Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthritis Other: Negative Work Other: Stretching Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Negative Work Exercise Regimen as an Intervention for Posttraumatic Osteoarthritis of the Knee
Study Start Date : March 2014
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Negative Work
Negative work exercise via isokinetic knee extension/flexion will be performed twice per week for 12 weeks.
 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
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.
 Other: Stretching
Home exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maximum Voluntary Contraction (MVC; ft-lbs) [ Time Frame: 12 weeks ]
    Isokinetic assessment of MVC for the knee extensors and flexors.

  2. Muscle thickness (cm) [ Time Frame: 12 weeks ]
    Diagnostic ultrasound assessment of the rectus femoris


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098096


Locations
Layout table for location information
United States, District of Columbia
Washington DC VA Medical Center
Washington, District of Columbia, United States, 20422
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
US Department of Veterans Affairs
Investigators
Layout table for investigator information
Principal Investigator: Michael Harris-Love, DSc Washington DC VA Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Michael Harris-Love, Primary Investigator, Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02098096    
Other Study ID Numbers: MIRB01625
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Keywords provided by Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center:
knee
arthritis
Veterans
 strength
exercise
muscle
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases