NCT06101797: RISE-KOA

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

Completed NA Last updated 5 September 2025

What this trial tests

NA trial testing Remote supervised exercise group in Knee Osteoarthritis in 48 participants. Completed in 8 March 2025.

Timeline

4 December 2023

Primary endpoint
15 January 2025

8 March 2025

Quick facts

Lead sponsor	Federal University of Pelotas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	4 December 2023
Primary completion	15 January 2025
Estimated completion	8 March 2025
Sites	1 location across Brazil

Drugs / interventions tested

• Remote supervised exercise group
• In-person supervised exercise group

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Federal University of Pelotas

Who can join

Adults 45 to 80, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Forty-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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis (RISE-KOA): study protocol for a non-inferiority randomized controlled trial.
   Carvalho MTX, Alberton CL. · · 2025 · PMID 40394687 · DOI 10.1186/s13063-025-08884-w
2. Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis (RISE-KOA): study protocol for a non-inferiority randomized controlled trial.
   Carvalho MTX, Alberton CL. · · 2024 · DOI 10.21203/rs.3.rs-4237844/v1