Exercises in the Post-operative Rehabilitation of THA

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03208829
• Other study ID #: THA Rehabilitation
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: Federal University of Health Science of Porto Alegre
• Contact: Bruna M Lopes, PhD Student
• Phone: +5551993276096
• Email: blopes.fisio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.
• Postoperative guidance
Group 2 will receive only guidelines regarding postoperative care.

Locations

Country	Name	City	State
Brazil	Federal Health Science University of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	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).
Other	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).
Other	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).