Clinical trial NCT06101797: Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis
Official title: Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis (RISE-KOA): a Single Blinded, Randomized, Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 48
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12).
measure: Physical function
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12).
Secondary outcomes:
measure: Pain intensity
timeFrame: Follow up period (week 18).
measure: Physical function
timeFrame: Follow up period (week 18).
measure: Pain score
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
measure: Other Symptoms
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
measure: Sport and Recreation Function
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
measure: Knee-related Quality of Life
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
measure: Pain catastrophizing
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
measure: Symptoms of depression, anxiety, and stress
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
measure: Sleep quality
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
measure: Sit-to-stand activity
timeFrame: Baseline (week 0), and Post-intervention (week 12).
measure: Ambulatory transition activity
timeFrame: Baseline (week 0), and Post-intervention (week 12).
measure: Short distance walking activity
timeFrame: Baseline (week 0), and Post-intervention (week 12).
measure: Stair negotiation activity
timeFrame: Baseline (week 0), and Post-intervention (week 12).
measure: Quadriceps femoris muscle thickness
timeFrame: Baseline (week 0), and Post-intervention (week 12).
measure: Quadriceps femoris muscle quality
timeFrame: Baseline (week 0), and Post-intervention (week 12).
measure: Pennation angle
timeFrame: Baseline (week 0), and Post-intervention (week 12).
measure: Fascicle length
timeFrame: Baseline (week 0), and Post-intervention (week 12).
Other outcomes:
measure: Number of medications
timeFrame: Baseline (week 0), During intervention (week 6), Post-intervention (week 12), Follow up period (week 18).
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas, Pelotas, Brazil
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Pelotas
name: Cristine Lima Alberton, PhD
role: PRINCIPAL_INVESTIGATOR
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