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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

Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
hip-related muscular strength [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
hip-related muscular strength measured with isokinetic dynamometry
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • hip-related muscular strength [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    hip-related muscular strength measured with isokinetic dynamometry
  • hip-related muscular strength [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    hip-related muscular strength measured with isokinetic dynamometry
Change History Complete list of historical versions of study NCT03584451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • 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)
  • Physical function hip - WOMAC [ Time Frame: change from 6 months to 12 months after THA ]
    WOMAC Total Score (worst=0, best=100)
  • Physical function hip - HHS [ Time Frame: change from 6 months to 12 months after THA ]
    Harris-Hip-Score (worst=0, best=100)
  • 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)
  • 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)
  • Hip pain [ Time Frame: change from 6 months to 12 months after THA ]
    Visual Analogue Scale (worst=0, best=10)
  • cardiovascular endurance [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    cardiovascular endurance via lactate measurements
  • cardiovascular endurance [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    cardiovascular endurance via lactate measurements
  • postural control [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    postural control with a force measuring platform
  • postural control [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    postural control with a force measuring platform
  • hip-related muscular strength [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    hip-related muscular strength measured with isokinetic dynamometry
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Hip pain [ 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)
  • Physical function hip - WOMAC [ Time Frame: change from 6 months to 12 months after THA ]
    WOMAC Total Score (worst=0, best=100)
  • Physical function hip - HHS [ Time Frame: change from 6 months to 12 months after THA ]
    Harris-Hip-Score (worst=0, best=100)
  • 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)
  • 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)
  • Satisfaction with THA [ Time Frame: 12 months after THA ]
    Visual Analoge Scale (worst=0, best=10)
  • cardiovascular endurance [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    cardiovascular endurance via lactate measurements
  • cardiovascular endurance [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    cardiovascular endurance via lactate measurements
  • postural control [ Time Frame: change from baseline (6 weeks) at 6 months after THA ]
    postural control with a force measuring platform
  • postural control [ Time Frame: change from baseline (6 weeks) at 12 months after THA ]
    postural control with a force measuring platform
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of Rehabilitation Sport After Total Hip Arthroplasty (THA)
Official Title  ICMJE Randomized, Clinical Survey for Evaluating the Effect of Rehabilitation Sport on Patients Who Underwent Total Hip Arthroplasty (THA)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Total Hip Arthroplasty
  • Osteoarthritis, Hip
  • Sports Physical Therapy
Intervention  ICMJE Behavioral: rehabilitation sport
rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively
Study Arms  ICMJE
  • Active Comparator: with rehabilitation sport
    rehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively
    Intervention: Behavioral: rehabilitation sport
  • No Intervention: without rehabilitation sport
    no further rehabilitation program after THA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • non-complicated THA
  • written informed consent

Exclusion Criteria:

  • complicated THA
  • partial weight-bearing after surgery
  • cardial comorbidities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584451
Other Study ID Numbers  ICMJE rehasport after THA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share IPD
Responsible Party Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Technische Universität Dresden
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP