search
Back to results

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
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 13, 2019
    Last Updated
    February 19, 2019
    Sponsor
    University Medical Center Groningen
    Collaborators
    Medical Centre Leeuwarden, Martini Hospital Groningen
    search

    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

    Learn more about this trial

    Development of an Effective Home-based-exercise-strategy

    We'll reach out to this number within 24 hrs