Exercises in the Post-operative Rehabilitation of THA

NCT ID: NCT03208829

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-04

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with total hip arthroplasty, will be assigned to two different treatment groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The random allocation step will be conducted through Randomizers - www.random.org by a research assistant. The assistant responsible for randomization will not be involved in any other phase of the study and the secrecy of the allocation will be maintained through opaque envelopes. A second independent assistant will administer the agenda and all communication between the participants and the researchers involved

Study Groups

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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.

Group Type EXPERIMENTAL

Rehabilitation exercises

Intervention Type OTHER

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.

Group 2

Postoperative guidance Group 2 will receive an orientation booklet and weekly links from researchers to address possible questions.

Group Type ACTIVE_COMPARATOR

Postoperative guidance

Intervention Type OTHER

Group 2 will receive only guidelines regarding postoperative care.

Interventions

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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.

Intervention Type OTHER

Postoperative guidance

Group 2 will receive only guidelines regarding postoperative care.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Bruna de Moraes Lopes

Principal Investigator (PhD student)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruna M Lopes, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Federal Health Science University of Porto Alegre

Locations

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Federal Health Science University of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bruna M Lopes, PhD Student

Role: CONTACT

+5551993276096

Marcelo F Silva, PhD

Role: CONTACT

Facility Contacts

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Marcelo F Silva, PhD

Role: primary

Bruno M Baroni, PhD

Role: backup

Other Identifiers

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THA Rehabilitation

Identifier Type: -

Identifier Source: org_study_id

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