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Not yet recruitingNCT07333690RCTUpdated Jan 12, 2026

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

An interventional study of Physiotherapist-Supervised Intervention and Home based self managed in Knee Osteoarthritis, sponsored by Muhammed ARCA. Not yet recruiting. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Muhammed ARCA · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Knee Osteoarthritis
  • Physical Activity
  • Exercise Therapy
  • Supervised Exercise
  • Randomized Controlled Trial
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 26 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

This is the only study on the registry with Muhammed ARCA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • 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

  • 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 · Other: Home based self managed

  • Other
    Control Group

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

    Other: Control

Interventions

  • OtherPhysiotherapist-Supervised Intervention

    Conventional Physiotherapy Lifestyle Management Education Individualized Physical Activity Counseling

  • OtherHome based self managed

    Conventional Physiotherapy Lifestyle Management Education Individualized Physical Activity Counseling

  • OtherControl

    Conventional Physiotherapy

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, Week 6, Week 12

  2. 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.

    Time frame: Baseline, Week 6, Week 12

Secondary outcomes

  1. Exercise Adherence Rating Scale

    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.

    Time frame: Baseline, Week 6, Week 12

  2. Serum Irisin Level

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

    Time frame: Baseline, Week 6, Week 12

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — In accordance with the personal data privacy law, information will not be shared with third parties.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07333690
Lead sponsor
Muhammed ARCA
Responsible party
Muhammed ARCA (Director, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital) — Sponsor-investigator
First posted
Jan 12, 2026
Start date
Jan 15, 2026 (estimated)
Primary completion
Jun 15, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
Jan 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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