NCT04061993

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

3.5 years

First QC Date

July 11, 2019

Last Update Submit

April 29, 2022

Conditions

ArthroplastyReplacementHipStrength Training

Keywords

Total hip arthroplastyEarly postoperative exerciseHome-based training

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • HHS

    Baseline (before surgery), 1, 3 and 12 months after surgery

  • SF-36_v2

    Baseline (before surgery), 3 and 12 months after surgery

Other Outcomes (1)

  • Training compliance

    First 3 months after surgery

Study Arms (4)

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.

Procedure: Strength and Sensory-Motor TrainingProcedure: 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.

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.

Procedure: Strength and Sensory-Motor TrainingProcedure: 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.

Procedure: Current Standard Physiotherapy

Interventions

Strength and Sensory-Motor TrainingPROCEDURE

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).

Intervention Group OBVIntervention Group SBNM
Current Standard PhysiotherapyPROCEDURE

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

Control Group OBVControl Group SBNMIntervention Group OBVIntervention Group SBNM

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Valdoltra Orthopaedic Hospital

Ankaran, 6280, Slovenia

Location

General Hospital Novo mesto

Novo Mesto, 8000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 36348372DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

August 20, 2019

Study Start

January 9, 2018

Primary Completion

July 1, 2021

Study Completion

December 23, 2021

Last Updated

May 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

The datasets used and analysed during the current study are and will be available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

SL(2)