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Completed

NCT Number: NCT04061993

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

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.

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Key information

Conditions

Arthroplasty Hip Replacement Strength Training

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valdoltra Orthopaedic Hospital, Ankaran, Slovenia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Strength and Sensory-Motor Training

Procedure

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 Physiotherapy

Procedure

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

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Valdoltra Orthopedic Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2019
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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