Skip to main content
OpenTrials
Completed

NCT Number: NCT00951990

Ergometer Cycling After Replacement of the Hip or Knee Joint

Despite the widespread use of hip and knee replacement surgery, there is a considerable lack of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices.

In particular there are no recommendations regarding the use of ergometer cycling after hip or knee replacement surgery.

Therefore the investigators initiated a multicenter controlled clinical trial evaluating the effect of ergometer cycling versus no ergometer cycling after hip or knee replacement surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery, Bad Bramstedt, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis of diagnosis of osteoarthritis or femoral head necrosis

Exclusion criteria

  • A history of septic arthritis
  • Hip fracture
  • Intraoperative complications
  • History of implant surgery on the joint to be operated on
  • Rheumatoid arthritis
  • Amputations
  • Inability of complete the questionnaires because of cognitive or language difficulties

Treatment and study plan

Ergometer Cycling

Behavioral

Ergometer Cycling under the guidance of a physical therapist after the second postoperative week. These training sessions were scheduled to be performed three times a week for a time period of at least three weeks. The resistance of the ergometer was set to a minimum (for example 30 Watts). Physical therapists were informed to pay special attention, that the height of the saddle is set so that the forefoot reaches the pedal with the knee in extension.

No ergometer cycling

Behavioral

Patients of the no ergometer cycling group did not receive any ergometer cycling after surgery

Primary outcomes

  1. WOMAC Physical Function

    Time frame: 3 months to 24 months

Secondary outcomes

  1. WOMAC Pain and Stiffness

    Time frame: 3 months to 24 months

  2. SF-36

    Time frame: 3 months to 24 months

  3. Patient satisfaction

    Time frame: 3 months to 24 months

  4. Lequesne Hip or Knee Score

    Time frame: 3 months to 24 months

Sponsors and collaborators

Lead sponsor

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

Other

Collaborators

  • Deutsche Arthrose-Hilfe
  • Landesversicherungsanstalt Freie und Hansestadt Hamburg
  • Landesversicherungsanstalt Schleswig-Holstein
  • Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V

Registry information

Official study title

A Multicenter Randomized Controlled Trail of Ergometer Cycling After Hip and Knee Replacement Surgery

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Aug 4, 2009
Registry last updated
Apr 6, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.