Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01345825
First received: April 29, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose and Study hypotheses:

The purpose of the study is to investigate the effect of progressive resistance training in the early postoperative phase on patients who has had unicompartmental knee replacement. The hypotheses are that this group compared to a control group will achieve greater muscle strength and functional ability in terms of gait and working capacity.

Study design:

The subjects will be randomized into two groups; intervention and control. Intervention group: strength training two times a week supervised by a physiotherapist.

Control group: Training at home, following extradited guidelines.

Endpoint:

Primary endpoint is two months postoperative. The following test will be used: muscle power test (by a Power Rig), instrumented gait analysis using a combined accelerometer and gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step test.

Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.

Sample size:

The power calculation is based on an expected improvement in muscle power by 25%. The risk of a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that 24 patients are needed in both groups, but 30 patient will be included in both groups to account for dropouts.

Perspectives:

This study is, to our knowledge, the first study to investigate the effect of strength training after unicompartmental knee replacement. Moreover it has , to our knowledge not been. At the moment no guidelines for rehabilitation exist, and research showed that this group of patients has a decreased function in their daily living compared with the background population. If, as expected, cases have an overall increased function compared to controls, this study can provide a basis for future rehabilitation.


Condition Intervention Phase
Knee Osteoarthritis
Other: Resistance training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: The Effectiveness of 8-weeks Progressive Strength Training to Patients With Unicompartmental Knee Replacement, Initiated Within the First Postoperative Week

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Muscle power test (by a power rig) [ Time Frame: prior to operation (baseline), 9 weeks post operativ and 1 year post operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait quality [ Time Frame: prior to operation (baseline), 9 weeks post operativ and 1 year post operative ] [ Designated as safety issue: No ]
    Instrumentet gait analysis using a combined gyro-sensor and accelerometer - inertia measurement unit(IMU).


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resistance training Other: Resistance training
Week 1: 2 sets x 12 repetitions at 12 RM Week 2: 3 sets of 12 repetitions with 12 RM Week 3: 3 sets of 10 repetitions with 10 RM Week 4-5: 3 sets of 10 repetitions with 10 RM Week 6: 3 sets of 8 repetitions with 8 RM Week 7: 4 sets of 8 repetitions with 8 RM Week 8: 4 sets of 8 repetitions with 8 RM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medial osteoarthrosis in knee assigned to unicompartmental knee replacement
  • 18+ years.

Exclusion Criteria:

  • rheumatoid arthritis
  • neuro muscular conditions
  • alcohol or drug abuse
  • cognitive problems
  • patients not fluid in the Danish language
  • walking disability caused by other than in condition in question
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345825

Contacts
Contact: Søren Bie Bogh +45 42343553 sorenbiebogh@gmail.com
Contact: Peter Bo Jørgensen +4524422004 peter.bo@gmail.com

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Søren Bie Bogh       sorenbiebogh@gmail.com   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kjeld Søballe Orthopaedic Surgery Research Unit, Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01345825     History of Changes
Other Study ID Numbers: M-20100185
Study First Received: April 29, 2011
Last Updated: December 6, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
osteoarthrosis
unicompartmental knee replacement
knee
resistance training
Muscle power
gait analysis
gait
physiotherapy
Gyro sensor

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014