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Completed

NCT Number: NCT03584451

Evaluation of the Effect of Rehabilitation Sport After 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.

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Key information

Conditions

Total Hip Arthroplasty Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases Sports Physical Therapy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non-complicated THA
  • written informed consent

Exclusion criteria

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

Treatment and study plan

rehabilitation sport

Behavioral

rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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