NCT03846063

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

February 13, 2019

Last Update Submit

April 16, 2024

Conditions

Osteoarthritis, HipTotal Hip Arthroplasty

Keywords

Total hip arthroplastyPhysiotherapyOsteoarthritisUsual careHome-based rehabilitation program

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 weeks

  • 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.

    4 weeks

  • 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.

    12 weeks

Secondary Outcomes (5)

  • Change in mobility (objective measurement (TUG))

    6 months

  • Change in functional status (objective measurement (FTSST))

    6 months

  • Change in functional status and hip-related quality of life (self-reported measurement (HOOS))

    6 months

  • Change in health-related quality of life (self-reported measurement (SF-36))

    6 months

  • Change in health-related quality of life (self-reported measurement (EQ-5D-3L))

    6 months

Study Arms (1)

Intervention: Home-based rehabilitation program

EXPERIMENTAL

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

Other: Home-based rehabilitation program

Interventions

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.

Intervention: Home-based rehabilitation program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32338621DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Martin Stevens, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 19, 2019

Study Start

December 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share