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Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial

BACKGROUND: Knee trauma permanently elevates one’s risk for knee osteoarthritis. Despite this, people at-risk of post-traumatic knee osteoarthritis rarely seek or receive care, and accessible and efficacious interventions to promote knee health after injury are lacking. Exercise can ameliorate some...

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Autores principales: Whittaker, Jackie L., Truong, Linda K., Losciale, Justin M., Silvester-Lee, Trish, Miciak, Maxi, Pajkic, Andrea, Le, Christina Y., Hoens, Alison M., Mosewich, Amber, Hunt, Michael A., Li, Linda C., Roos, Ewa M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8790851/
https://www.ncbi.nlm.nih.gov/pubmed/35078446
http://dx.doi.org/10.1186/s12891-022-05019-z
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author Whittaker, Jackie L.
Truong, Linda K.
Losciale, Justin M.
Silvester-Lee, Trish
Miciak, Maxi
Pajkic, Andrea
Le, Christina Y.
Hoens, Alison M.
Mosewich, Amber
Hunt, Michael A.
Li, Linda C.
Roos, Ewa M.
author_facet Whittaker, Jackie L.
Truong, Linda K.
Losciale, Justin M.
Silvester-Lee, Trish
Miciak, Maxi
Pajkic, Andrea
Le, Christina Y.
Hoens, Alison M.
Mosewich, Amber
Hunt, Michael A.
Li, Linda C.
Roos, Ewa M.
author_sort Whittaker, Jackie L.
collection PubMed
description BACKGROUND: Knee trauma permanently elevates one’s risk for knee osteoarthritis. Despite this, people at-risk of post-traumatic knee osteoarthritis rarely seek or receive care, and accessible and efficacious interventions to promote knee health after injury are lacking. Exercise can ameliorate some mechanisms and independent risk factors for osteoarthritis and, education and action-planning improve adherence to exercise and promote healthy behaviours. METHODS: To assess the efficacy of a virtually-delivered, physiotherapist-guided exercise-based program (SOAR) to improve knee health in persons discharged from care after an activity-related knee injury, 70 people (16–35 years of age, 12–48 months post-injury) in Vancouver Canada will be recruited for a two-arm step-wedged assessor-blinded delayed-control randomized trial. Participants will be randomly allocated to receive the intervention immediately or after a 10-week delay. The program consists of 1) one-time Knee Camp (group education, 1:1 individualized exercise and activity goal-setting); 2) weekly individualized home-based exercise and activity program with tracking, and; 3) weekly 1:1 physiotherapy-guided action-planning with optional group exercise class. Outcomes will be measured at baseline, 9- (primary endpoint), and 18-weeks. The primary outcome is 9-week change in knee extension strength (normalized peak concentric torque; isokinetic dynamometer). Secondary outcomes include 9-week change in moderate-to-vigorous physical activity (accelerometer) and self-reported knee-related quality-of-life (Knee injury and OA Outcome Score subscale) and self-efficacy (Knee Self Efficacy Scale). Exploratory outcomes include 18-week change in primary and secondary outcomes, and 9- and 18- week change in other components of knee extensor and flexor muscle function, hop function, and self-reported symptoms, function, physical activity, social support, perceived self-care and kinesiophobia. Secondary study objectives will assess the feasibility of a future hybrid effectiveness-implementation trial protocol, determine the optimal intervention length, and explore stakeholder experiences. DISCUSSION: This study will assess the efficacy of a novel, virtually-delivered, physiotherapist-guided exercise-based program to optimize knee health in persons at increased risk of osteoarthritis due to a past knee injury. Findings will provide valuable information to inform the management of osteoarthritis risk after knee trauma and the conduct of a future effectiveness-implementation trial. TRIAL REGISTRATION: Clinicaltrials.gov reference: NTC04956393. Registered August 5, 2021, https://clinicaltrials.gov/ct2/show/NCT04956393?term=SOAR&cond=osteoarthritis&cntry=CA&city=Vancouver&draw=2&rank=1 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-022-05019-z.
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spelling pubmed-87908512022-01-26 Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial Whittaker, Jackie L. Truong, Linda K. Losciale, Justin M. Silvester-Lee, Trish Miciak, Maxi Pajkic, Andrea Le, Christina Y. Hoens, Alison M. Mosewich, Amber Hunt, Michael A. Li, Linda C. Roos, Ewa M. BMC Musculoskelet Disord Study Protocol BACKGROUND: Knee trauma permanently elevates one’s risk for knee osteoarthritis. Despite this, people at-risk of post-traumatic knee osteoarthritis rarely seek or receive care, and accessible and efficacious interventions to promote knee health after injury are lacking. Exercise can ameliorate some mechanisms and independent risk factors for osteoarthritis and, education and action-planning improve adherence to exercise and promote healthy behaviours. METHODS: To assess the efficacy of a virtually-delivered, physiotherapist-guided exercise-based program (SOAR) to improve knee health in persons discharged from care after an activity-related knee injury, 70 people (16–35 years of age, 12–48 months post-injury) in Vancouver Canada will be recruited for a two-arm step-wedged assessor-blinded delayed-control randomized trial. Participants will be randomly allocated to receive the intervention immediately or after a 10-week delay. The program consists of 1) one-time Knee Camp (group education, 1:1 individualized exercise and activity goal-setting); 2) weekly individualized home-based exercise and activity program with tracking, and; 3) weekly 1:1 physiotherapy-guided action-planning with optional group exercise class. Outcomes will be measured at baseline, 9- (primary endpoint), and 18-weeks. The primary outcome is 9-week change in knee extension strength (normalized peak concentric torque; isokinetic dynamometer). Secondary outcomes include 9-week change in moderate-to-vigorous physical activity (accelerometer) and self-reported knee-related quality-of-life (Knee injury and OA Outcome Score subscale) and self-efficacy (Knee Self Efficacy Scale). Exploratory outcomes include 18-week change in primary and secondary outcomes, and 9- and 18- week change in other components of knee extensor and flexor muscle function, hop function, and self-reported symptoms, function, physical activity, social support, perceived self-care and kinesiophobia. Secondary study objectives will assess the feasibility of a future hybrid effectiveness-implementation trial protocol, determine the optimal intervention length, and explore stakeholder experiences. DISCUSSION: This study will assess the efficacy of a novel, virtually-delivered, physiotherapist-guided exercise-based program to optimize knee health in persons at increased risk of osteoarthritis due to a past knee injury. Findings will provide valuable information to inform the management of osteoarthritis risk after knee trauma and the conduct of a future effectiveness-implementation trial. TRIAL REGISTRATION: Clinicaltrials.gov reference: NTC04956393. Registered August 5, 2021, https://clinicaltrials.gov/ct2/show/NCT04956393?term=SOAR&cond=osteoarthritis&cntry=CA&city=Vancouver&draw=2&rank=1 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-022-05019-z. BioMed Central 2022-01-25 /pmc/articles/PMC8790851/ /pubmed/35078446 http://dx.doi.org/10.1186/s12891-022-05019-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Whittaker, Jackie L.
Truong, Linda K.
Losciale, Justin M.
Silvester-Lee, Trish
Miciak, Maxi
Pajkic, Andrea
Le, Christina Y.
Hoens, Alison M.
Mosewich, Amber
Hunt, Michael A.
Li, Linda C.
Roos, Ewa M.
Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial
title Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial
title_full Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial
title_fullStr Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial
title_full_unstemmed Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial
title_short Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial
title_sort efficacy of the soar knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8790851/
https://www.ncbi.nlm.nih.gov/pubmed/35078446
http://dx.doi.org/10.1186/s12891-022-05019-z
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