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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip; Sports Physical Therapy; Total Hip Arthroplasty
• Intervention / Treatment: Behavioral: rehabilitation sport

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• non-complicated THA
• written informed consent

Exclusion Criteria:

• complicated THA
• partial weight-bearing after surgery
• cardial comorbidities

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: rehasport after THA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No