Accelerated Rehabilitation in Hip Arthroplasty (ARTHA)

October 2, 2020 updated by: Angela Elizabeth Marchisio, Federal University of Rio Grande do Sul

Accelerated Rehabilitation Versus Conventional Rehabilitation in Total Hip Arthroplasty: A Randomized Double Blinded Clinical Trial

Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR) was designed to improve the functionality and optimize early discharge of patients undergoing THA surgery. This study compared physical therapy protocol in Total Hip Arthroplasty (THA-PT) already deployed in Porto Alegre Clinical Hospital with THA-AR.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 55
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90040-060
        • Federal University Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of the Public Health System of our Country that were admitted with hip osteoarthritis diagnose and submitted to a total hip arthroplasty surgery in the Hospital de Clínicas de Porto Alegre (HCPA).

Exclusion Criteria:

  • Patients who refused to participate in this study;
  • Patients lived in another city;
  • Patients undergoing surgery for total hip arthroplasty due to hip fracture;
  • Patients with cognitive disorders or diseases that adversely affect its cognitive function (Alzheimer's disease, senile dementia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Assistance Protocol-SAP
Patients underwent physical therapy once a day. Patients receive intervention by Physical Therapy-SAP.
Other: Physical Therapy-SAP
  • Day 1) Patients started approach after discharged anesthesia. Patients received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise;
  • Day 2) Patients repeated the exercises learned from day 1. Following the proposed activities patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this second day only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to the next day;
  • Day 3) Patients repeated the day 2. And the patient who had not started gait training in the day 2, began it on the day 3;
  • Day 4 and other days) Patients repeated the gait training until the discharge date.
Active Comparator: Accelerated Rehabilitation Protocol-ARP
Patients underwent physical therapy three times a day. Patients receive intervention by Physical Therapy-ARP.
Other: Physical Therapy-ARP
  • Day 1-1°approach) Patients started after discharged anesthesia. Received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise;
  • Day 1-2°approach) Patients repeated the exercises learned from day 1-1°approach. Following patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this Day 1-2°approach only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to next approach;
  • Day 1-3°approach) Patients repeat the day 1-2°approach. And the patient, who had not started gait training in the day 1 - second approach, began it in this third approach;
  • Day 2) Patients repeated three times the day 1-3°approach;
  • Day 3) Patients repeated three times the day 1-3°approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Merle D'Aubigné and Postel score
Time Frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
From the moment of hospitalization until the day of hospital discharge, assessed up to four days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Muscle strength force
Time Frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Measured based on Kendall's criteria. Measured in the operated hip.
From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Goniometry
Time Frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Evaluate the range of motion in flexion, extension, adduction, abduction, and internal and external rotation in the operated hip.
From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Time to beginning the gait.
Time Frame: From the date of hospitalization until the day that began gait, assessed up to four days.
From the date of hospitalization until the day that began gait, assessed up to four days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Carlos R Galia, Doctor, Federal University Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FederalURS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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