Evaluation of the Effect of Rehabilitation Sport After Total Hip Arthroplasty (THA)

Study Overview
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Brief Summary
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160 patients who received a total hip arthroplasty (THA) were included and randomized to receive specific rehabilitation sport (RS) or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements.

Detailed Description
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In Germany, rehabilitation sport (RS) is a reimbursed postoperative measure in order to support socio-professional reintegration and self-help. 160 patients who received a primary total hip arthroplasty (THA) were included and randomized to receive specific RS or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements. The goal of the study was to prospectively randomized evaluate the effect of RS on hip-related muscular strength, endurance and postural stability on patients who underwent THA.

Official Title
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Randomized, Clinical Survey for Evaluating the Effect of Rehabilitation Sport on Patients Who Underwent Total Hip Arthroplasty (THA)

Conditions
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Total Hip Arthroplasty, Osteoarthritis, Hip, Sports Physical Therapy

Intervention / Treatment
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* Behavioral: rehabilitation sport


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-complicated THA written informed consent Exclusion Criteria: complicated THA partial weight-bearing after surgery cardial comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with rehabilitation sport<br>rehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively | Behavioral: rehabilitation sport<br>* rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively<br>|
| No Intervention: without rehabilitation sport<br>no further rehabilitation program after THA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip-related muscular strength | hip-related muscular strength measured with isokinetic dynamometry | change from baseline (6 weeks) at 6 months after THA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip pain - WOMAC | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (worst=0, best=100) | change from 6 months to 12 months after THA | 
| Physical function hip - WOMAC | WOMAC Total Score (worst=0, best=100) | change from 6 months to 12 months after THA | 
| Physical function hip - HHS | Harris-Hip-Score (worst=0, best=100) | change from 6 months to 12 months after THA | 
| Physical Activity | University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10) | change from 6 months to 12 months after THA | 
| health related Quality of life | EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1), EQ-VAS (worst=0, best=100) | change from 6 months to 12 months after THA | 
| Hip pain | Visual Analogue Scale (worst=0, best=10) | change from 6 months to 12 months after THA | 
| cardiovascular endurance | cardiovascular endurance via lactate measurements | change from baseline (6 weeks) at 6 months after THA | 
| cardiovascular endurance | cardiovascular endurance via lactate measurements | change from baseline (6 weeks) at 12 months after THA | 
| postural control | postural control with a force measuring platform | change from baseline (6 weeks) at 6 months after THA | 
| postural control | postural control with a force measuring platform | change from baseline (6 weeks) at 12 months after THA | 
| hip-related muscular strength | hip-related muscular strength measured with isokinetic dynamometry | change from baseline (6 weeks) at 12 months after THA |