Clinical trial NCT03208829: Exercises in the Post-operative Rehabilitation of THA
Official title: Effects of an Exercise Program Based on Muscle Strengthening in the Rehabilitation of Individuals Undergoing Total Hip Arthroplasty: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with total hip arthroplasty, will be assigned to two different treatment groups.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6 Weeks Post-Intervention Muscle Strength
timeFrame: Will be measured post intervention 6 weeks after intervention).
Secondary outcomes:
measure: Functional Capacity (TUG)
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
measure: Functional Capacity (HHS)
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
measure: Hip Range of Motion
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
measure: Pain in the operated hip (last seven days)
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
measure: 1 Week Post-Intervention Muscle Strength
timeFrame: Will be measured post intervention (1 week after intervention).
measure: Pre-Intervention Muscle Strength
timeFrame: Will be measured pre-intervention (30 days after the surgery).
Other outcomes:
measure: Body Mass Index
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
measure: Length of Lower Limbs
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
measure: Kinesiophobia
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
measure: Femoral Offset
timeFrame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Locations:
city: Porto Alegre
country: Brazil
facility: Federal Health Science University of Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal Health Science University of Porto Alegre
name: Bruna M Lopes, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: