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Osteoarthritis, HipNCT03846063

Development of an Effective Home-based-exercise-strategy

A study testing Home-based rehabilitation program in people with Osteoarthritis, Hip and Total Hip Arthroplasty, run by University Medical Center Groningen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Osteoarthritis, Hip, Total Hip Arthroplasty
What is being tested?
Home-based rehabilitation program
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Dec 2015to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: Pilot Study Into the Development of an Effective Home-based-exercise-strategy for Patients After THA Delivered on a Tablet-PC

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.

Being tested
Home-based rehabilitation program
Keywords
Total hip arthroplasty, Physiotherapy, Osteoarthritis, Usual care, Home-based rehabilitation program
Medical subject headings
Osteoarthritis, Hip, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based rehabilitation programOther

    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.

Study groups in NCT03846063
Study groupRoleWhat they receive
Intervention: Home-based rehabilitation programExperimentalA 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
Receives: Other: Home-based rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 4 weeks

  3. 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.

    Measured: 12 weeks

Secondary outcomes (5)

  1. 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).

    Measured: 6 months

  2. 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).

    Measured: 6 months

  3. 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).

    Measured: 6 months

  4. 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).

    Measured: 6 months

  5. 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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2019
  2. Study startDec 2015
  3. Primary completionAug 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03846063
Sponsor's protocol ID
NL50372
Status last verified
Apr 2024
First submitted
13 Feb 2019
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32338621

Questions about this trial

What is this clinical trial studying?

A study testing Home-based rehabilitation program in people with Osteoarthritis, Hip and Total Hip Arthroplasty, run by University Medical Center Groningen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence of a home-based rehabilitation program (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03846063, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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