Knee OsteoarthritisNCT01239823
Platform Exercise Training
A study testing Whole Body Vibration Training and Exercise without vibration in people with Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Whole Body Vibration Training and Exercise without vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 45-60
- female
- history of knee injury or surgery (except replacement surgery) or body mass index (BMI) greater than or equal to 25.
Who cannot join
- 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)
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Whole Body Vibration Training, Exercise without vibration
- Keywords
- osteoarthritis, whole body vibration, mobility, rehabilitation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Vibration TrainingOther
The subjects will participate in a 12-week exercise program with two sessions (1/2 hour) per week.
Exercise without vibrationOther
Participants will complete the same exercises without vibration twice a week for 12 weeks (1/2 hour sessions).
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration Training | Experimental | The subjects will participate in a 12-week whole body vibration exercise program with 2 sessions (1/2 hour) per week. Receives: Other: Whole Body Vibration Training |
| Exercise without vibration | Experimental | The subjects will participate in a 12-week exercise program with 2 sessions (1/2 hour) per week. Receives: Other: Exercise without vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic quadriceps strength
Measured: Change from baseline to 12 weeks
Secondary outcomes (3)
Vibration Perception Threshold
Measured: Change from baseline to 12 weeks
Leg press muscle power
Measured: Change from baseline to 12 weeks
Timed Stair Climb
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Investigators
- Neil A Segal, MD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239823
- Sponsor's protocol ID
- N2009120009
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 2010
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
The American Geriatrics Society. Research and Geriatric Medicine Position Statement. http://www.americangeriatrics.org/products/positionpapers/research.shtml ed. New York: AGS Public Policy Committee; 1999.
Nevitt MC, Lane N. Body weight and osteoarthritis. Am J Med. 1999 Dec;107(6):632-3. doi: 10.1016/s0002-9343(99)00297-1. No abstract available.
PubMed 10625033March LM, Bachmeier CJ. Economics of osteoarthritis: a global perspective. Baillieres Clin Rheumatol. 1997 Nov;11(4):817-34. doi: 10.1016/s0950-3579(97)80011-8.
PubMed 9429738Guccione AA. Arthritis and the process of disablement. Phys Ther. 1994 May;74(5):408-14. doi: 10.1093/ptj/74.5.408.
PubMed 8171102Kramer JS, Yelin EH, Epstein WV. Social and economic impacts of four musculoskeletal conditions. A study using national community-based data. Arthritis Rheum. 1983 Jul;26(7):901-7. doi: 10.1002/art.1780260712.
PubMed 6223644Hurley MV. The role of muscle weakness in the pathogenesis of osteoarthritis. Rheum Dis Clin North Am. 1999 May;25(2):283-98, vi. doi: 10.1016/s0889-857x(05)70068-5.
PubMed 10356418McGibbon CA, Krebs DE, Scarborough DM. Rehabilitation effects on compensatory gait mechanics in people with arthritis and strength impairment. Arthritis Rheum. 2003 Apr 15;49(2):248-54. doi: 10.1002/art.11005. No abstract available.
PubMed 12687518Felson DT. Epidemiology of hip and knee osteoarthritis. Epidemiol Rev. 1988;10:1-28. doi: 10.1093/oxfordjournals.epirev.a036019.
PubMed 3066625Centers for Disease Control and Prevention (CDC). Prevalence of self-reported arthritis or chronic joint symptoms among adults--United States, 2001. MMWR Morb Mortal Wkly Rep. 2002 Oct 25;51(42):948-50.
PubMed 12437034Davis MA. Epidemiology of osteoarthritis. Clin Geriatr Med. 1988 May;4(2):241-55.
PubMed 3288318Andersen RE, Crespo CJ, Ling SM, Bathon JM, Bartlett SJ. Prevalence of significant knee pain among older Americans: results from the Third National Health and Nutrition Examination Survey. J Am Geriatr Soc. 1999 Dec;47(12):1435-8. doi: 10.1111/j.1532-5415.1999.tb01563.x.
PubMed 10591238Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.
PubMed 16372905Roelants M, Delecluse C, Verschueren SM. Whole-body-vibration training increases knee-extension strength and speed of movement in older women. J Am Geriatr Soc. 2004 Jun;52(6):901-8. doi: 10.1111/j.1532-5415.2004.52256.x.
PubMed 15161453Kawanabe K, Kawashima A, Sashimoto I, Takeda T, Sato Y, Iwamoto J. Effect of whole-body vibration exercise and muscle strengthening, balance, and walking exercises on walking ability in the elderly. Keio J Med. 2007 Mar;56(1):28-33. doi: 10.2302/kjm.56.28.
PubMed 17392595Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
PubMed 15706558
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platform Exercise Training for Women at Risk for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01239823
- Acronym / sponsor ID
- N2009120009
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, whole body vibration, mobility, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration Training | Experimental | Other: Whole Body Vibration TrainingThe subjects will participate in a 12-week whole body vibration exercise program with 2 sessions (1/2 hour) per week. |
| Exercise without vibration | Experimental | Other: Exercise without vibrationThe subjects will participate in a 12-week exercise program with 2 sessions (1/2 hour) per week. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 45-60
- female
- history of knee injury or surgery (except replacement surgery) or body mass index (BMI) greater than or equal to 25.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body Vibration TrainingThe subjects will participate in a 12-week exercise program with two sessions (1/2 hour) per week. | Other | Whole Body Vibration Training |
| Exercise without vibrationParticipants will complete the same exercises without vibration twice a week for 12 weeks (1/2 hour sessions). | Other | Exercise without vibration |
Primary outcome
Isokinetic quadriceps strength
Time frame: Change from baseline to 12 weeks
3 secondary outcomes
Vibration Perception Threshold
Time frame: Change from baseline to 12 weeks
Leg press muscle power
Time frame: Change from baseline to 12 weeks
Timed Stair Climb
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
- BackgroundThe American Geriatrics Society. Research and Geriatric Medicine Position Statement. http://www.americangeriatrics.org/products/positionpapers/research.shtml ed. New York: AGS Public Policy Committee; 1999.
- Background: PubMed 10625033Nevitt MC, Lane N. Body weight and osteoarthritis. Am J Med. 1999 Dec;107(6):632-3. doi: 10.1016/s0002-9343(99)00297-1. No abstract available.
- Background: PubMed 9429738March LM, Bachmeier CJ. Economics of osteoarthritis: a global perspective. Baillieres Clin Rheumatol. 1997 Nov;11(4):817-34. doi: 10.1016/s0950-3579(97)80011-8.
- Background: PubMed 8171102Guccione AA. Arthritis and the process of disablement. Phys Ther. 1994 May;74(5):408-14. doi: 10.1093/ptj/74.5.408.
- Background: PubMed 6223644Kramer JS, Yelin EH, Epstein WV. Social and economic impacts of four musculoskeletal conditions. A study using national community-based data. Arthritis Rheum. 1983 Jul;26(7):901-7. doi: 10.1002/art.1780260712.
- Background: PubMed 10356418Hurley MV. The role of muscle weakness in the pathogenesis of osteoarthritis. Rheum Dis Clin North Am. 1999 May;25(2):283-98, vi. doi: 10.1016/s0889-857x(05)70068-5.
- Background: PubMed 12687518McGibbon CA, Krebs DE, Scarborough DM. Rehabilitation effects on compensatory gait mechanics in people with arthritis and strength impairment. Arthritis Rheum. 2003 Apr 15;49(2):248-54. doi: 10.1002/art.11005. No abstract available.
- Background: PubMed 3066625Felson DT. Epidemiology of hip and knee osteoarthritis. Epidemiol Rev. 1988;10:1-28. doi: 10.1093/oxfordjournals.epirev.a036019.
- Background: PubMed 12437034Centers for Disease Control and Prevention (CDC). Prevalence of self-reported arthritis or chronic joint symptoms among adults--United States, 2001. MMWR Morb Mortal Wkly Rep. 2002 Oct 25;51(42):948-50.
- Background: PubMed 3288318Davis MA. Epidemiology of osteoarthritis. Clin Geriatr Med. 1988 May;4(2):241-55.
- Background: PubMed 10591238Andersen RE, Crespo CJ, Ling SM, Bathon JM, Bartlett SJ. Prevalence of significant knee pain among older Americans: results from the Third National Health and Nutrition Examination Survey. J Am Geriatr Soc. 1999 Dec;47(12):1435-8. doi: 10.1111/j.1532-5415.1999.tb01563.x.
- Background: PubMed 16372905Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil A Segal, MD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration Training and Exercise without vibration in people with Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic quadriceps strength (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239823, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2011.