Drexel University - Philadelphia

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2022-04-30
Est. Completion 2026-05-31
Phase NA

Sponsor

Drexel University

92 total trials

What the Registry Record Tells You About NCT05360719

The ClinicalTrials.gov registry entry for NCT05360719 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (59% lower). The listed sponsor is Drexel University, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 1 intervention - of which Group tele-exercise is the first listed.

NCT05360719 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05360719 about?

NCT05360719 is a clinical study titled "Integrated Tele-exercise for Individuals With Spinal Cord Injury". 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, ...

What is the current status of trial NCT05360719?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 35 participants. The study started on 2022-04-30. Estimated completion is 2026-05-31.

What conditions does trial NCT05360719 study?

This clinical trial studies the following conditions: Spinal Cord Injury.

What interventions are being tested in trial NCT05360719?

The interventions under investigation include: Group tele-exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT05360719?

This trial is sponsored by Drexel University, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05360719 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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