Development of an Effective Home-based-exercise-strategy

Not Applicable

Completed

• Conditions: Total Hip Arthroplasty; Osteoarthritis, Hip
• Interventions: Other: Home-based rehabilitation program

• Registration Number: NCT03846063
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Osteoarthritis is one of the most common chronic diseases of the musculoskeletal system in elderly. Patients with osteoarthritis experience pain, stiffness and loss of mobility. Due to ageing Western societies in the coming decades the number of elderly with osteoarthritis will progressively increase. Osteoarthritis is a common indicator for a Total Hip Arthroplasty (THA). A hip replacement is one of the most successful orthopedic surgeries. However, with regard to the postoperative rehabilitation a lot can be improved. The current situation after a THA is that physical therapy in the Netherlands is not prescribed by default. Patients are resigned from the hospital and receive home exercises. However, it is not clear whether patients actually carry out these exercises and whether they perform the exercises correctly.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2017-08
• Study Completion: 2017-12
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Aged between 18 and 75 years
• Living independent
• Waiting for THA at either the Martini Hospital Groningen or the Medical Centre Leeuwarden in the Netherlands

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Exclusion Criteria

• Revision surgery
• Medical conditions that disallow independent living
• Cognitive impairment
• Inability to sufficiently read and understand Dutch
• Participating in another rehabilitation program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention: Home-based rehabilitation program	Home-based rehabilitation program	A twelve-week home-based exercise strategy will be offered to patients after their discharge from the hospital. This home-based exercise strategy will be delivered by means of videos on a tablet-pc and consist of specified exercise instructions for improving muscle strength, balance and functional movements. The intervention group will be compared with existing patientdata who received usual care in the Netherlands

Primary Outcome Measures

Name	Time	Method
Adherence of a home-based rehabilitation program	12 weeks	Adherence to the rehabilitation program will be evaluated on the basis of the completion of the planned exercises.
Patient experience of a home-based rehabilitation program at week 4	4 weeks	Patient experience will be done in week 4 (T1) with a questionnaire adapted from the sensing and action to support mobility in ambient assisted living subject evaluation form \[12,13\]. The questionnaire contains questions about the user experience, the perceived intensity of the intervention, coaching, wearing of the sensor, and acceptability of the technology.
Patient experience of a home-based rehabilitation program at week 12	12 weeks	Patient experience will be done at week 12 at the end of the program (T2) with a questionnaire adapted from the sensing and action to support mobility in ambient assisted living subject evaluation form \[12,13\]. The questionnaire contains questions about the user experience, the perceived intensity of the intervention, coaching, wearing of the sensor, and acceptability of the technology.

Secondary Outcome Measures

Name	Time	Method
Change in mobility (objective measurement (TUG))	6 months	To assess mobility objectively, the Timed Up \& Go test (TUG) will be performed. The TUG is an accepted test to measure mobility. During the TUG, participants will be instructed to stand up from the chair, walk three meters, turn around, walk back and sit down on the chair again. Participants will be asked to walk at a fast but safe pace. The test will be performed three times. The TUG is considered reliable and practical. Measurements will be taken preoperatively (T0) and postoperatively at 4 weeks (T1), 12 weeks (T2) and 6 months (T3).
Change in functional status (objective measurement (FTSST))	6 months	To assess functional status objectively, the Five Times Sit-to Stand Test (FTSST) will be performed. The FTSST is a clinical test to assess lower extremity power and balance. For the FTSST, participants will be asked to stand up and sit down five times at a fast speed. Subjects will be instructed to perform the test with arms crossed in front of the abdomen when possible. The test was performed twice. The FTSST shows good reliability and validity. Measurements will be taken preoperatively (T0) and postoperatively at 4 weeks (T1), 12 weeks (T2) and 6 months (T3).
Change in health-related quality of life (self-reported measurement (SF-36))	6 months	To measure health-related quality of life, the Short Form 36 (SF-36) will used. The SF-36 is a widely used generic health status questionnaire consisting of 36 questions, divided into eight health concepts: physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. Each raw scale score will be transformed into a linear 0-100 scale. The higher the score, the less disability. In this study only the subscales physical functioning, role limitations due to physical problems, and general health perceptions were analyzed. The SF-36 has proven to be practical, reliable and valid within a general and chronic disease population. Measurements will be taken preoperatively (T0) and postoperatively at 4 weeks (T1), 12 weeks (T2) and 6 months (T3).
Change in functional status and hip-related quality of life (self-reported measurement (HOOS))	6 months	The self-reported Hip disability and Osteoarthritis Outcome Score (HOOS) will be used as a disease-specific outcome measure of functional status and quality of life. The HOOS consists of five subscales: pain, other symptoms, function in activities of daily living, function in sport and recreational activities, and hip-related quality of life. Standardized response options are given and each question is scored from 0-4 (on a 5-point Likert scale). A normalized score, ranging from 0-100, will be subsequently calculated for each subscale (0 indicating extreme symptoms and 100 no symptoms). The Dutch version has been proven valid and reliable. Measurements will be taken preoperatively (T0) and postoperatively at 4 weeks (T1), 12 weeks (T2) and 6 months (T3).
Change in health-related quality of life (self-reported measurement (EQ-5D-3L))	6 months	To measure health-related quality of life, the EuroQol 5 Dimensions 3 Level Questionnaire (EQ-5D-3L) will used. The EQ-5D-3L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three degrees of severity: no problem, some problems and major problems. Actual quality of life will also be identified on the EQ-5D-3L Visual Analogue Scale. Measurements will be taken preoperatively (T0) and postoperatively at 4 weeks (T1), 12 weeks (T2) and 6 months (T3).