Trials · 2025
Evaluating the comparative efficacy of leg cycle ergometry exercise versus conventional physiotherapy on scar healing, muscle strength, functional capacity, and quality of life in coronary artery bypass graft subjects with saphenous vein graft in phase 1: a protocol for randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Vinerkar Deepali, Vardhan Vishnu
Аннотация
BACKGROUND: Coronary artery bypass grafting (CABG) is a common surgical treatment for coronary artery disease. The saphenous vein's advantageous anatomical features make it a popular choice for graft vessels. However, saphenous vein harvesting often results in lower limb complications such as edema, poor scar healing, pain, and reduced functional mobility. These issues can delay recovery and diminish quality of life. Early rehabilitation using leg cycle ergometry may improve outcomes, but comparative evidence with conventional physiotherapy in Phase I post-CABG care is limited.
AIM: To determine the relative benefits of leg cycle ergometry training for CABG patients with saphenous vein graft in phase 1 in terms of scar healing, muscle strength, functional ability, and quality of life.
OBJECTIVES: To evaluate the comparative efficacy of leg cycle ergometry exercise versus conventional physiotherapy on scar healing, muscle strength, functional capacity, and quality of life in CABG subjects with saphenous vein grafts during Phase I rehabilitation.
METHODS: A randomized controlled trial will be conducted at Shalini Tai Meghe Super Speciality Centre with 70 CABG patients aged 45-65 years. Participants will be randomly allocated to Group A (conventional physiotherapy) and Group B (leg cycle ergometry with physiotherapy) for a 10-day intervention. Outcome measures include the Vancouver Scar Scale, Manual Muscle Testing, 6-Minute Walk Test, and Patient Health Questionnaire-9 (PHQ-9). Data will be analysed using the Mann-Whitney U test and the Wilcoxon signed-rank test; p<0.05 was deemed statistically significant.
RESULTS: As this is a study protocol, no results are available yet. It is hypothesized that leg cycle ergometry, when added to conventional physiotherapy, will lead to greater improvements in scar healing, lower limb strength, functional capacity, and short-term quality of life during Phase I cardiac rehabilitation following CABG surgery.
TRIAL REGISTRATION: Clinical Trial Registry-India (CTRI/2025/03/084291). Registered on 15 April 2025.
AIM: To determine the relative benefits of leg cycle ergometry training for CABG patients with saphenous vein graft in phase 1 in terms of scar healing, muscle strength, functional ability, and quality of life.
OBJECTIVES: To evaluate the comparative efficacy of leg cycle ergometry exercise versus conventional physiotherapy on scar healing, muscle strength, functional capacity, and quality of life in CABG subjects with saphenous vein grafts during Phase I rehabilitation.
METHODS: A randomized controlled trial will be conducted at Shalini Tai Meghe Super Speciality Centre with 70 CABG patients aged 45-65 years. Participants will be randomly allocated to Group A (conventional physiotherapy) and Group B (leg cycle ergometry with physiotherapy) for a 10-day intervention. Outcome measures include the Vancouver Scar Scale, Manual Muscle Testing, 6-Minute Walk Test, and Patient Health Questionnaire-9 (PHQ-9). Data will be analysed using the Mann-Whitney U test and the Wilcoxon signed-rank test; p<0.05 was deemed statistically significant.
RESULTS: As this is a study protocol, no results are available yet. It is hypothesized that leg cycle ergometry, when added to conventional physiotherapy, will lead to greater improvements in scar healing, lower limb strength, functional capacity, and short-term quality of life during Phase I cardiac rehabilitation following CABG surgery.
TRIAL REGISTRATION: Clinical Trial Registry-India (CTRI/2025/03/084291). Registered on 15 April 2025.