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NCT Number: NCT07333690

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapist-Supervised Intervention

Other

Conventional Physiotherapy

Lifestyle Management Education

Individualized Physical Activity Counseling

Home based self managed

Other

Conventional Physiotherapy Lifestyle Management Education Individualized Physical Activity Counseling

Control

Other

Conventional Physiotherapy

Primary outcomes

  1. Physical Function

    Time frame: Baseline, Week 6, Week 12

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function subscale will be used to assess the physical functional status of the patients. This subscale consists of 17 items. Each item is scored on a Likert scale from 0 to 4 (0 = None, 4 = Extreme). The total score for this subscale ranges from 0 to 68 points, where higher scores indicate worse physical function (greater functional limitation).

  2. Pain Severity

    Time frame: Baseline, Week 6, Week 12

    Numeric Analog Scale (NAS) Pain intensity will be assessed using the Numerical Rating Scale (NRS). The scale consists of a single item where patients rate their pain on a 11-point scale ranging from 0 to 10. A score of 0 represents "no pain" and a score of 10 represents "the worst possible pain." Higher scores indicate greater pain intensity.

Secondary outcomes

  1. Exercise Adherence Rating Scale

    Time frame: Baseline, Week 6, Week 12

    The Exercise Adherence Rating Scale (EARS) will be used to measure the patients' adherence to the prescribed exercise program. The scale (Section B) consists of 6 items. Each item is scored on a 5-point Likert scale (0 = Completely Agree, 4 = Completely Disagree). The total score ranges from 0 to 24, where higher scores indicate better adherence to the exercise program.

  2. Serum Irisin Level

    Time frame: Baseline, Week 6, Week 12

    Serum irisin concentrations will be measured using an Enzyme-Linked Immunosorbent Assay (ELISA) kit.

Sponsors and collaborators

Lead sponsor

Muhammed ARCA

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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