The Effects of Healthy Lifestyle Management Training and Personalized Physical Activity Counseling: A Randomized Controlled Trial

Official title

The Effect of Healthy Lifestyle Management Education and Personalized Physical Activity Counseling on Pain, Functionality, Exercise Adherence, and Irisin Level in Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Overview

Knee osteoarthritis is a common condition that causes knee pain, stiffness, and difficulty in daily activities. Physical activity and exercise are recommended as part of the treatment; however, many individuals have difficulty maintaining regular exercise over time. The purpose of this study is to evaluate the effects of different physical activity intervention approaches on pain, physical function, and exercise adherence in individuals with knee osteoarthritis. Participants will be randomly assigned to one of three groups. One group will receive a physiotherapist-supervised exercise and physical activity program. The second group will follow an individualized home-based physical activity program that they will perform independently after receiving initial instruction. The third group will receive usual care and will serve as the control group. The intervention period will last six weeks. Participants in the intervention groups will then be followed for an additional six weeks using telephone-based follow-up to monitor adherence and ongoing physical activity. Outcomes related to pain, physical function, physical activity, and adherence to exercise will be assessed at different time points during the study. The results of this study are expected to improve understanding of how supervised and home-based physical activity programs may contribute to the management of knee osteoarthritis and support the development of effective rehabilitation strategies.

Detailed description

Knee osteoarthritis is a common musculoskeletal condition characterized by pain, reduced physical function, and limitations in daily activities. Regular physical activity and exercise are strongly recommended for the management of knee osteoarthritis; however, long-term adherence to exercise programs remains a major challenge for many patients.

The aim of this randomized controlled trial is to investigate the effects of different modes of physical activity intervention, in addition to usual care, on pain, physical function, exercise adherence, and selected cardiometabolic biomarkers in individuals with knee osteoarthritis.

Eligible participants diagnosed with knee osteoarthritis will be randomly allocated into one of three groups. The first group will receive a physiotherapist-supervised intervention, consisting of structured exercise sessions combined with personalized physical activity counseling delivered by a physiotherapist. The second group will receive an individualized home-based intervention, in which participants will perform the prescribed exercise and physical activity program independently at home following initial instruction and guidance. The third group will serve as the control group and will receive usual care only.

The intervention period will last six weeks for both intervention groups. Following the intervention phase, participants in the intervention groups will be followed for an additional six weeks through telephone-based monitoring to support adherence and record ongoing physical activity. Outcome assessments will be conducted at baseline, at the end of the six-week intervention period, and after completion of the follow-up period.

Primary outcomes will include pain intensity and physical function. Secondary outcomes will include exercise adherence, physical activity level, and selected cardiometabolic biomarkers. The results of this study are expected to provide evidence on the comparative effectiveness of supervised versus home-based physical activity interventions for individuals with knee osteoarthritis and to inform clinical practice and rehabilitation strategies.

Interventions

• Other Physiotherapist-Supervised Intervention
  Conventional Physiotherapy Lifestyle Management Education Individualized Physical Activity Counseling
• Other Home based self managed
  Conventional Physiotherapy Lifestyle Management Education Individualized Physical Activity Counseling
• Other Control
  Conventional Physiotherapy

Primary outcome measures

• Physical Function [Time frame: Baseline, Week 6, Week 12]
• Pain Severity [Time frame: Baseline, Week 6, Week 12]

Secondary outcome measures (2)

• Exercise Adherence Rating Scale [Time frame: Baseline, Week 6, Week 12]
• Serum Irisin Level [Time frame: Baseline, Week 6, Week 12]

Eligibility criteria

Inclusion criteria

• Age ≥ 40 years

Diagnosed with knee osteoarthritis according to clinical and/or radiological criteria

Ability to walk independently

Willingness to participate and provide written informed consen

Exclusion criteria

• History of knee surgery within the last 6 months

Inflammatory rheumatic diseases

Neurological or cardiovascular conditions limiting physical activity

Participation in a structured exercise program within the last 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07333690 · FZT-OA-Intervention-631

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗