Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Negative Work Exercise for the Treatment of Knee Arthritis (PTOA-ECC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02098096
Recruitment Status : Unknown
Verified September 2018 by Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : March 27, 2014
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE March 19, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date September 20, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Maximum Voluntary Contraction (MVC; ft-lbs) [ Time Frame: 12 weeks ]
    Isokinetic assessment of MVC for the knee extensors and flexors.
  • Muscle thickness (cm) [ Time Frame: 12 weeks ]
    Diagnostic ultrasound assessment of the rectus femoris
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Step Up/Over Test (movement time (s); kinetics (force indices) [ Time Frame: 12 weeks ]
    The Step Up/Over Test involves stepping over an 8'' block with the use of a force plate. We will assess concentric force upon ascent, and eccentric force upon descent; the symmetry of these forces will be expressed as an index.
  • Physical Performance Test (PPT-7) [ Time Frame: 12 weeks ]
    The PPT-7 is a performance-based assessment of function validated for use in older adults. Participant scores will be compared to reference, age-matched, data.
  • Knee injury and Osteoarthritis Outcome Score (KOOS; English version LK1.0) [ Time Frame: 12 weeks ]
    Knee OA-specific questionnaire concerning mobility and health-related quality of life changes over time. Participant scores will be compared to a normative comparison group, and the published minimal detectable change scores as validated for a knee OA reference group.
  • Visual Analog Scale for Pain (VAS; 0-10) [ Time Frame: 12 weeks ]
    VAS will be assessed using a pressure algometer at the mid-thigh before and after negative work exercise.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Negative Work Exercise for the Treatment of Knee Arthritis
Official Title  ICMJE Development of a Negative Work Exercise Regimen as an Intervention for Posttraumatic Osteoarthritis of the Knee
Brief Summary The purpose of this study is to develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). "Negative work" is the force produced by muscles as they lengthen, and regularly occurs with common activities such as lowering an object from a shelf or walking down stairs. In this study, the investigators are examining the effectiveness of negative work exercise over a 12-week period in older, male, Veterans.
Detailed Description

Purpose: To develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). Given that the medical management of chronic PTOA is similar to idiopathic OA, the investigators propose a randomized, clinical trial to pilot negative work exercise in Veterans with knee OA as a proof-of-concept study for a subsequent investigation for people with PTOA.

Research Setting: DC VAMC, Physical Medicine & Rehabilitation Laboratory

Participants: Men between the ages of 50 and 70 years with a history of bilateral knee osteoarthritis will be consecutively recruited from the DC VAMC Rheumatology Service, Geriatrics Service, and Primary Care Medical Service.

Implications/Significance: The use of negative work exercise to enhance the force attenuation properties of muscle is an innovative approach to the treatment of OA and PTOA, and represents a significant departure from previous rehabilitation studies concerning arthritis. Use of a negative work paradigm may prove to be beneficial for older Veterans with OA and active military personnel with PTOA since similar muscle mechanics are involved in the energy absorption at the knee joint during gait. Despite the functional importance of lengthening muscle actions in protecting weight-bearing joints affected by arthritis, the authors are not aware of a study that involves the sole use of a negative work intervention for OA or PTOA. Addressing the aims of this proposal would lay the ground work needed to justify larger clinical trials featuring the negative work paradigm for soldiers with PTOA.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Arthritis
Intervention  ICMJE
  • Other: Negative Work

    Exercise will be performed twice per week for 12 weeks and exercise intensity will be progressed in three phases. These phases are:

    1. Familiarization
    2. Acclimatization
    3. Progression

    Exercise volume will be 3 sets of 10 repetitions (progressing to 4 sets at Week 6) for the knee flexors and extensors.

    All exercise will be supervised by a physical therapist and performed on a Biodex isokinetic dynamometer.

    Other Name: Eccentric exercise
  • Other: Stretching
    Home exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period.
Study Arms  ICMJE
  • Experimental: Negative Work
    Negative work exercise via isokinetic knee extension/flexion will be performed twice per week for 12 weeks.
    Intervention: Other: Negative Work
  • Placebo Comparator: Stretching
    A home exercise program consisting of stretches for the major lower extremity muscles groups will be performed twice per week for 12 weeks.
    Intervention: Other: Stretching
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 24, 2014)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult men 50 y.o. 70 years old will be recruited for this proposed study.
  • Participant inclusion criteria includes having bilateral knee OA (Kellgren-Lawrence Grade 2 or 3) and sedentary (e.g., have not engaged in 3 exercise sessions per week for 3 consecutive months).
  • Gait aides and orthoses will not preclude participation in this study.

Exclusion Criteria:

  • Exclusion criteria include uncontrolled cardiovascular disease, non-ambulatory status, neurogenic weakness, knee extensor and flexor manual muscle test < 3 out of 5, lower extremity amputation, and current participation in a supervised exercise program.
  • In addition, major surgical procedures within the last six months, unstable joints, endocrine or metabolic disorders that result in excessive fatigue or muscle weakness, or use of medications that may impair exercise tolerance would also preclude participation in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02098096
Other Study ID Numbers  ICMJE MIRB01625
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center
Study Sponsor  ICMJE Washington D.C. Veterans Affairs Medical Center
Collaborators  ICMJE US Department of Veterans Affairs
Investigators  ICMJE
Principal Investigator: Michael Harris-Love, DSc Washington DC VA Medical Center
PRS Account Washington D.C. Veterans Affairs Medical Center
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP