Platform Exercise Training

April 7, 2011 updated by: University of Iowa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Whole Body Vibration Training
The subjects will participate in a 12-week whole body vibration exercise program with 2 sessions (1/2 hour) per week.
Other: Whole Body Vibration Training
The subjects will participate in a 12-week exercise program with two sessions (1/2 hour) per week.
EXPERIMENTAL: Exercise without vibration
The subjects will participate in a 12-week exercise program with 2 sessions (1/2 hour) per week.
Other: Exercise without vibration
Participants will complete the same exercises without vibration twice a week for 12 weeks (1/2 hour sessions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Isokinetic quadriceps strength
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Vibration Perception Threshold
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks
Leg press muscle power
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks
Timed Stair Climb
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (ESTIMATE)

November 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2009120009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Whole Body Vibration Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe