Effects of Early Home-based Strength and Sensory-motor Training After THA on Functional Outcome and Patient Satisfaction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Early Home-based Strength and Sensory-motor Training After Total Hip Arthroplasty: a Randomised Controlled Trial

Conditions
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Arthroplasty, Replacement, Hip, Strength Training

Intervention / Treatment
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* Procedure: Strength and Sensory-Motor Training
* Procedure: Current Standard Physiotherapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group OBV<br>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. | Procedure: Strength and Sensory-Motor Training<br>* 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).<br>Procedure: Current Standard Physiotherapy<br>* 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<br>|
| Active Comparator: Control Group OBV<br>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. | Procedure: Current Standard Physiotherapy<br>* 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<br>|
| Experimental: Intervention Group SBNM<br>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. | Procedure: Strength and Sensory-Motor Training<br>* 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).<br>Procedure: Current Standard Physiotherapy<br>* 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<br>|
| Active Comparator: Control Group SBNM<br>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. | Procedure: Current Standard Physiotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | Baseline (before surgery), 1, 3 and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (before surgery), 3 and 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip arthroplasty, Early postoperative exercise, Home-based training