An interventional study of Strength and Sensory-Motor Training and Current Standard Physiotherapy in Arthroplasty, Replacement and Hip, sponsored by Valdoltra Orthopedic Hospital. Completed at 2 sites in Slovenia. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Valdoltra Orthopedic Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Valdoltra Orthopedic Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Procedure: Current Standard Physiotherapy
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
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 · Procedure: Current Standard Physiotherapy
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
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
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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline (before surgery), 1, 3 and 12 months after surgery
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.
Time frame: 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.
Time frame: Baseline (before surgery), 3 and 12 months after surgery
Training compliance
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.
Time frame: First 3 months after surgery
Plan to share: Yes — The datasets used and analysed during the current study are and will be available from the corresponding author on reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Valdoltra Orthopedic Hospital