Exercises in the Post-operative Rehabilitation of THA

April 4, 2020 updated by: Bruna de Moraes Lopes, Federal University of Health Science of Porto Alegre

Effects of an Exercise Program Based on Muscle Strengthening in the Rehabilitation of Individuals Undergoing Total Hip Arthroplasty: a Randomized Clinical Trial.

Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Individuals with osteoarthritis (OA) of the hip submitted to total hip arthroplasty (THA) may present alterations in their functional capacity, and associated, among other aspects, the reduction in muscle strength. Our overall objective is to compare the effects of an exercise program based on training of muscular strength to orientations and functional home exercises in patients submitted to THA, as well as to compare the outcomes of both groups with those of healthy individuals. Individuals with THA will be randomly assigned to two groups. One group will receive face-to-face treatment (G1) and the other will receive postoperative guidance (G2). A blinded appraiser regarding the allocation will apply the evaluation tools at the moments: preintervention, after completing 7 days and after 10 weeks of the end of the treatment. The research will present as clinical outcomes: the muscular strength, through the values of torque peaks obtained in dynamometry; the functional capacity through the results of the Timed Up and Go test and the Harris Hip Score questionnaire; the range of joint motion measured with and flexometer; the pain through the results of the numerical scale of pain; and kinesiophobia, through the scores obtained in the Tampa Scale.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
  • Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
  • Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.

Exclusion Criteria:

  • Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
  • previous surgical procedures in the coxofemoral joint;
  • surgical procedures and osteoarticular diseases in the lumbar spine;
  • osteoarticular diseases in lower limb joints;
  • muscle injuries in lower limbs;
  • presence of signs or symptoms of osteoarthritis in the contralateral hip;
  • postoperative complications such as prosthesis dislocation, deep venous thrombosis, periarticular fractures and neural lesions;
  • intra-articular injection of corticosteroids in the lower limbs during the last six months;
  • cardiovascular diseases with presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
  • presence of neurological diseases.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Rehabilitation Exercises Group 1 will be submitted to an exercise protocol based on muscle strength training, with duration of 6 weeks and frequency of two weekly sessions, lasting 45 minutes.
Other: Rehabilitation exercises
Patients in group 1 will participate in a physical exercise protocol supervised by a physiotherapist. The sessions will focus on the rehabilitation of muscle strength and the exercises will be performed with increased external load.
Active Comparator: Group 2
Postoperative guidance Group 2 will receive an orientation booklet and weekly links from researchers to address possible questions.
Other: Postoperative guidance
Group 2 will receive only guidelines regarding postoperative care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6 Weeks Post-Intervention Muscle Strength
Time Frame: Will be measured post intervention 6 weeks after intervention).
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Will be measured post intervention 6 weeks after intervention).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Capacity (TUG)
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Functional capacity will be evaluated through the timed up and go test.
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Functional Capacity (HHS)
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Functional capacity will be evaluated through the harris hip score questionnaire.
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Hip Range of Motion
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Hip range of motion will be measured with a flexometer and presented in degrees of movement.
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Pain in the operated hip (last seven days)
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
The patient will be asked about pain felt in the operated hip within the last 7 days. Pain will be assessed with the numeric pain scale and will be represented by the number selected by the patient.
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
1 Week Post-Intervention Muscle Strength
Time Frame: Will be measured post intervention (1 week after intervention).
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Will be measured post intervention (1 week after intervention).
Pre-Intervention Muscle Strength
Time Frame: Will be measured pre-intervention (30 days after the surgery).
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m)
Will be measured pre-intervention (30 days after the surgery).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Body mass index will be acquired by measuring weight and height, and presented in form of the equation mass/height².
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Length of Lower Limbs
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Length of lower limbs will be performed through a tape measure and presented in centimeters.
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Kinesiophobia
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
For the evaluation of the kinesiophobia will be used the Tampa Scale.
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Femoral Offset
Time Frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Evaluation of femoral vertical and horizontal offset, using radiography exams.
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruna M Lopes, PhD Student, Federal Health Science University of Porto Alegre

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THA Rehabilitation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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