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

January 2, 2026 updated by: Muhammed ARCA

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapist-Supervised Intervention Group
Participants will receive conventional physiotherapy combined with physiotherapist-supervised lifestyle management education and individualized physical activity counseling for 6 weeks, followed by a 6-week telephone-based follow-up.
Other: Physiotherapist-Supervised Intervention

Conventional Physiotherapy

Lifestyle Management Education

Individualized Physical Activity Counseling
Active Comparator: Home-Based Self-Managed Intervention Group
Participants will receive lifestyle management education and an individualized home-based physical activity program, which they will perform independently without direct physiotherapist supervision.
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 Group
Participants will receive conventional physiotherapy only, as routinely applied in the hospital setting.
Other: Control
Conventional Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Week 6, Week 12
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.
Baseline, Week 6, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 6, Week 12
Serum Irisin Level
Time Frame: Baseline, Week 6, Week 12
Serum irisin concentrations will be measured using an Enzyme-Linked Immunosorbent Assay (ELISA) kit.
Baseline, Week 6, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammed ARCA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZT-OA-Intervention-631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In accordance with the personal data privacy law, information will not be shared with third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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