Negative Work Exercise for the Treatment of Knee Arthritis (PTOA-ECC)
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|ClinicalTrials.gov Identifier: NCT02098096|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2014
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Arthritis||Other: Negative Work Other: Stretching||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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:
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.
Home exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period.
- 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
- 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.
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
|United States, District of Columbia|
|Washington DC VA Medical Center|
|Washington, District of Columbia, United States, 20422|
|Principal Investigator:||Michael Harris-Love, DSc||Washington DC VA Medical Center|