Remote and In-person Supervised Exercise in Patients With Knee Osteoarthritis — RISE-KOA  

Knee Osteoarthritis Clinical Trial

Official title: Remote and In-person Supervised Exercise in Patients With Knee Osteoarthritis (RISE-KOA): a Single Blinded, Randomized, Non-inferiority Trial.

Status Recruiting

Clinical Trial Summary

Exercise supervision via telehealth resources is an alternative to the in-person modality with similar therapeutic effectiveness across different clinical profiles. Especially in the context of knee osteoarthritis (OA), exercise is recommended by international guidelines. However, it is necessary to elucidate the comparability of remote and in-person supervised exercise effectiveness for these patients. Therefore, the study's objective is to investigate the responses of a remote compared to the in-person supervised exercise program on patient-reported outcomes measures (PROMs), muscular architecture, and the functional performance of patients with knee OA. Sixty-eight patients with symptomatic and radiographic knee OA will be randomly assigned to remote or in-person exercise programs. The intervention will last 12 weeks, encompassing muscle-strengthening exercises for the lower extremities, with a frequency of twice a week for the initial two weeks and three sessions per week from the third week onwards. Supervision will be conducted remotely via video calls in one group, while the other will receive in-person supervision at a physiotherapy clinic. Program sessions will comprise six exercises. In the first session treatment block, exercises will be guided for the muscle groups of the knee extensors, hip adductors, and plantar flexors, and in the second block, for knee extensors, hip abductors, and knee flexors. After the 12-week supervised treatment period, participants will be encouraged to continue the same exercise program at home without a physiotherapist in the following six weeks. PROMs related to the joint condition will be measured, such as pain, symptoms, daily activities, sports and leisure activities, and quality of life. The psychological domain will also be evaluated, including pain catastrophizing, symptoms of depression, anxiety and stress, and sleep quality. Additionally, measurements of the muscular architecture of the quadriceps femoris, including muscle thickness, pennation angle, fascicle length, and echo intensity, will be taken. Functional performance will be assessed through tests that include the skills of standing and sitting, walking and going up, and down stairs. PROMs will be measured at weeks 0, 6, 12, and 18. Muscular architecture and functional parameters will be measured at weeks 0 and 12. Data analysis will be conducted using Linear Mixed Models, and analysis will be presented by intention to treat and per protocol. The significance level adopted for this study will be α = 0.05.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT06101797
• Study type: Interventional
• Source: Federal University of Pelotas
• Contact: Mauricio Tatsch Ximenes Carvalho, Msc
• Phone: 5555996782793
• Email: carvalhomauricio960@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Completion date: October 31, 2024