Comparison of Adherence to Home-Based Physiotherapy and Home-Based Progressive Relaxation Exercises and Examination of Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pamukkale University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Adherence to Home-Based Physiotherapy
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Adherence to Home-Based Physiotherapy
Time Frame: From discharge through postoperative week 6
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.
Adherence to the Music-Assisted Progressive Muscle Relaxation Program
Time Frame: From discharge through postoperative week 6
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.
Secondary Outcomes
- 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)
- 30-Second Chair Stand Test(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)
- Depression Anxiety Stress Scale-21(Preoperative baseline and postoperative week 6)
- Knee Range of Motion(Preoperative baseline and postoperative week 6)
- Timed Up and Go Test(Preoperative baseline and postoperative week 6)
- Nottingham Health Profile(Preoperative baseline and postoperative week 6)
Investigators
UMMUHAN BAS ASLAN
Professor, Faculty of Physiotherapy and Rehabilitation
Pamukkale University