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NCT Number: NCT01538407

Strengthening Exercise and Quadriceps Force During Walking

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).

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Parker Institute, Frederiksberg University Hospital, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength training

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline in quadriceps power and work during walking at 12 weeks

    Time frame: Baseline and after 12 weeks

    Estimated from gait analysis

  2. 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

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Collaborators

  • East Carolina University

Registry information

Official study title

A Study of Strengthening Exercise on Quadriceps Force During Walking

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2012
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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