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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03584451
Other study ID # rehasport after THA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date December 2017

Study information

Verified date August 2018
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- non-complicated THA

- written informed consent

Exclusion Criteria:

- complicated THA

- partial weight-bearing after surgery

- cardial comorbidities

Study Design


Intervention

Behavioral:
rehabilitation sport
rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Outcome

Type Measure Description Time frame Safety issue
Primary hip-related muscular strength hip-related muscular strength measured with isokinetic dynamometry change from baseline (6 weeks) at 6 months after THA
Secondary 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
Secondary Physical function hip - WOMAC WOMAC Total Score (worst=0, best=100) change from 6 months to 12 months after THA
Secondary Physical function hip - HHS Harris-Hip-Score (worst=0, best=100) change from 6 months to 12 months after THA
Secondary Physical Activity University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10) change from 6 months to 12 months after THA
Secondary 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
Secondary Hip pain Visual Analogue Scale (worst=0, best=10) change from 6 months to 12 months after THA
Secondary cardiovascular endurance cardiovascular endurance via lactate measurements change from baseline (6 weeks) at 6 months after THA
Secondary cardiovascular endurance cardiovascular endurance via lactate measurements change from baseline (6 weeks) at 12 months after THA
Secondary postural control postural control with a force measuring platform change from baseline (6 weeks) at 6 months after THA
Secondary postural control postural control with a force measuring platform change from baseline (6 weeks) at 12 months after THA
Secondary hip-related muscular strength hip-related muscular strength measured with isokinetic dynamometry change from baseline (6 weeks) at 12 months after THA
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