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

NCT07333690 | Not Yet Recruiting DMC

• 1 other identifier: FZT-OA-Intervention-631
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Physical Activity; Exercise Therapy; Supervised Exercise; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Physical Function

  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

  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 Outcomes (2)

• Exercise Adherence Rating Scale

  Baseline, Week 6, Week 12

• Serum Irisin Level

  Baseline, Week 6, Week 12

Study Arms (3)

Physiotherapist-Supervised Intervention Group

EXPERIMENTAL

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

Home-Based Self-Managed Intervention Group

ACTIVE COMPARATOR

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; Other: Home based self managed

Control Group

OTHER

Participants will receive conventional physiotherapy only, as routinely applied in the hospital setting.

Other: Control

Interventions

Control OTHER

Conventional Physiotherapy

Control Group

Home based self managed OTHER

Conventional Physiotherapy Lifestyle Management Education Individualized Physical Activity Counseling

Home-Based Self-Managed Intervention Group

Physiotherapist-Supervised Intervention OTHER

Conventional Physiotherapy Lifestyle Management Education Individualized Physical Activity Counseling

Home-Based Self-Managed Intervention Group; Physiotherapist-Supervised Intervention Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammed ARCA: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share