Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement

NCT01345825 | Completed Phase 3 DMC

• 1 other identifier: M-20100185
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

osteoarthrosis; unicompartmental knee replacement; knee; resistance training; Muscle power; gait analysis; gait; physiotherapy; Gyro sensor

Outcome Measures

Primary Outcomes (1)

• Muscle power test (by a power rig)

  prior to operation (baseline), 9 weeks post operativ and 1 year post operative

Secondary Outcomes (1)

• Gait quality

  prior to operation (baseline), 9 weeks post operativ and 1 year post operative

Study Arms (1)

resistance training

EXPERIMENTAL

Other: Resistance training

Interventions

Resistance training OTHER

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

resistance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kjeld Søballe

  Orthopaedic Surgery Research Unit, Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2014
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

DK (1)