Adherence to Home-Based Physiotherapy and Music-Assisted Relaxation After Total Knee Arthroplasty
10. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
50
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Denizli, Turecko (Türkiye)
- Denizli Private Denipol Hospital, Denizli, Türkiye
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Adherence to Home-Based Physiotherapy
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Intensity at Rest Assessed With the Visual Analog Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Reasons for Non-Adherence to Progressive Muscle Relaxation
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
2. února 2024
Primární dokončení (Aktuální)
17. listopadu 2025
Dokončení studie (Aktuální)
17. listopadu 2025
Termíny zápisu do studia
První předloženo
10. července 2026
První předloženo, které splnilo kritéria kontroly kvality
10. července 2026
První zveřejněno (Aktuální)
15. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
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