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

Primary Purpose

Total Hip Arthroplasty, Osteoarthritis, Hip, Sports Physical Therapy

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

rehabilitation sport

About this trial

This is an interventional treatment trial for Total Hip Arthroplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

non-complicated THA
written informed consent

Exclusion Criteria:

complicated THA
partial weight-bearing after surgery
cardial comorbidities

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

with rehabilitation sport

without rehabilitation sport

Arm Description

rehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively

no further rehabilitation program after THA

Outcomes

Primary Outcome Measures

hip-related muscular strength

hip-related muscular strength measured with isokinetic dynamometry

Secondary Outcome Measures

Hip pain - WOMAC

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (worst=0, best=100)

Physical function hip - WOMAC

WOMAC Total Score (worst=0, best=100)

Physical function hip - HHS

Harris-Hip-Score (worst=0, best=100)

Physical Activity

University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)

health related Quality of life

EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1), EQ-VAS (worst=0, best=100)

Hip pain

Visual Analogue Scale (worst=0, best=10)

cardiovascular endurance

cardiovascular endurance via lactate measurements

cardiovascular endurance

cardiovascular endurance via lactate measurements

postural control

postural control with a force measuring platform

postural control

postural control with a force measuring platform

hip-related muscular strength

hip-related muscular strength measured with isokinetic dynamometry

Full Information

NCT ID

NCT03584451

First Posted

June 4, 2018

Last Updated

August 16, 2018

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT03584451

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technische Universität Dresden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Total Hip Arthroplasty, Osteoarthritis, Hip, Sports Physical Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

with rehabilitation sport

Arm Type

Active Comparator

Arm Description

rehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively

Arm Title

without rehabilitation sport

Arm Type

No Intervention

Arm Description

no further rehabilitation program after THA

Intervention Type

Behavioral

Intervention Name(s)

rehabilitation sport

Intervention Description

rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively

Primary Outcome Measure Information:

Title

hip-related muscular strength

Description

hip-related muscular strength measured with isokinetic dynamometry

Time Frame

change from baseline (6 weeks) at 6 months after THA

Secondary Outcome Measure Information:

Title

Hip pain - WOMAC

Description

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (worst=0, best=100)

Time Frame