Knee Osteoarthritis Clinical Trial
Official title:
Platform Exercise Training for Women at Risk for Knee Osteoarthritis
The purpose of this randomized, controlled trial is to determine whether a vibration platform exercise program will be more effective than a standard platform exercise program in improving quadriceps strength in women age 45-60 who have risk factors for knee osteoarthritis. Each platform exercise program will be conducted 2 times a week for 12 weeks. The sessions will consist of a series of exercises on a Wave Pro-elite vibration platform (with 1-3 minute rests between sets) and stretches with the platform vibration either turned on (intervention group) or off (control group.) Quadriceps strength (primary outcome), leg press power, and vibration sense will be assessed at baseline and 12 weeks, and changed scores will be compared between groups.
Osteoarthritis (OA) is the most common disabling disease in older adults,(1) affecting over
25 million Americans, resulting in significantly impaired function and mobility(2) and a
societal economic burden.(3) The knee is the weight-bearing joint most commonly
affected,(10) and the prevalence of symptomatic knee OA is between 9% and 21% among those 65
years and older.(2, 11, 21) Loss of knee range of motion can lead to significant difficulty
in bathing, lower body dressing, stair mobility, and walking.
Impaired mobility due to knee OA will have an increasingly significant societal impact, with
67 million adults projected to have arthritis by 2030, and 25 million with
arthritis-attributable activity limitations.(22) Women are at greater risk for knee OA
compared with men. Knee OA leads to chronic disability,(23-25) functional limitations,(26)
and dependence.(27) Patients with knee OA frequently are limited in their activities by
joint stiffness or buckling, decreased range of motion, muscle weakness, poor balance,
impaired proprioception, reduced vibration sense, and/or pain. Currently, there are limited
options available for patients for improving the outcome of knee OA once they have it. At
this time, patients may use analgesics for pain with total knee replacement as the last
option. However, we recently found that greater quadriceps strength protected against the
development of incident symptomatic knee OA and progression of knee OA in women.(19-20)
Thus, strengthening the quadriceps muscle may prevent worsening of the knee joint. Though
before studying whether strengthening is effective in reducing risk for knee OA, it is
necessary to first determine an effective and tolerated means of exercise.
Vibration platform exercise may provide the benefits of strength training without adding
potentially harmful loads to the knee joint. In one study of nursing home residents with
limited functional capacity, balance and mobility improved over a 6-week whole body
vibration exercise program. (12) In another study that compared whole body vibration (WBV)
to resistance training in older women, greater improvement in knee extensor strength and
speed of movement was found with WBV exercise.(13) Additionally, after a 2-month exercise
program with older adults between the ages of 59 to 86, walking speed, step length, and the
maximum standing time on one leg significantly improved with WBV exercise.(14) WBV exercise
was safe and well tolerated in the elderly.(14, 15, 16) There have also been indications
that WBV may improve flexibility. While a study testing range of motion (ROM) found that
both the WBV and the control groups had significant increases in hamstring flexibility, only
the WBV group showed a significantly larger increase (30%) in ROM than did the control group
(14%).(17) There have also been indications WBV may improve proprioception (joint position
sense) in women with knee osteoarthritis. One study which compared control versus exercise
on a vibration platform and a balance board vibration platform found improvements in muscle
strength and proprioception, respectively.(18) Thus, these studies suggest a beneficial
effect of WBV exercise in addition to muscle strengthening, balance, and walking exercises
in improving the walking ability in the elderly.
Exercises conducted on a vibrating platform will induce a muscle reflex, increasing muscle
fiber activation at a higher level compared to performing the exercises on a non-vibrating
platform. We have selected the frequency and duration of this program based on 1) frequency
used in previous studies and recommended by the manufacturer and 2) duration of 12 weeks
based on previous data which found the most gain in knee extensor strength and speed of the
movement occurred at week 12 of a 24-week program. (13)
Vibration exercise may be a better option than strength training alone, if the exercises can
be completed in less time and with similar strength gains as resistance training, but
without the additional loads contributing to the stress on patients' joints.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04651673 -
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
|
||
Completed |
NCT05677399 -
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
|
N/A | |
Active, not recruiting |
NCT04043819 -
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT06000410 -
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
|
Phase 3 | |
Completed |
NCT05014542 -
Needling Techniques for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05892133 -
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05528965 -
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Active, not recruiting |
NCT02003976 -
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
|
N/A | |
Active, not recruiting |
NCT04017533 -
Stability of Uncemented Medially Stabilized TKA
|
N/A | |
Completed |
NCT04779164 -
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT04006314 -
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05423587 -
Genicular Artery Embolisation for Knee Osteoarthritis II
|
N/A | |
Enrolling by invitation |
NCT04145401 -
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
|
||
Active, not recruiting |
NCT03781843 -
Effects of Genicular Nerve Block in Knee Osteoarthritis
|
N/A | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05324163 -
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
|
Phase 3 | |
Completed |
NCT05529914 -
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05693493 -
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
|
N/A | |
Not yet recruiting |
NCT05510648 -
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
|
N/A |