Adherence to Home-Based Physiotherapy and Music-Assisted Relaxation After Total Knee Arthroplasty
10 luglio 2026 aggiornato da: UMMUHAN BAS ASLAN, Pamukkale University
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Denizli, Turchia (Türkiye)
- Denizli Private Denipol Hospital, Denizli, Türkiye
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Home-Based Physiotherapy Plus Music-Assisted Progressive Muscle Relaxation
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.
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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.
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.
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Comparatore attivo: Home-Based Physiotherapy
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.
|
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Adherence to Home-Based Physiotherapy
Lasso di tempo: From discharge through postoperative week 6
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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.
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From discharge through postoperative week 6
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Adherence to the Music-Assisted Progressive Muscle Relaxation Program
Lasso di tempo: From discharge through postoperative week 6
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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.
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From discharge through postoperative week 6
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Intensity at Rest Assessed With the Visual Analog Scale
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Pain Intensity During Walking Assessed With the Visual Analog Scale
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Night Pain Intensity Assessed With the Visual Analog Scale
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Western Ontario and McMaster Universities Osteoarthritis Index
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Pittsburgh Sleep Quality Index
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Depression Anxiety Stress Scale-21
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Knee Range of Motion
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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30-Second Chair Stand Test
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Timed Up and Go Test
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Nottingham Health Profile
Lasso di tempo: Preoperative baseline and postoperative week 6
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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.
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Preoperative baseline and postoperative week 6
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Reasons for Non-Adherence to Progressive Muscle Relaxation
Lasso di tempo: Postoperative week 6
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Participants who did not meet the adherence criterion for progressive muscle relaxation were asked structured questions at the final assessment to identify reasons for non-adherence.
Responses were categorized and reported as the number and percentage of participants in each category.
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Postoperative week 6
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 febbraio 2024
Completamento primario (Effettivo)
17 novembre 2025
Completamento dello studio (Effettivo)
17 novembre 2025
Date di iscrizione allo studio
Primo inviato
10 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2026
Primo Inserito (Effettivo)
15 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- E-60116787-020-487868
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .