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

NCT ID: NCT06101797

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2025-03-08

Brief 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. 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Remote supervised exercise group

The intervention will last 12 weeks and consist of muscle-strengthening exercises for the lower extremities supervised remotely by video call.

Group Type: EXPERIMENTAL

Remote supervised exercise group

Intervention Type: OTHER

The exercise protocol for this group consists of individualized muscle-strengthening exercises for the lower extremities supervised by video call. The intervention will occur 2-3 times per week, each lasting approximately 40 minutes. The exercise protocol will consist of six muscle-strengthening exercises for the lower extremities, which will be guided, alternating muscle groups. In the first two weeks of treatment, exercise intensity will be monitored for participants to complete two sets of 8-12 repetitions in dynamic exercises. From the third week onward, participants will progress to one additional set. Adjustments to weight-bearing, the external load imposed by the elastic band, and exercise position throughout the protocol will be performed to maintain the participant's level of effort. After supervised exercise treatment, patients will be encouraged to maintain an exercise routine with the same exercise protocol, however, without physiotherapy supervision.

In-person supervised exercise group

The intervention will last 12 weeks and consist of muscle-strengthening exercises for the lower extremities supervised in person at a physiotherapy clinic.

Group Type: EXPERIMENTAL

In-person supervised exercise group

Intervention Type: OTHER

The exercise protocol for this group consists of individualized muscle-strengthening exercises for the lower extremities supervised at a physiotherapy clinic. The intervention will occur 2-3 times per week, each lasting approximately 40 minutes. The exercise protocol will consist of six muscle-strengthening exercises for the lower extremities, which will be guided, alternating muscle groups. In the first two weeks of treatment, exercise intensity will be monitored for participants to complete two sets of 8-12 repetitions in dynamic exercises. From the third week onward, participants will progress to one additional set. Adjustments to weight-bearing, the external load imposed by the elastic band, and exercise position throughout the protocol will be performed to maintain the participant's level of effort. After supervised exercise treatment, patients will be encouraged to maintain an exercise routine with the same exercise protocol, however, without physiotherapy supervision.

Interventions

Remote supervised exercise group

The exercise protocol for this group consists of individualized muscle-strengthening exercises for the lower extremities supervised by video call. The intervention will occur 2-3 times per week, each lasting approximately 40 minutes. The exercise protocol will consist of six muscle-strengthening exercises for the lower extremities, which will be guided, alternating muscle groups. In the first two weeks of treatment, exercise intensity will be monitored for participants to complete two sets of 8-12 repetitions in dynamic exercises. From the third week onward, participants will progress to one additional set. Adjustments to weight-bearing, the external load imposed by the elastic band, and exercise position throughout the protocol will be performed to maintain the participant's level of effort. After supervised exercise treatment, patients will be encouraged to maintain an exercise routine with the same exercise protocol, however, without physiotherapy supervision.

Intervention Type: OTHER

In-person supervised exercise group

The exercise protocol for this group consists of individualized muscle-strengthening exercises for the lower extremities supervised at a physiotherapy clinic. The intervention will occur 2-3 times per week, each lasting approximately 40 minutes. The exercise protocol will consist of six muscle-strengthening exercises for the lower extremities, which will be guided, alternating muscle groups. In the first two weeks of treatment, exercise intensity will be monitored for participants to complete two sets of 8-12 repetitions in dynamic exercises. From the third week onward, participants will progress to one additional set. Adjustments to weight-bearing, the external load imposed by the elastic band, and exercise position throughout the protocol will be performed to maintain the participant's level of effort. After supervised exercise treatment, patients will be encouraged to maintain an exercise routine with the same exercise protocol, however, without physiotherapy supervision.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a radiographic diagnosis of unilateral or bilateral knee OA and classified as grades II or III according to the Kellgren and Lawrence criteria (KELLGREN e LAWRENCE, 1957).
• Symptomatic patients according to following American College of Rheumatology criteria - average pain score ≥3 in the last week on the numerical rating scale (0-10), morning stiffness <30 minutes and joint crepitus (ALTMAN et al., 1986).
• Independent walking and internet access.

Exclusion Criteria

• Patients with systemic inflammatory diseases, including rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus.
• Neurological diseases with motor disability.
• Unstable heart diseases.
• History of total knee arthroplasty or lower extremity surgery.
• Body mass index (BMI) ≥ 35 kg/m².
• Physical therapy treatment or participation in a supervised exercise program in the last six months.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: lead

Responsible Party

Cristine Lima Alberton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristine Lima Alberton, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

Federal University of Pelotas, Pelotas, Brazil

Pelotas, Rio Grande do Sul, Brazil

Countries

Brazil

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Other Identifiers

74411723.0.0000.5313

Identifier Type: -

Identifier Source: org_study_id