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

September 18, 2018 updated by: Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center

Development of a Negative Work Exercise Regimen as an Intervention for Posttraumatic Osteoarthritis of the Knee

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington DC VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Voluntary Contraction (MVC; ft-lbs)
Time Frame: 12 weeks
Isokinetic assessment of MVC for the knee extensors and flexors.
12 weeks
Muscle thickness (cm)
Time Frame: 12 weeks
Diagnostic ultrasound assessment of the rectus femoris
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington D.C. Veterans Affairs Medical Center

Collaborators

US Department of Veterans Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (ESTIMATE)

March 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRB01625

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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