Strengthening Exercise and Quadriceps Force During Walking
|ClinicalTrials.gov Identifier: NCT01538407|
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : January 22, 2014
This is a longitudinal, randomized, controlled interventional multi centric study on the effects of lower leg strengthening exercise on quadriceps force during walking in people with knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40 participants. Subjects will be randomized equally (1:1) into 1 active arm and 1 control arm.
The objective of the study is to evaluate the effect of twelve weeks of quadriceps strengthening on the mechanical output of the quadriceps during locomotion. A secondary purpose is to explore the relationship between quadriceps strengthening and compressive knee loadings. The hypothesis is that quadriceps strength training will not change quadriceps force, power, and work in locomotion in people with knee osteoarthritis.
Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power and work and knee compressive loads during walking. Explorative measures are isometric and concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up test (maximum number of reps).
|Condition or disease||Intervention/treatment|
|Knee Osteoarthritis||Other: Strength Training|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study of Strengthening Exercise on Quadriceps Force During Walking|
|Study Start Date :||March 2012|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
No Intervention: Control group
No intervention group
Active Comparator: Strength training group
The knee extension strength training intervention period is 12 weeks with training sessions three times per week.
Other: Strength Training
The exercises will be performed in standard strength training equipment. Prior to each of the strengthening exercise sessions, a warm up phase is performed by 5-10 minutes of ergometer cycling at a moderate intensity. Muscle strengthening exercises will be performed according to the standard progressive resistance and overload principle. The exercise programme consists of three exercises performed with three sets of 10 repetitions at 60%-85% of patient's 10RM. Training load will be progressed by means of bi-weekly estimates of muscle strength to ensure a constant load of 60%-85% RM. Exercises are: 1. Leg extension, 2. Leg press, and 3. Forward lunges.
- Change from baseline in peak quadriceps force during walking at 12 weeks [ Time Frame: Baseline and at 12 weeks ]Estimates of the quadriceps muscle forces during locomotion are calculated using a biomechanical model based on data from gait analysis
- Change from baseline in quadriceps power and work during walking at 12 weeks [ Time Frame: Baseline and after 12 weeks ]Estimated from gait analysis
- Change from baseline in knee compressive force during walking at 12 weeks [ Time Frame: Baseline and after 12 weeks ]Estimated from biomechanical modelling of data from gait analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538407
|United States, North Carolina|
|The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum|
|Greenville, North Carolina, United States, 27858|
|The Parker Institute, Frederiksberg University Hospital|
|Copenhagen, Denmark, 2000|
|Principal Investigator:||Paul Devita, MSc, PhD||The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum Greenville, U.S.A.|
|Study Director:||Marius Henriksen, PhD||The Parker Institute, Frederiksberg University Hospital|