Strengthening Exercise and Quadriceps Force During Walking

NCT ID: NCT01538407

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

No intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Strength training group

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

Group Type ACTIVE_COMPARATOR

Strength Training

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

East Carolina University

OTHER

Sponsor Role collaborator

Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marius Henriksen

Senior Researcher, PT. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Devita, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Marius Henriksen, PhD

Role: STUDY_DIRECTOR

The Parker Institute, Frederiksberg University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Greenville, North Carolina, United States

Site Status

The Parker Institute, Frederiksberg University Hospital

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30273922 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

117.0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.