The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury
Abstract Background Many people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and function in people with SCI. The purpose of this study is to test the effect...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2021-08-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05474-4 |
| _version_ | 1818611633327439872 |
|---|---|
| author | Hui-Ju Young Tapan Mehta Yumi Kim Sangeetha Padalabalanarayanan Chia-Ying Chiu James H. Rimmer Mohanraj Thirumalai |
| author_facet | Hui-Ju Young Tapan Mehta Yumi Kim Sangeetha Padalabalanarayanan Chia-Ying Chiu James H. Rimmer Mohanraj Thirumalai |
| author_sort | Hui-Ju Young |
| collection | DOAJ |
| description | Abstract Background Many people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and function in people with SCI. The purpose of this study is to test the effectiveness of two remotely delivered exercise programs for people with SCI. Methods The Spinal Cord Injury Program in Exercise (SCIPE) study is a three-arm adaptive randomized controlled trial examining two 8-week teleexercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), compared to Attention Control (AC) in 327 adults with SCI. The primary outcome is change in physical activity level at post 8-week intervention. The study contains two interim analyses. The first interim analysis will assess feasibility metrics of the protocol after 36 participants complete the 8-week intervention period. The second interim analysis will examine two effectiveness comparisons: SET vs. AC and M2M vs AC, after 165 participants complete the intervention period. Early termination of the intervention arm(s) will take place when non-significant findings are found in the corresponding intervention(s). Incorporation of such interim analysis enhances trial efficiency by dropping the intervention(s) that deemed ineffective. It provides ethical benefits and allows allocation of additional resources to explore the effective intervention(s). Discussion Delivery of teleexercise programs may be an effective strategy for addressing transportation barrier to exercise resources and increasing physical activity level and quality of life in people with SCI. Trial registration ClinicalTrials.gov Identifier NCT03925077 . Registered trial name: Spinal Cord Injury Program in Exercise (SCIPE). Registered on April 23rd, 2019. |
| first_indexed | 2024-12-16T15:33:26Z |
| format | Article |
| id | doaj.art-c29514477fe94d828a93e460da7d2107 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-16T15:33:26Z |
| publishDate | 2021-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c29514477fe94d828a93e460da7d21072022-12-21T22:26:16ZengBMCTrials1745-62152021-08-0122111110.1186/s13063-021-05474-4The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injuryHui-Ju Young0Tapan Mehta1Yumi Kim2Sangeetha Padalabalanarayanan3Chia-Ying Chiu4James H. Rimmer5Mohanraj Thirumalai6UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at BirminghamUAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at BirminghamUAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at BirminghamUAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at BirminghamDepartment of Health Services Administration, School of Health Professions, University of Alabama at BirminghamUAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at BirminghamUAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at BirminghamAbstract Background Many people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and function in people with SCI. The purpose of this study is to test the effectiveness of two remotely delivered exercise programs for people with SCI. Methods The Spinal Cord Injury Program in Exercise (SCIPE) study is a three-arm adaptive randomized controlled trial examining two 8-week teleexercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), compared to Attention Control (AC) in 327 adults with SCI. The primary outcome is change in physical activity level at post 8-week intervention. The study contains two interim analyses. The first interim analysis will assess feasibility metrics of the protocol after 36 participants complete the 8-week intervention period. The second interim analysis will examine two effectiveness comparisons: SET vs. AC and M2M vs AC, after 165 participants complete the intervention period. Early termination of the intervention arm(s) will take place when non-significant findings are found in the corresponding intervention(s). Incorporation of such interim analysis enhances trial efficiency by dropping the intervention(s) that deemed ineffective. It provides ethical benefits and allows allocation of additional resources to explore the effective intervention(s). Discussion Delivery of teleexercise programs may be an effective strategy for addressing transportation barrier to exercise resources and increasing physical activity level and quality of life in people with SCI. Trial registration ClinicalTrials.gov Identifier NCT03925077 . Registered trial name: Spinal Cord Injury Program in Exercise (SCIPE). Registered on April 23rd, 2019.https://doi.org/10.1186/s13063-021-05474-4Spinal cord injuryPhysical activityDisabilityTeleexerciseQuality of life |
| spellingShingle | Hui-Ju Young Tapan Mehta Yumi Kim Sangeetha Padalabalanarayanan Chia-Ying Chiu James H. Rimmer Mohanraj Thirumalai The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury Trials Spinal cord injury Physical activity Disability Teleexercise Quality of life |
| title | The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury |
| title_full | The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury |
| title_fullStr | The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury |
| title_full_unstemmed | The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury |
| title_short | The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury |
| title_sort | spinal cord injury program in exercise scipe study study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury |
| topic | Spinal cord injury Physical activity Disability Teleexercise Quality of life |
| url | https://doi.org/10.1186/s13063-021-05474-4 |
| work_keys_str_mv | AT huijuyoung thespinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT tapanmehta thespinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT yumikim thespinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT sangeethapadalabalanarayanan thespinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT chiayingchiu thespinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT jameshrimmer thespinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT mohanrajthirumalai thespinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT huijuyoung spinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT tapanmehta spinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT yumikim spinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT sangeethapadalabalanarayanan spinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT chiayingchiu spinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT jameshrimmer spinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury AT mohanrajthirumalai spinalcordinjuryprograminexercisescipestudystudyprotocolforarandomizedcontrolledtrialevaluatingteleexerciseprogramsforpeoplewithspinalcordinjury |