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Platform Exercise Training

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Body Vibration Training
Exercise without vibration
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthritis, whole body vibration, mobility, rehabilitation

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age 45-60
  • female
  • history of knee injury or surgery (except replacement surgery) or body mass index (BMI) greater than or equal to 25.

Exclusion Criteria:

  • diagnosis of knee osteoarthritis
  • inflammatory arthritis such as rheumatoid or psoriatic arthritis
  • knee replacement
  • metallic implant or stent placement surgery or any implanted devices
  • surgery or lower limb injury in the last 6 months that affects walking ability
  • lower limb amputation (other than single ray)
  • unable to walk without an assistive device
  • wounds that contraindicate weight-bearing exercise
  • acute infection or inflammation that contraindicates exercise
  • acute disk related problems (new lower back pain in the last 3 months or severe enough to affect walking)
  • osteonecrosis
  • currently pregnant or planning to become pregnant
  • kidney, bladder or gallstones that have not been passed
  • retinal detachment
  • ever experienced deep vein thrombosis
  • type 1 diabetes mellitus (insulin dependent)
  • history of myocardial infarction or stroke in the last year
  • medical conditions that affect walking ability or ability to take part in the study or exercise such as; Alzheimer's disease, multiple sclerosis, Parkinson's disease, severe cardiovascular disease, congestive heart failure, severe emphysema, severe asthma, severe dysrhythmias or pacemaker
  • Any type of implanted pump (e.g. Morphine, baclofen) or catheter (e.g. In kidney, brain or spine)
  • neuropathy (by Semmes-Weinstein Monofilament)
  • uncontrolled epilepsy
  • active cancer (< 5 years since remission) or other illness expected to be terminal within 1 year
  • concurrent participation in another research study
  • Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
  • frequent knee pain on most of the last 30 days

Sites / Locations

  • The University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Whole Body Vibration Training

Exercise without vibration

Arm Description

The subjects will participate in a 12-week whole body vibration exercise program with 2 sessions (1/2 hour) per week.

The subjects will participate in a 12-week exercise program with 2 sessions (1/2 hour) per week.

Outcomes

Primary Outcome Measures

Isokinetic quadriceps strength

Secondary Outcome Measures

Vibration Perception Threshold
Leg press muscle power
Timed Stair Climb

Full Information

First Posted
November 2, 2010
Last Updated
April 7, 2011
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01239823
Brief Title
Platform Exercise Training
Official Title
Platform Exercise Training for Women at Risk for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthritis, whole body vibration, mobility, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Vibration Training
Arm Type
Experimental
Arm Description
The subjects will participate in a 12-week whole body vibration exercise program with 2 sessions (1/2 hour) per week.
Arm Title
Exercise without vibration
Arm Type
Experimental
Arm Description
The subjects will participate in a 12-week exercise program with 2 sessions (1/2 hour) per week.
Intervention Type
Other
Intervention Name(s)
Whole Body Vibration Training
Intervention Description
The subjects will participate in a 12-week exercise program with two sessions (1/2 hour) per week.
Intervention Type
Other
Intervention Name(s)
Exercise without vibration
Intervention Description
Participants will complete the same exercises without vibration twice a week for 12 weeks (1/2 hour sessions).
Primary Outcome Measure Information:
Title
Isokinetic quadriceps strength
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Vibration Perception Threshold
Time Frame
Change from baseline to 12 weeks
Title
Leg press muscle power
Time Frame
Change from baseline to 12 weeks
Title
Timed Stair Climb
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 45-60 female history of knee injury or surgery (except replacement surgery) or body mass index (BMI) greater than or equal to 25. Exclusion Criteria: diagnosis of knee osteoarthritis inflammatory arthritis such as rheumatoid or psoriatic arthritis knee replacement metallic implant or stent placement surgery or any implanted devices surgery or lower limb injury in the last 6 months that affects walking ability lower limb amputation (other than single ray) unable to walk without an assistive device wounds that contraindicate weight-bearing exercise acute infection or inflammation that contraindicates exercise acute disk related problems (new lower back pain in the last 3 months or severe enough to affect walking) osteonecrosis currently pregnant or planning to become pregnant kidney, bladder or gallstones that have not been passed retinal detachment ever experienced deep vein thrombosis type 1 diabetes mellitus (insulin dependent) history of myocardial infarction or stroke in the last year medical conditions that affect walking ability or ability to take part in the study or exercise such as; Alzheimer's disease, multiple sclerosis, Parkinson's disease, severe cardiovascular disease, congestive heart failure, severe emphysema, severe asthma, severe dysrhythmias or pacemaker Any type of implanted pump (e.g. Morphine, baclofen) or catheter (e.g. In kidney, brain or spine) neuropathy (by Semmes-Weinstein Monofilament) uncontrolled epilepsy active cancer (< 5 years since remission) or other illness expected to be terminal within 1 year concurrent participation in another research study Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions) frequent knee pain on most of the last 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil A Segal, MD, MS
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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Platform Exercise Training

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