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

NCT07705971 | Completed

• 1 other identifier: E-60116787-020-487868
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty

Keywords

Home-Based Physiotherapy; Progressive Muscle Relaxation; Music-Assisted Relaxation; Adherence; Postoperative Rehabilitation; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• 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.

  From discharge through postoperative week 6

• 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.

  From discharge through postoperative week 6

Secondary Outcomes (10)

• Pain Intensity at Rest Assessed With the Visual Analog Scale

  Preoperative baseline and postoperative week 6

• Pain Intensity During Walking Assessed With the Visual Analog Scale

  Preoperative baseline and postoperative week 6

• Night Pain Intensity Assessed With the Visual Analog Scale

  Preoperative baseline and postoperative week 6

• Western Ontario and McMaster Universities Osteoarthritis Index

  Preoperative baseline and postoperative week 6

• Pittsburgh Sleep Quality Index

  Preoperative baseline and postoperative week 6

Other Outcomes (1)

• Reasons for Non-Adherence to Progressive Muscle Relaxation

  Postoperative week 6

Study Arms (2)

Home-Based Physiotherapy Plus Music-Assisted Progressive Muscle Relaxation

EXPERIMENTAL

Participants 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.

Behavioral: Home-Based Physiotherapy; Behavioral: Music-Assisted Progressive Muscle Relaxation

Home-Based Physiotherapy

ACTIVE COMPARATOR

Participants 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.

Behavioral: Home-Based Physiotherapy

Interventions

Home-Based Physiotherapy BEHAVIORAL

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.

Home-Based Physiotherapy; Home-Based Physiotherapy Plus Music-Assisted Progressive Muscle Relaxation

Music-Assisted Progressive Muscle Relaxation BEHAVIORAL

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.

Home-Based Physiotherapy Plus Music-Assisted Progressive Muscle Relaxation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Denizli Private Denipol Hospital, Denizli, Türkiye

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to group allocation. Due to the nature of the interventions, participants and the physiotherapist delivering the interventions could not be blinded. Participants were instructed not to disclose their group allocation to the outcomes assessor during the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Physiotherapy and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: February 2, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)