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Knee OsteoarthritisNCT07705971

Adherence to Home-Based Physiotherapy and Music-Assisted Relaxation After Total Knee Arthroplasty

A study testing Home-Based Physiotherapy and Music-Assisted Progressive Muscle Relaxation in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled study evaluated adherence to two home-based programs after total knee arthroplasty. All participants received a structured home-based physiotherapy program for 6 weeks. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Knee Osteoarthritis, Total Knee Arthroplasty
What is being tested?
Home-Based Physiotherapy and Music-Assisted Progressive Muscle Relaxation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Feb 2024to 17 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 50 to 75 years
  • Scheduled to undergo primary total knee arthroplasty for knee osteoarthritis
  • Voluntary participation in the study
  • Able to understand, speak, and write Turkish
  • Able to understand and follow the verbal and written study instructions
  • Provided written informed consent

Who cannot join

  • Revision total knee arthroplasty
  • Previous major surgery involving the operated lower limb
  • Rheumatoid arthritis, cancer, or another comorbid condition that could substantially affect postoperative recovery or participation
  • Neurological disease causing functional impairment
  • Current use of sedative or hypnotic medication
  • Dementia or another cognitive condition preventing understanding of the study procedures
  • Uncorrected hearing impairment
  • Uncorrected visual impairment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Denizli Private Denipol Hospital, Denizli, Türkiye

    Denizli

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Adherence to Home-Based Physiotherapy and Home-Based Progressive Relaxation Exercises and Examination of Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty

This randomized controlled study evaluated adherence to two home-based programs after total knee arthroplasty. All participants received a structured home-based physiotherapy program for 6 weeks. Participants assigned to the intervention group additionally performed an audio-guided, music-assisted progressive muscle relaxation program. Adherence to the home-based programs was assessed using participant-completed activity diaries. The study also explored changes in pain at rest, during walking, and at night; osteoarthritis-related pain, stiffness, and physical function; sleep quality; depression, anxiety, and stress symptoms; operated-side knee range of motion; lower-extremity physical performance; functional mobility; and health-related quality of life from preoperative baseline to postoperative week 6.

Read the detailed description

Patients undergoing primary total knee arthroplasty for knee osteoarthritis were enrolled and randomly assigned in a 1:1 ratio to an intervention group or a control group using a computer-generated random allocation sequence.

All participants received standard postoperative physiotherapy during hospitalization. At discharge, both groups received a structured home-based physiotherapy program and individual instruction on correct exercise performance. The physiotherapy program was prescribed for 6 weeks, 5 days per week, twice daily. Participants recorded completed sessions in an activity diary.

In addition to home-based physiotherapy, participants in the intervention group received an audio-guided, music-assisted progressive muscle relaxation program. The approximately 27-minute audio recording included verbal instructions for diaphragmatic breathing and the sequential contraction and relaxation of major muscle groups, accompanied by instrumental background music. Participants were instructed to complete one relaxation session before bedtime, 5 days per week, for 6 weeks, and to record each completed session in an activity diary.

At the end of the first postoperative week, participants were contacted individually to review program performance, correct potential errors, answer questions, and address difficulties related to home practice.

The primary feasibility outcome was adherence to the prescribed home-based programs. Physiotherapy adherence was calculated as the percentage of completed sessions out of 60 prescribed sessions. Progressive muscle relaxation adherence was calculated as the percentage of completed sessions out of 30 prescribed sessions. Participants completing at least 80% of the prescribed sessions were classified as adherent. Participants who did not meet the adherence criterion for progressive muscle relaxation were asked structured questions about the reasons for non-adherence.

Exploratory clinical assessments were performed preoperatively and at postoperative week 6. These assessments included pain intensity at rest, during walking, and at night; osteoarthritis-related pain, stiffness, and physical function; sleep quality; depression, anxiety, and stress symptoms; operated-side knee flexion and extension range of motion; lower-extremity functional performance; functional mobility; and health-related quality of life. Because the study primarily focused on adherence and feasibility, analyses of clinical outcomes were considered exploratory rather than confirmatory.

Being tested
Home-Based Physiotherapy, Music-Assisted Progressive Muscle Relaxation
Keywords
Home-Based Physiotherapy, Progressive Muscle Relaxation, Music-Assisted Relaxation, Adherence, Postoperative Rehabilitation, Total Knee Arthroplasty
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-Based PhysiotherapyBehavioural

    Participants received a structured home-based physiotherapy program after discharge following primary total knee arthroplasty. The program was prescribed for 6 weeks, 5 days per week, twice daily. Participants received individual instruction on correct exercise performance and a printed home exercise booklet. Completed sessions were recorded in an activity diary. At the end of the first postoperative week, an individual online contact was conducted to review exercise performance, correct possible errors, and answer questions related to home practice.

  • Music-Assisted Progressive Muscle RelaxationBehavioural

    Participants in the experimental arm received an approximately 27-minute audio-guided, music-assisted progressive muscle relaxation program in addition to home-based physiotherapy. The program was performed once before bedtime, 5 days per week, for 6 weeks. Participants received individual instruction in diaphragmatic breathing, sequential contraction and relaxation of major muscle groups, safe home practice, and use of the audio recording. The recording included verbal guidance delivered by a female voice with instrumental background music and was provided in MP3 format for use on participants' smartphones. Completed sessions were recorded in an activity diary, and an individual online contact was conducted at the end of the first postoperative week.

Study groups in NCT07705971
Study groupRoleWhat they receive
Home-Based Physiotherapy Plus Music-Assisted Progressive Muscle RelaxationExperimentalParticipants received a structured home-based physiotherapy program for 6 weeks, 5 days per week, twice daily. They additionally received an approximately 27-minute audio-guided, music-assisted progressive muscle relaxation program, performed once before bedtime, 5 days per week, for 6 weeks. Participants recorded completed physiotherapy and relaxation sessions in activity diaries. An individual online contact was conducted at the end of the first postoperative week to review performance, reinforce adherence, answer questions, and address difficulties related to home practice.
Receives: Behavioral: Home-Based Physiotherapy; Behavioral: Music-Assisted Progressive Muscle Relaxation
Home-Based PhysiotherapyActive comparatorParticipants received a structured home-based physiotherapy program after discharge. The program was prescribed for 6 weeks, 5 days per week, twice daily. Participants received individual instruction and a home exercise booklet and recorded completed sessions in an activity diary. An individual online contact was conducted at the end of the first postoperative week to check exercise performance, correct potential errors, and answer questions related to home practice.
Receives: Behavioral: Home-Based Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to Home-Based Physiotherapy

    Participants recorded each completed home-based physiotherapy session in weekly activity diaries. Adherence was calculated as the percentage of completed sessions out of 60 prescribed sessions over 6 weeks. Participants who completed at least 48 of 60 sessions, corresponding to at least 80% of the prescribed program, were classified as adherent. The number and percentage of adherent participants were determined for each study arm.

    Measured: From discharge through postoperative week 6

  2. Adherence to the Music-Assisted Progressive Muscle Relaxation Program

    Participants assigned to the experimental arm recorded each completed progressive muscle relaxation session in weekly activity diaries. Adherence was calculated as the percentage of completed sessions out of 30 prescribed sessions over 6 weeks. Participants who completed at least 24 of 30 sessions, corresponding to at least 80% of the prescribed program, were classified as adherent. The number and percentage of adherent participants were determined.

    Measured: From discharge through postoperative week 6

Secondary outcomes (10)
  1. Pain Intensity at Rest Assessed With the Visual Analog Scale

    Pain intensity at rest was assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.

    Measured: Preoperative baseline and postoperative week 6

  2. Pain Intensity During Walking Assessed With the Visual Analog Scale

    Pain intensity during walking was assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.

    Measured: Preoperative baseline and postoperative week 6

  3. Night Pain Intensity Assessed With the Visual Analog Scale

    Pain intensity at night was assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.

    Measured: Preoperative baseline and postoperative week 6

  4. Western Ontario and McMaster Universities Osteoarthritis Index

    Knee osteoarthritis-related pain, stiffness, and physical function were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The index consists of 24 items: 5 pain items, 2 stiffness items, and 17 physical function items. Each item is scored from 0 to 4. The pain score ranges from 0 to 20, the stiffness score from 0 to 8, the physical function score from 0 to 68, and the total score from 0 to 96. Higher scores indicate greater pain and stiffness, greater functional limitation, and poorer overall functional status.

    Measured: Preoperative baseline and postoperative week 6

  5. Pittsburgh Sleep Quality Index

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The seven component scores were summed to obtain a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.

    Measured: Preoperative baseline and postoperative week 6

  6. Depression Anxiety Stress Scale-21

    Depression, anxiety, and stress symptoms were assessed using the 21-item Depression Anxiety Stress Scale (DASS-21). The scale includes three 7-item subscales: depression, anxiety, and stress. Each item is scored from 0 to 3. Each subscale sum was multiplied by 2, yielding a final score ranging from 0 to 42. Higher scores indicate greater symptom severity.

    Measured: Preoperative baseline and postoperative week 6

  7. Knee Range of Motion

    Active knee flexion and extension range of motion of the operated limb were measured separately in degrees using a universal goniometer. Greater knee flexion and a smaller extension deficit, represented by values closer to 0 degrees, indicate better operated-side knee range of motion.

    Measured: Preoperative baseline and postoperative week 6

  8. 30-Second Chair Stand Test

    Lower-extremity functional performance was assessed using the 30-Second Chair Stand Test. Participants were instructed to rise fully from and return to sitting on a standard chair as many times as possible within 30 seconds. The number of correctly completed repetitions was recorded. A higher number of repetitions indicates better lower-extremity functional performance.

    Measured: Preoperative baseline and postoperative week 6

  9. Timed Up and Go Test

    Functional mobility was assessed using the Timed Up and Go Test. Participants were instructed to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down. The time required to complete the test was recorded in seconds. A shorter completion time indicates better functional mobility.

    Measured: Preoperative baseline and postoperative week 6

  10. Nottingham Health Profile

    Health-related quality of life was assessed using Part I of the Nottingham Health Profile (NHP). Part I consists of 38 items across six domains: energy level, pain, emotional reactions, sleep, social isolation, and physical mobility. Each domain score ranges from 0 to 100, and the Part I total score ranges from 0 to 600. Domain scores and the Part I total score were calculated. Higher scores indicate poorer perceived health status.

    Measured: Preoperative baseline and postoperative week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start2 Feb 2024
  3. Primary completion17 Nov 2025
  4. Study completion17 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned in a 1:1 ratio to two parallel groups. Both groups received a 6-week home-based physiotherapy program. The intervention group additionally received a 6-week audio-guided, music-assisted progressive muscle relaxation program. Participants remained in their assigned group throughout the study, with no crossover between interventions.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705971
Sponsor's protocol ID
E-60116787-020-487868
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Home-Based Physiotherapy and Music-Assisted Progressive Muscle Relaxation in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to Home-Based Physiotherapy (time frame: From discharge through postoperative week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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