Clinical trial NCT02098096: Negative Work Exercise for the Treatment of Knee Arthritis
Official title: Development of a Negative Work Exercise Regimen as an Intervention for Posttraumatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Arthritis
Keywords: knee
arthritis
Veterans
strength
exercise
muscle
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2014-03-27
Enrollment: 54
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum Voluntary Contraction (MVC; ft-lbs)
timeFrame: 12 weeks
measure: Muscle thickness (cm)
timeFrame: 12 weeks
Secondary outcomes:
measure: Step Up/Over Test (movement time (s); kinetics (force indices)
timeFrame: 12 weeks
measure: Physical Performance Test (PPT-7)
timeFrame: 12 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS; English version LK1.0)
timeFrame: 12 weeks
measure: Visual Analog Scale for Pain (VAS; 0-10)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center
name: Michael Harris-Love, DSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.