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CompletedNCT06009341Updated Dec 15, 2025

Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients

An interventional study of Rehabilitation in Knee Arthroplasty, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Muğla Sıtkı Koçman University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2023, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

In this study, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. In this randomized controlled study, the trainings will be offered face-to-face after the initial evaluation and within the scope of telemedicine with prepared videos. The first evaluation will be performed on the first postoperative day and the last evaluation will be performed 3 months postoperatively. The aim of this study is to evaluate the effectiveness of a comprehensive education program consisting of pain management, relaxation, respiration, massage and fall components in patients with total knee arthroplasty.

02

Conditions studied

  • Knee Arthroplasty
03

In context

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.

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

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants aged 50 and over
  • Participants indicated for unilateral or bilateral total knee arthoplasty
  • Individuals to be followed after surgery

Exclusion criteria

Exclusion Criteria:

  • Other surgeries
  • Individuals with neurological and orthopedic diagnoses
  • Individuals with cognitive, hearing, speech and psychiatric problems that prevent them from communicating
  • Illiterate individuals
  • Presence of malignancy
  • Not signing the consent form
05

Study design

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

Study arms

  • Experimental
    Intervention Group

    In this study, the intervention group will be given comprehensive training in addition to standard conservative follow-up (pain spasm pain cycle, pain does not always mean that there is a problem, tissue repair, fall prevention, lower extremity classical massage, muscle relaxation relaxation methods, respiratory control), while the control group will be followed only with conservative treatment applications (muscle strengthening, stretching). The applications will be performed with 10 repetitions each day.

    Other: Rehabilitation

  • Active comparator
    Control Group

    The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given.

    Other: Rehabilitation

Interventions

  • OtherRehabilitation

    The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. In addition, the intervention group will be taught the training program and applications.

06

What researchers measure

Primary outcomes

  1. Knee Society Short Form (KSSF)

    The scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.

    Time frame: Change from Baseline KSSF at 12 weeks

  2. Visual Analog Scale (VAS)

    On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).

    Time frame: Change from Baseline VAS at 12 weeks

  3. Tampa Scale for Kinesiophobia (TSK)

    The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.

    Time frame: Change from Baseline TSK at 12 weeks

  4. EQ-5D-3L Quality of Life Scale

    The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".

    Time frame: Change from Baseline EQ-5D-3L at 12 weeks

  5. Pain Catastrophising Scale (PCS)

    Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.

    Time frame: Change from Baseline PCS at 12 weeks

  6. Activity Specific Balance Confidence Scale (ABC)

    This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.

    Time frame: Change from Baseline ABC at 12 weeks

  7. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    The Fear of Falling Avoidance Behavior Questionnaire (FFABQ) was developed to assess avoidance behavior (activity limitation and participation restriction) in community-dwelling older adults. The FFABQ consists of 14 items ranked using a five-point Likert style, resulting in a maximum possible score of 56 points. A high score indicates activity limitation and participation restriction.

    Time frame: Change from Baseline FFABQ at 12 weeks

07

Study locations

1 site
  • Muğla
    Muğla, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

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 Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06009341
Lead sponsor
Muğla Sıtkı Koçman University
Responsible party
Fatih Ozden (Assistant Professor, Muğla Sıtkı Koçman University) — Principal investigator
First posted
Aug 24, 2023
Start date
May 19, 2023
Primary completion
Nov 30, 2025
Completion
Dec 1, 2025
Last update
Dec 15, 2025

Study contacts

Fatih Özden, PhD
study director · Muğla Sıtkı Koçman University

Oversight

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

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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