Development of an Effective Home-based-exercise-strategy
Primary Purpose
Osteoarthritis, Hip, Total Hip Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home-based rehabilitation program
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis, Hip focused on measuring Total hip arthroplasty, Physiotherapy, Osteoarthritis, Usual care, Home-based rehabilitation program
Eligibility Criteria
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
Exclusion Criteria:
- Revision surgery
- Medical conditions that disallow independent living
- Cognitive impairment
- Inability to sufficiently read and understand Dutch
- Participating in another rehabilitation program
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention: Home-based rehabilitation program
Arm Description
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
Outcomes
Primary Outcome Measures
Adherence of a home-based rehabilitation program
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
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
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
Change in mobility (objective measurement (TUG))
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))
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 functional status and hip-related quality of life (self-reported measurement (HOOS))
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 (SF-36))
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 health-related quality of life (self-reported measurement (EQ-5D-3L))
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).
Full Information
NCT ID
NCT03846063
First Posted
February 13, 2019
Last Updated
February 19, 2019
Sponsor
University Medical Center Groningen
Collaborators
Medical Centre Leeuwarden, Martini Hospital Groningen
1. Study Identification
Unique Protocol Identification Number
NCT03846063
Brief Title
Development of an Effective Home-based-exercise-strategy
Official Title
Pilot Study Into the Development of an Effective Home-based-exercise-strategy for Patients After THA Delivered on a Tablet-PC
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Medical Centre Leeuwarden, Martini Hospital Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Total Hip Arthroplasty
Keywords
Total hip arthroplasty, Physiotherapy, Osteoarthritis, Usual care, Home-based rehabilitation program
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Home-based rehabilitation program
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Home-based rehabilitation program
Intervention Description
The duration of the program is 12 weeks. Patients start the program within 7 days after of the surgery. Patients perform exercises independently at home using the tablet PC for instructions. The program includes strengthening and walking exercises based on increasing the muscle force, balance, and functionality. The exercises comprise movements that train abductors, flexors, and extensors of the affected hip. The content of the program is based on previous research and on guidelines from the American Association of Orthopaedic Surgeons. For the rest, the program is designed in line with the most recent guidelines from the Royal Dutch Society for Physical Therapy. Patients are asked to exercise at least 5 days a week, with rest days on Thursday and Sunday. Strengthening exercises will be performed 3 times a week. The instructions for the exercises will be provided by videos on the tablet PC, which patients have to imitate.
Primary Outcome Measure Information:
Title
Adherence of a home-based rehabilitation program
Description
Adherence to the rehabilitation program will be evaluated on the basis of the completion of the planned exercises.
Time Frame
12 weeks
Title
Patient experience of a home-based rehabilitation program at week 4
Description
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.
Time Frame
4 weeks
Title
Patient experience of a home-based rehabilitation program at week 12
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in mobility (objective measurement (TUG))
Description
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).
Time Frame
6 months
Title
Change in functional status (objective measurement (FTSST))
Description
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).
Time Frame
6 months
Title
Change in functional status and hip-related quality of life (self-reported measurement (HOOS))
Description
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).
Time Frame
6 months
Title
Change in health-related quality of life (self-reported measurement (SF-36))
Description
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).
Time Frame
6 months
Title
Change in health-related quality of life (self-reported measurement (EQ-5D-3L))
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Revision surgery
Medical conditions that disallow independent living
Cognitive impairment
Inability to sufficiently read and understand Dutch
Participating in another rehabilitation program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Stevens, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32338621
Citation
Wijnen A, Hoogland J, Munsterman T, Gerritsma CL, Dijkstra B, Zijlstra WP, Dekker JS, Annegarn J, Ibarra F, Slager GE, Zijlstra W, Stevens M. Effectiveness of a Home-Based Rehabilitation Program After Total Hip Arthroplasty Driven by a Tablet App and Remote Coaching: Nonrandomized Controlled Trial Combining a Single-Arm Intervention Cohort With Historical Controls. JMIR Rehabil Assist Technol. 2020 Apr 27;7(1):e14139. doi: 10.2196/14139.
Results Reference
derived
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Development of an Effective Home-based-exercise-strategy
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