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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584451
• Other study ID #: rehasport after THA
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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