NCT01538407

Brief Summary

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

February 20, 2012

Last Update Submit

January 21, 2014

Conditions

Knee Osteoarthritis

Keywords

Strength trainingBiomechanicsQuadricepsGait

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    Baseline and after 12 weeks

  • Change from baseline in knee compressive force during walking at 12 weeks

    Baseline and after 12 weeks

Study Arms (2)

Control group

NO INTERVENTION

No intervention group

Strength training group

ACTIVE COMPARATOR

The knee extension strength training intervention period is 12 weeks with training sessions three times per week.

Other: Strength Training

Interventions

Strength TrainingOTHER

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.

Strength training group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum

Greenville, North Carolina, 27858, United States

Location

The Parker Institute, Frederiksberg University Hospital

Copenhagen, 2000, Denmark

Location

Related Publications (1)

  • 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). 2018 Nov;59:199-206. doi: 10.1016/j.clinbiomech.2018.09.016. Epub 2018 Sep 15.

    PMID: 30273922DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Paul Devita, MSc, PhD

    The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum Greenville, U.S.A.

    PRINCIPAL INVESTIGATOR

  • Marius Henriksen, PhD

    The Parker Institute, Frederiksberg University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, PT. PhD

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(1)DK(1)