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Strengthening Exercise and Quadriceps Force During Walking

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Strength Training
Sponsored by
Frederiksberg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Osteoarthritis focused on measuring Strength training, Biomechanics, Quadriceps, Gait

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum
  • The Parker Institute, Frederiksberg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Strength training group

Arm Description

No intervention group

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in quadriceps power and work during walking at 12 weeks
Estimated from gait analysis
Change from baseline in knee compressive force during walking at 12 weeks
Estimated from biomechanical modelling of data from gait analysis

Full Information

First Posted
February 20, 2012
Last Updated
January 21, 2014
Sponsor
Frederiksberg University Hospital
Collaborators
East Carolina University
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1. Study Identification

Unique Protocol Identification Number
NCT01538407
Brief Title
Strengthening Exercise and Quadriceps Force During Walking
Official Title
A Study of Strengthening Exercise on Quadriceps Force During Walking
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Frederiksberg University Hospital
Collaborators
East Carolina University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Strength training, Biomechanics, Quadriceps, Gait

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention group
Arm Title
Strength training group
Arm Type
Active Comparator
Arm Description
The knee extension strength training intervention period is 12 weeks with training sessions three times per week.
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in peak quadriceps force during walking at 12 weeks
Description
Estimates of the quadriceps muscle forces during locomotion are calculated using a biomechanical model based on data from gait analysis
Time Frame
Baseline and at 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in quadriceps power and work during walking at 12 weeks
Description
Estimated from gait analysis
Time Frame
Baseline and after 12 weeks
Title
Change from baseline in knee compressive force during walking at 12 weeks
Description
Estimated from biomechanical modelling of data from gait analysis
Time Frame
Baseline and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Devita, MSc, PhD
Organizational Affiliation
The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum Greenville, U.S.A.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marius Henriksen, PhD
Organizational Affiliation
The Parker Institute, Frederiksberg University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
The Parker Institute, Frederiksberg University Hospital
City
Copenhagen
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30273922
Citation
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.
Results Reference
derived

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Strengthening Exercise and Quadriceps Force During Walking

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