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Ergometer Cycling After Replacement of the Hip or Knee Joint

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00951990
Enrollment
457
Registered
2009-08-04
Start date
2005-01-31
Completion date
2008-08-31
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Brief summary

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.

Interventions

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.

BEHAVIORALNo ergometer cycling

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

Sponsors

Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V
CollaboratorOTHER
Landesversicherungsanstalt Schleswig-Holstein
CollaboratorUNKNOWN
Landesversicherungsanstalt Freie und Hansestadt Hamburg
CollaboratorUNKNOWN
Deutsche Arthrose-Hilfe
CollaboratorOTHER
Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
WOMAC Physical Function3 months to 24 months

Secondary

MeasureTime frame
WOMAC Pain and Stiffness3 months to 24 months
SF-363 months to 24 months
Patient satisfaction3 months to 24 months
Lequesne Hip or Knee Score3 months to 24 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026