Effects of Early Home-based Strength and Sensory-motor Training After THA on Functional Outcome and Patient Satisfaction
April 29, 2022 updated by: Valdoltra Orthopedic Hospital
Effects of Early Home-based Strength and Sensory-motor Training After Total Hip Arthroplasty: a Randomised Controlled Trial
A prospective multicentre randomised clinical trial of 250 selected patients with THA, who will be randomly assigned to intervention (IG) or control group (CG).
Both will have standard physiotherapy during hospitalisation, IG will additionally learn strength and sensory-motor training exercises.
Follow up will be performed with physical tests, maximal voluntary isometric contractions and outcome assessment questionnaires at baseline and 1, 3 and 12 months after surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective multicentre randomised clinical trial to be conducted in orthopaedic departments of two Slovenian hospitals.
In each hospital 125 patients aged 60 or older with unilateral osteoarthritis, ASA score 1-3, signed informed consent, access to watching USB videos and without terminal illnesses disabling rehabilitation participation, will be randomly assigned to intervention (IG) or control group (CG).
Total hip arthroplasty with anterior approach will be performed.
All patients will get current standard physiotherapy during hospitalisation.
Patients in IG will additionally learn strength and sensory-motor training exercises.
Patients in both groups will get USB drives with exercise videos, written exercise instructions and training diary.
Physiotherapists will perform measurements (physical tests and maximal voluntary isometric contractions) and patients will fill in outcome assessment questionnaires (Harris Hip Score and 36-Item Short Form Health Survey) at baseline and 1, 3 and 12 months after surgery.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankaran, Slovenia, 6280
- Valdoltra Orthopaedic Hospital
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Novo Mesto, Slovenia, 8000
- General hospital Novo mesto
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing elective primary unilateral THA for OA.
- Patients older than 60 years at the time of surgery.
- Ability to watch exercise videos on USB drive.
- American Society of Anaesthesiologists (ASA) Classification 1-3.
- Patients are able to consent and willing to comply with the study protocol.
Exclusion Criteria:
- Primary THA for a diagnosis other than OA (aseptic femoral head necrosis, dysplastic hip…) or revision THA.
- Patients having previous hip interventions (osteosynthesis, osteotomy…)
- Discharge to rehabilitation units or nursing homes.
- Patients unable to consent and comply with the study protocol (diagnosed with dementia, mental disorders, poor preoperative physical status - neurological disorders, amputations, trouble walking with walkers or wheelchairs, painful hip or knee prosthesis in other joints).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group OBV
Intervention Group in Valdoltra Orthopaedic Hospital.
Patients will get current standard physiotherapy during hospitalisation and extra one-on-one training to learn strength and sensory-motor exercises.
At discharge they will get USB drives with exercise videos, written exercise instructions, training diary and exercise aids for strength and sensory-motor training.
|
Early postoperative strength and sensory-motor training after total hip arthroplasty.
Training consists of: hip muscles strengthening (focusing on abductors); hip and pelvic stabilization exercises; ankle and knee muscles strengthening (better dissipation of impact forces and femoral inner rotation control); trunk muscles strengthening (stabilization of pelvis and lumbar spine and reduction of local loading).
Mobilisation using a walking aid (usually two crutches, rarely a walker), deep vein thrombosis (DVT) prevention exercises, lower limb range of motion exercises and isometric strengthening program
|
|
Active Comparator: Control Group OBV
Control Group in Valdoltra Orthopaedic Hospital.
Patients will get current standard physiotherapy during hospitalisation and USB drives with exercise videos, written exercise instructions and training diary at discharge.
|
Mobilisation using a walking aid (usually two crutches, rarely a walker), deep vein thrombosis (DVT) prevention exercises, lower limb range of motion exercises and isometric strengthening program
|
|
Experimental: Intervention Group SBNM
Intervention Group in General Hospital Novo mesto.
Patients will get current standard physiotherapy during hospitalisation and extra one-on-one training to learn strength and sensory-motor exercises.
At discharge they will get USB drives with exercise videos, written exercise instructions, training diary and exercise aids for strength and sensory-motor training.
|
Early postoperative strength and sensory-motor training after total hip arthroplasty.
Training consists of: hip muscles strengthening (focusing on abductors); hip and pelvic stabilization exercises; ankle and knee muscles strengthening (better dissipation of impact forces and femoral inner rotation control); trunk muscles strengthening (stabilization of pelvis and lumbar spine and reduction of local loading).
Mobilisation using a walking aid (usually two crutches, rarely a walker), deep vein thrombosis (DVT) prevention exercises, lower limb range of motion exercises and isometric strengthening program
|
|
Active Comparator: Control Group SBNM
Control Group in General Hospital Novo mesto.
Patients will get current standard physiotherapy during hospitalisation and USB drives with exercise videos, written exercise instructions and training diary at discharge.
|
Mobilisation using a walking aid (usually two crutches, rarely a walker), deep vein thrombosis (DVT) prevention exercises, lower limb range of motion exercises and isometric strengthening program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in isometric hip and trunk muscles strength
Time Frame: Baseline (before surgery), 1, 3 and 12 months after surgery
|
Maximal voluntary isometric contractions.
We will use specially prepared measuring device with dynamometer attached to stiff bands metal chains.
For the assessment of maximal isometric strength, a maximal voluntary isometric contraction for 6 seconds is asked.
The same procedure to obtain a maximal voluntary contraction is used for every strength measure.
3 movement planes are assessed for trunk (extension, left and right abduction) and operated hip (flexion, extension and abduction) and 2 for opposite hip (extension, abduction).
|
Baseline (before surgery), 1, 3 and 12 months after surgery
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Change in 8UG
Time Frame: Baseline (before surgery), 1, 3 and 12 months after surgery
|
8-Feet Up and Go Test.
The 8UG is a timed test that requires one to stand up from a chair with armrests, walk to a cone 8 feet away, turn around, return to the chair and sit down.
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Baseline (before surgery), 1, 3 and 12 months after surgery
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|
Change in 10MW
Time Frame: Baseline (before surgery), 1, 3 and 12 months after surgery
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Timed 10-meter walk test.
Individual walks without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration.
The test is first performed at preferred walking speed and second at fastest speed possible.
|
Baseline (before surgery), 1, 3 and 12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HHS
Time Frame: Baseline (before surgery), 1, 3 and 12 months after surgery
|
Harris Hip Score.
The HHS is a widely used disease-specific measure of hip disabilities after THA.
The physiotherapist administers the test in the form of a structured interview with the patients.
The domains include pain, functions of daily living and gait.
The rating scale is from 0 (worse) to 100 points (best).
The HHS is considered to have good validity and reliability.
|
Baseline (before surgery), 1, 3 and 12 months after surgery
|
|
SF-36_v2
Time Frame: Baseline (before surgery), 3 and 12 months after surgery
|
36-item short form health survey.
The SF-36v2 is a multipurpose, short-form 36-item health survey yielding a profile of two health component summary measures: psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.
It consists of eight health domain scales: Physical functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE) and Mental Health (MH).
The interpretation of results in simplified with the norm-based scoring (Mean = 50, SD = 10) of its health domain scales and component summary measures.
|
Baseline (before surgery), 3 and 12 months after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Training compliance
Time Frame: First 3 months after surgery
|
Training dairy.
All participants in both groups will keep a training dairy concerning all training activities - they will make marks by every exercise they will perform on exact day, write notes if they will have any other sport activities (walking, stationary bicycling and other) and if there will be any adverse effects, reasons why they skipped training if they did.
They will also measure pain on Visual Analog Scale (VAS) during day before and after training and during night.
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First 3 months after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2018
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
December 23, 2021
Study Registration Dates
First Submitted
July 11, 2019
First Submitted That Met QC Criteria
August 18, 2019
First Posted (Actual)
August 20, 2019
Study Record Updates
Last Update Posted (Actual)
May 3, 2022
Last Update Submitted That Met QC Criteria
April 29, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PRT_PhD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The datasets used and analysed during the current study are and will be available from the corresponding author on reasonable request.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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