ArthroplastyNCT04061993
Effects of Early Home-based Strength and Sensory-motor Training After THA on Functional Outcome and Patient Satisfaction
A study testing Strength and Sensory-Motor Training and Current Standard Physiotherapy in people with Arthroplasty and Replacement, run by Valdoltra Orthopedic Hospital at 2 sites in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Strength and Sensory-Motor Training and Current Standard Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSlovenia
- Study dates
- 9 Jan 2018to 23 Dec 2021
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Valdoltra Orthopaedic Hospital
Ankaran, 6280
General Hospital Novo mesto
Novo Mesto, 8000
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthroplasty, Replacement, Hip, Strength Training
- Being tested
- Strength and Sensory-Motor Training, Current Standard Physiotherapy
- Keywords
- Total hip arthroplasty, Early postoperative exercise, Home-based training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength and Sensory-Motor TrainingProcedure or surgery
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).
Current Standard PhysiotherapyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group OBV | Experimental | 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. Receives: Procedure: Strength and Sensory-Motor Training; Procedure: Current Standard Physiotherapy |
| Control Group OBV | Active comparator | 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. Receives: Procedure: Current Standard Physiotherapy |
| Intervention Group SBNM | Experimental | 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. Receives: Procedure: Strength and Sensory-Motor Training; Procedure: Current Standard Physiotherapy |
| Control Group SBNM | Active comparator | 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. Receives: Procedure: Current Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isometric hip and trunk muscles strength
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).
Measured: Baseline (before surgery), 1, 3 and 12 months after surgery
Change in 8UG
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.
Measured: Baseline (before surgery), 1, 3 and 12 months after surgery
Change in 10MW
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.
Measured: Baseline (before surgery), 1, 3 and 12 months after surgery
Secondary outcomes (2)
HHS
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.
Measured: Baseline (before surgery), 1, 3 and 12 months after surgery
SF-36_v2
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.
Measured: Baseline (before surgery), 3 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start9 Jan 2018
- Primary completion1 Jul 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valdoltra Orthopedic Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061993
- Sponsor's protocol ID
- PRT_PhD
- Status last verified
- Apr 2022
- First submitted
- 11 Jul 2019
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and analysed during the current study are and will be available from the corresponding author on reasonable request.
Publications
Kristof Mirt P, Strojnik V, Kavcic G, Trebse R. Effects of early home-based strength and sensory-motor training after total hip arthroplasty: study protocol for a multicenter randomized controlled trial. Trials. 2022 Nov 8;23(1):929. doi: 10.1186/s13063-022-06779-8.
PubMed 36348372
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Home-based Strength and Sensory-motor Training After Total Hip Arthroplasty: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04061993
- Acronym / sponsor ID
- PRT_PhD
- Conditions
- Arthroplasty, Replacement, Hip, Strength Training
- Keywords
- Total hip arthroplasty, Early postoperative exercise, Home-based training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Valdoltra Orthopedic HospitalUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Group OBV | Experimental | Procedure: Strength and Sensory-Motor Training, Procedure: Current Standard PhysiotherapyIntervention 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. |
| Control Group OBV | Active comparator | Procedure: Current Standard PhysiotherapyControl 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. |
| Intervention Group SBNM | Experimental | Procedure: Strength and Sensory-Motor Training, Procedure: Current Standard PhysiotherapyIntervention 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. |
| Control Group SBNM | Active comparator | Procedure: Current Standard PhysiotherapyControl 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength and Sensory-Motor TrainingEarly 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). | Procedure or surgery | Intervention Group OBV, Intervention Group SBNM |
| Current Standard PhysiotherapyMobilisation 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 | Procedure or surgery | Control Group OBV, Control Group SBNM, Intervention Group OBV, Intervention Group SBNM |
Primary outcome
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).
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.
Change in 10MW
Time frame: Baseline (before surgery), 1, 3 and 12 months after surgery
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.
2 secondary outcomes
HHS
Time frame: Baseline (before surgery), 1, 3 and 12 months after surgery
SF-36_v2
Time frame: Baseline (before surgery), 3 and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Derived from this study: PubMed 36348372Kristof Mirt P, Strojnik V, Kavcic G, Trebse R. Effects of early home-based strength and sensory-motor training after total hip arthroplasty: study protocol for a multicenter randomized controlled trial. Trials. 2022 Nov 8;23(1):929. doi: 10.1186/s13063-022-06779-8.
- Individual participant dataSharing planned: Yes. The datasets used and analysed during the current study are and will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength and Sensory-Motor Training and Current Standard Physiotherapy in people with Arthroplasty and Replacement, run by Valdoltra Orthopedic Hospital at 2 sites in Slovenia.
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 5 inclusion and 4 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in isometric hip and trunk muscles strength (time frame: Baseline (before surgery), 1, 3 and 12 months after surgery). 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 NCT04061993, 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 3 May 2022.