Strengthening Exercise and Quadriceps Force During Walking

This study has been completed.
Sponsor:
Collaborator:
East Carolina University
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01538407
First received: February 20, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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 Intervention
Knee Osteoarthritis
Other: Strength Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Study of Strengthening Exercise on Quadriceps Force During Walking

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Change from baseline in peak quadriceps force during walking at 12 weeks [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Estimates of the quadriceps muscle forces during locomotion are calculated using a biomechanical model based on data from gait analysis


Secondary Outcome Measures:
  • Change from baseline in quadriceps power and work during walking at 12 weeks [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
    Estimated from gait analysis

  • Change from baseline in knee compressive force during walking at 12 weeks [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
    Estimated from biomechanical modelling of data from gait analysis


Enrollment: 30
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A medical doctor will perform the screening of potential participants. Subjects must meet the following inclusion criteria to be eligible for study entry:

  • Knee OA diagnosed according to the American College of Rheumatology criteria (26), with clinical symptoms and radiographically verified tibio-femoral osteoarthritis in one or both knees.
  • Aged between 40 and 65 yrs.
  • Untrained (i.e. less than 2 hours of exercise per week)
  • Subject must not be using assistive walking device
  • Willing and able to complete study visits and procedures
  • Willing to hold activity and exercise level generally consistent during the study except that encompassed in the study.
  • In general good health, in the opinion of the investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the medical doctor at the screening visit.
  • A body mass index (BMI) of 19<BMI≤32kg/m2
  • Speaks, reads and writes Danish and/or English language

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria will be ineligible for study entry:

  • Subjects depending on walking device
  • Pregnant or breastfeeding
  • Radiographic evidence of Patello-femoral knee OA only (and no tibio-femoral OA).
  • History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis)
  • Planned surgical procedure during the duration of the study
  • History or diagnosis of musculoskeletal injuries or pathologies, including but not limited to:

    • Anterior cruciate ligament injuries
    • Meniscal injuries related to trauma (degenerative changes allowed)
    • Patellofemoral Pain Syndrome
    • Low back pain
  • History, diagnosis, or signs and symptoms of clinically significant cardiovascular disease, including but not limited to:

    • Ischemic heart disease
    • Arthrosclerosis
    • Peripheral artery disease
  • History, diagnosis, or signs and symptoms of diabetes
  • History, diagnosis, or signs and symptoms of neurological disorders including but not limited to

    • Stroke
    • Parkinson's disease
    • Multiple sclerosis
  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: NCT01538407

Locations
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
Denmark
The Parker Institute, Frederiksberg University Hospital
Copenhagen, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
East Carolina University
Investigators
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
  More Information

No publications provided

Responsible Party: Marius Henriksen, Senior Researcher, PT. PhD, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01538407     History of Changes
Other Study ID Numbers: 117.0
Study First Received: February 20, 2012
Last Updated: January 21, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Frederiksberg University Hospital:
Strength training
Biomechanics
Quadriceps
Gait

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

ClinicalTrials.gov processed this record on September 18, 2014