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

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ClinicalTrials.gov Identifier: NCT03584451
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

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.

Condition or disease Intervention/treatment Phase
Total Hip Arthroplasty Osteoarthritis, Hip Sports Physical Therapy Behavioral: rehabilitation sport Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Clinical Survey for Evaluating the Effect of Rehabilitation Sport on Patients Who Underwent Total Hip Arthroplasty (THA)
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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



Primary Outcome Measures :
  1. hip-related muscular strength [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    hip-related muscular strength measured with isokinetic dynamometry


Secondary Outcome Measures :
  1. Hip pain - WOMAC [ Time Frame: change from 6 months to 12 months after THA ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (worst=0, best=100)

  2. Physical function hip - WOMAC [ Time Frame: change from 6 months to 12 months after THA ]
    WOMAC Total Score (worst=0, best=100)

  3. Physical function hip - HHS [ Time Frame: change from 6 months to 12 months after THA ]
    Harris-Hip-Score (worst=0, best=100)

  4. Physical Activity [ Time Frame: change from 6 months to 12 months after THA ]
    University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)

  5. health related Quality of life [ Time Frame: change from 6 months to 12 months after THA ]
    EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1), EQ-VAS (worst=0, best=100)

  6. Hip pain [ Time Frame: change from 6 months to 12 months after THA ]
    Visual Analogue Scale (worst=0, best=10)

  7. cardiovascular endurance [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    cardiovascular endurance via lactate measurements

  8. cardiovascular endurance [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    cardiovascular endurance via lactate measurements

  9. postural control [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    postural control with a force measuring platform

  10. postural control [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    postural control with a force measuring platform

  11. hip-related muscular strength [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    hip-related muscular strength measured with isokinetic dynamometry



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non-complicated THA
  • written informed consent

Exclusion Criteria:

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

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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT03584451     History of Changes
Other Study ID Numbers: rehasport after THA
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases