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CompletedNCT00951990Updated Apr 6, 2016

Ergometer Cycling After Replacement of the Hip or Knee Joint

A Phase 1/2 interventional study of Ergometer Cycling and No ergometer cycling in Osteoarthritis, sponsored by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein. Completed at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
457
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis

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03

In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 457 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
457 participants (actual)

Interventions

  • BehavioralErgometer Cycling

    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

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What researchers measure

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

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Study locations

5 sites
  • Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery
    Bad Bramstedt, 24576, Germany
  • Ostseeklinik Damp, Department I of Orthopedic Surgery
    Damp, 24351, Germany
  • University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery
    Kiel, 24105, Germany
  • University of Schleswig-Holstein Medical Center, Lübeck Campus
    Lübeck, 23538, Germany
  • Wedel Hospital, Department of Surgery
    Wedel, 22880, Germany
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References and documents

Publications

  • Liebs TR, Nasser L, Herzberg W, Ruther W, Hassenpflug J. The influence of femoral offset on health-related quality of life after total hip replacement. Bone Joint J. 2014 Jan;96-B(1):36-42. doi: 10.1302/0301-620X.96B1.31530. PubMed 24395308 ↗
  • Liebs TR, Herzberg W, Gluth J, Ruther W, Haasters J, Russlies M, Hassenpflug J. Using the patient's perspective to develop function short forms specific to total hip and knee replacement based on WOMAC function items. Bone Joint J. 2013 Feb;95-B(2):239-43. doi: 10.1302/0301-620X.95B2.28383. PubMed 23365035 ↗
  • Liebs TR, Herzberg W, Roth-Kroeger AM, Ruther W, Hassenpflug J. Women recover faster than men after standard knee arthroplasty. Clin Orthop Relat Res. 2011 Oct;469(10):2855-65. doi: 10.1007/s11999-011-1921-z. Epub 2011 Jun 23. PubMed 21698485 ↗
  • Liebs TR, Kloos SA, Herzberg W, Ruther W, Hassenpflug J. The significance of an asymmetric extension gap on routine radiographs after total knee replacement: A new sign and its clinical significance. Bone Joint J. 2013 Apr;95-B(4):472-7. doi: 10.1302/0301-620X.95B4.31080. PubMed 23539698 ↗
  • Liebs TR, Herzberg W, Ruther W, Haasters J, Russlies M, Hassenpflug J. Ergometer cycling after hip or knee replacement surgery: a randomized controlled trial. J Bone Joint Surg Am. 2010 Apr;92(4):814-22. doi: 10.2106/JBJS.H.01359. PubMed 20360503 ↗
  • Liebs TR, Herzberg W, Ruther W, Russlies M, Hassenpflug J; Multicenter Arthroplasty Aftercare Project, MAAP. Quality-Adjusted Life Years Gained by Hip and Knee Replacement Surgery and Its Aftercare. Arch Phys Med Rehabil. 2016 May;97(5):691-700. doi: 10.1016/j.apmr.2015.12.021. Epub 2016 Jan 11. PubMed 26792619 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00951990
Lead sponsor
Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Collaborators
Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V, Landesversicherungsanstalt Schleswig-Holstein, Landesversicherungsanstalt Freie und Hansestadt Hamburg, Deutsche Arthrose-Hilfe
First posted
Aug 4, 2009
Start date
Jan 2005
Primary completion
Apr 2006
Completion
Aug 2008
Last update
Apr 6, 2016

Study contacts

Joachim Hassenpflug, PhD
study chair · University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery, Kiel Campus, 24105 Kiel, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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