Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04061993
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Valdoltra Orthopedic Hospital

Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE January 9, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Early Home-based Strength and Sensory-motor Training After THA on Functional Outcome and Patient Satisfaction
Official Title  ICMJE Effects of Early Home-based Strength and Sensory-motor Training After Total Hip Arthroplasty: a Randomised Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Arthroplasty
  • Replacement
  • Hip
  • Strength Training
Intervention  ICMJE
  • Procedure: 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).
  • Procedure: Current Standard Physiotherapy
    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 Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Strength and Sensory-Motor Training
    • Procedure: Current Standard Physiotherapy
  • 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.
    Intervention: Procedure: Current Standard Physiotherapy
  • 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.
    Interventions:
    • Procedure: Strength and Sensory-Motor Training
    • Procedure: Current Standard Physiotherapy
  • 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.
    Intervention: Procedure: Current Standard Physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients undergoing elective primary unilateral THA for OA.
  2. Patients older than 60 years at the time of surgery.
  3. Ability to watch exercise videos on USB drive.
  4. American Society of Anaesthesiologists (ASA) Classification 1-3.
  5. Patients are able to consent and willing to comply with the study protocol.

Exclusion Criteria:

  1. Primary THA for a diagnosis other than OA (aseptic femoral head necrosis, dysplastic hip…) or revision THA.
  2. Patients having previous hip interventions (osteosynthesis, osteotomy…)
  3. Discharge to rehabilitation units or nursing homes.
  4. 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rihard Trebše +386 (0)5 6696 341 rihard.trebse@ob-valdoltra.si
Contact: Pika Krištof Mirt pikamirt@gmail.com
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04061993
Other Study ID Numbers  ICMJE PRT_PhD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The datasets used and analysed during the current study are and will be available from the corresponding author on reasonable request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Valdoltra Orthopedic Hospital
Study Sponsor  ICMJE Valdoltra Orthopedic Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Valdoltra Orthopedic Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP