Exercises in the Post-operative Rehabilitation of THA

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: Unknown
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Other: Rehabilitation exercises; Other: Postoperative guidance

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: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
      • Recruiting
      • Federal Health Science University of Porto Alegre
      • Contact: Marcelo F Silva, PhD; Email: marcelofs@ufcspa.edu.br
      • Contact: Bruno M Baroni, PhD; Email: bruno.baroni@yahoo.com.br
      • Sub-Investigator: Bruna M Lopes, PhD student

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
6 Weeks Post-Intervention Muscle Strength	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

Outcome Measure	Measure Description	Time Frame
Functional Capacity (TUG)	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)	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	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)	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	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	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

Outcome Measure	Measure Description	Time Frame
Body Mass Index	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	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	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	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

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Bruna M Lopes, PhD Student, Federal Health Science University of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 1, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID 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