Strengthening Exercise and Quadriceps Force During Walking

A Study of Strengthening Exercise on 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).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Strength Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2000
    • The Parker Institute, Frederiksberg University Hospital
• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in peak quadriceps force during walking at 12 weeks	Estimates of the quadriceps muscle forces during locomotion are calculated using a biomechanical model based on data from gait analysis	Baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in quadriceps power and work during walking at 12 weeks	Estimated from gait analysis	Baseline and after 12 weeks
Change from baseline in knee compressive force during walking at 12 weeks	Estimated from biomechanical modelling of data from gait analysis	Baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Collaborators: 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

Publications and helpful links

General Publications

• DeVita P, Aaboe J, Bartholdy C, Leonardis JM, Bliddal H, Henriksen M. Quadriceps-strengthening exercise and quadriceps and knee biomechanics during walking in knee osteoarthritis: A two-centre randomized controlled trial. Clin Biomech (Bristol, Avon). 2018 Nov;59:199-206. doi: 10.1016/j.clinbiomech.2018.09.016. Epub 2018 Sep 15.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 20, 2012
• First Posted (Estimate): February 24, 2012

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 21, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Gait; Biomechanics; Strength training; Quadriceps
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 117.0