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

Primary Purpose

Osteoarthritis, Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative Work
Stretching
Sponsored by
Washington D.C. Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring knee, arthritis, Veterans, strength, exercise, muscle

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington DC VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Negative Work

Stretching

Arm Description

Negative work exercise via isokinetic knee extension/flexion will be performed twice per week for 12 weeks.

A home exercise program consisting of stretches for the major lower extremity muscles groups will be performed twice per week for 12 weeks.

Outcomes

Primary Outcome Measures

Maximum Voluntary Contraction (MVC; ft-lbs)
Isokinetic assessment of MVC for the knee extensors and flexors.
Muscle thickness (cm)
Diagnostic ultrasound assessment of the rectus femoris

Secondary Outcome Measures

Step Up/Over Test (movement time (s); kinetics (force indices)
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)
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)
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)
VAS will be assessed using a pressure algometer at the mid-thigh before and after negative work exercise.

Full Information

First Posted
March 19, 2014
Last Updated
September 18, 2018
Sponsor
Washington D.C. Veterans Affairs Medical Center
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT02098096
Brief Title
Negative Work Exercise for the Treatment of Knee Arthritis
Acronym
PTOA-ECC
Official Title
Development of a Negative Work Exercise Regimen as an Intervention for Posttraumatic Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington D.C. Veterans Affairs Medical Center
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Arthritis
Keywords
knee, arthritis, Veterans, strength, exercise, muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Work
Arm Type
Experimental
Arm Description
Negative work exercise via isokinetic knee extension/flexion will be performed twice per week for 12 weeks.
Arm Title
Stretching
Arm Type
Placebo Comparator
Arm Description
A home exercise program consisting of stretches for the major lower extremity muscles groups will be performed twice per week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Negative Work
Other Intervention Name(s)
Eccentric exercise
Intervention Description
Exercise will be performed twice per week for 12 weeks and exercise intensity will be progressed in three phases. These phases are: Familiarization Acclimatization 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.
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
Home exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period.
Primary Outcome Measure Information:
Title
Maximum Voluntary Contraction (MVC; ft-lbs)
Description
Isokinetic assessment of MVC for the knee extensors and flexors.
Time Frame
12 weeks
Title
Muscle thickness (cm)
Description
Diagnostic ultrasound assessment of the rectus femoris
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Step Up/Over Test (movement time (s); kinetics (force indices)
Description
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.
Time Frame
12 weeks
Title
Physical Performance Test (PPT-7)
Description
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.
Time Frame
12 weeks
Title
Knee injury and Osteoarthritis Outcome Score (KOOS; English version LK1.0)
Description
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.
Time Frame
12 weeks
Title
Visual Analog Scale for Pain (VAS; 0-10)
Description
VAS will be assessed using a pressure algometer at the mid-thigh before and after negative work exercise.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harris-Love, DSc
Organizational Affiliation
Washington DC VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15934111
Citation
Harris-Love MO. Safety and efficacy of submaximal eccentric strength training for a subject with polymyositis. Arthritis Rheum. 2005 Jun 15;53(3):471-4. doi: 10.1002/art.21185. No abstract available.
Results Reference
background
PubMed Identifier
26217665
Citation
Hernandez HJ, McIntosh V, Leland A, Harris-Love MO. Progressive Resistance Exercise with Eccentric Loading for the Management of Knee Osteoarthritis. Front Med (Lausanne). 2015 Jul 9;2:45. doi: 10.3389/fmed.2015.00045. eCollection 2015.
Results Reference
background

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Negative Work Exercise for the Treatment of Knee Arthritis

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