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

NCT06101797 | Completed

• 1 other identifier: 74411723.0.0000.5313
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Average pain intensity in the last week will be assessed using an 11-point Pain Intensity Numerical Rating Scale (NRS), in which 0 corresponds to "no pain," and 10 represents "worst possible pain." NRS is a patient-reported outcome measure for assessment and clinical decision-making in patients with knee OA with good psychometric properties (ORNETTI et al., 2011).

  Baseline (week 0), During intervention (week 6), Post-intervention (week 12).

• Physical function

  Physical function will be measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) using an Activities of Daily Living subscale. The KOOS is a patient-reported outcome measure composed of 42 items divided into five subscales: Pain, other Symptoms, Activities of daily living, Sport and Recreation Function, and Knee-related Quality of Life. Its score ranges from 0 (extreme problem) to 100 (no problems) separately in each subscale (COLLINS et al., 2011). The Brazilian version of the KOOS questionnaire was recently validated, consisting of an instrument with validity, reliability, and responsiveness in patients with knee OA (ALMEIDA et al., 2022).

  Baseline (week 0), During intervention (week 6), Post-intervention (week 12).

Secondary Outcomes (17)

• Pain intensity

  Follow up period (week 18).

• Physical function

  Follow up period (week 18).

• Pain score

  Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).

• Other Symptoms

  Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).

• Sport and Recreation Function

  Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).

Other Outcomes (1)

• Number of medications

  Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).

Study Arms (2)

Remote supervised exercise group

EXPERIMENTAL

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

Other: Remote supervised exercise group

In-person supervised exercise group

EXPERIMENTAL

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

Other: In-person supervised exercise group

Interventions

Remote supervised exercise group 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.

Remote supervised exercise group

In-person supervised exercise group 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.

In-person supervised exercise group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas, Pelotas, Brazil

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (12)

• Ornetti P, Dougados M, Paternotte S, Logeart I, Gossec L. Validation of a numerical rating scale to assess functional impairment in hip and knee osteoarthritis: comparison with the WOMAC function scale. Ann Rheum Dis. 2011 May;70(5):740-6. doi: 10.1136/ard.2010.135483. Epub 2010 Dec 13.

  PMID: 21149497 BACKGROUND

• Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.

  PMID: 22588746 BACKGROUND

• Almeida GPL, da Costa RMO, Albano TR, Tavares MLA, Marques AP. Translation, cross-cultural adaptation, validation and responsiveness in the Brazilian Portuguese version of the Knee Injury and Osteoarthritis Outcome Score (KOOS-BR). Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3343-3349. doi: 10.1007/s00167-022-06911-w. Epub 2022 Feb 26.

  PMID: 35218377 BACKGROUND

• Sehn F, Chachamovich E, Vidor LP, Dall-Agnol L, de Souza IC, Torres IL, Fregni F, Caumo W. Cross-cultural adaptation and validation of the Brazilian Portuguese version of the pain catastrophizing scale. Pain Med. 2012 Nov;13(11):1425-35. doi: 10.1111/j.1526-4637.2012.01492.x. Epub 2012 Oct 4.

  PMID: 23036076 BACKGROUND

• Vignola RC, Tucci AM. Adaptation and validation of the depression, anxiety and stress scale (DASS) to Brazilian Portuguese. J Affect Disord. 2014 Feb;155:104-9. doi: 10.1016/j.jad.2013.10.031. Epub 2013 Oct 28.

  PMID: 24238871 BACKGROUND

• Bertolazi AN, Fagondes SC, Hoff LS, Dartora EG, Miozzo IC, de Barba ME, Barreto SS. Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index. Sleep Med. 2011 Jan;12(1):70-5. doi: 10.1016/j.sleep.2010.04.020. Epub 2010 Dec 9.

  PMID: 21145786 BACKGROUND

• Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.

  PMID: 23680877 BACKGROUND

• Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.

  PMID: 10380242 BACKGROUND

• Taniguchi M, Fukumoto Y, Kobayashi M, Kawasaki T, Maegawa S, Ibuki S, Ichihashi N. Quantity and Quality of the Lower Extremity Muscles in Women with Knee Osteoarthritis. Ultrasound Med Biol. 2015 Oct;41(10):2567-74. doi: 10.1016/j.ultrasmedbio.2015.05.014. Epub 2015 Jun 20.

  PMID: 26099784 BACKGROUND

• Paris MT, Mourtzakis M. Muscle Composition Analysis of Ultrasound Images: A Narrative Review of Texture Analysis. Ultrasound Med Biol. 2021 Apr;47(4):880-895. doi: 10.1016/j.ultrasmedbio.2020.12.012. Epub 2021 Jan 13.

  PMID: 33451817 BACKGROUND

• Blazevich AJ, Cannavan D, Coleman DR, Horne S. Influence of concentric and eccentric resistance training on architectural adaptation in human quadriceps muscles. J Appl Physiol (1985). 2007 Nov;103(5):1565-75. doi: 10.1152/japplphysiol.00578.2007. Epub 2007 Aug 23.

  PMID: 17717119 BACKGROUND

• Carvalho MTX, Alberton CL. Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis (RISE-KOA): study protocol for a non-inferiority randomized controlled trial. Trials. 2025 May 20;26(1):165. doi: 10.1186/s13063-025-08884-w.

  PMID: 40394687 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Cristine Lima Alberton, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be implemented by the outcome assessor. All measurements (PROMs, muscle architecture, and functional outcomes) will be conducted by an evaluator blinded to the participant's group. Due to the nature of the intervention, investigators conducting the exercise intervention and participants will not be able to be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a non-inferiority randomized clinical trial with two parallel groups in a single center with blinding of outcome assessors. Patients, males, and females with symptomatic and radiographic knee OA will be allocated to supervised in-person or remote exercise groups based on a stratified randomization method, considering the baseline outcome age (in the categories of participants aged 45 to 54 years old or 55 to 80 years old). A single independent researcher assistant will carry out randomization with a 1:1 ratio.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 26, 2023
• Study Start: December 4, 2023
• Primary Completion: January 15, 2025
• Study Completion: March 8, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)