NCT01239823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 11, 2011

Status Verified

April 1, 2011

Enrollment Period

4 months

First QC Date

November 2, 2010

Last Update Submit

April 7, 2011

Conditions

Keywords

osteoarthritiswhole body vibrationmobilityrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Isokinetic quadriceps strength

    Change from baseline to 12 weeks

Secondary Outcomes (3)

  • Vibration Perception Threshold

    Change from baseline to 12 weeks

  • Leg press muscle power

    Change from baseline to 12 weeks

  • Timed Stair Climb

    Change from baseline to 12 weeks

Study Arms (2)

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.

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.

Other: Exercise without vibration

Interventions

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

Whole Body Vibration Training

Participants will complete the same exercises without vibration twice a week for 12 weeks (1/2 hour sessions).

Exercise without vibration

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (27)

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    BACKGROUND
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    PMID: 10625033BACKGROUND
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    PMID: 9429738BACKGROUND
  • Guccione AA. Arthritis and the process of disablement. Phys Ther. 1994 May;74(5):408-14. doi: 10.1093/ptj/74.5.408.

    PMID: 8171102BACKGROUND
  • Kramer 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.

    PMID: 6223644BACKGROUND
  • Hurley 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.

    PMID: 10356418BACKGROUND
  • McGibbon 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.

    PMID: 12687518BACKGROUND
  • Felson DT. Epidemiology of hip and knee osteoarthritis. Epidemiol Rev. 1988;10:1-28. doi: 10.1093/oxfordjournals.epirev.a036019.

    PMID: 3066625BACKGROUND
  • Centers 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.

    PMID: 12437034BACKGROUND
  • Davis MA. Epidemiology of osteoarthritis. Clin Geriatr Med. 1988 May;4(2):241-55.

    PMID: 3288318BACKGROUND
  • Andersen 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.

    PMID: 10591238BACKGROUND
  • Bautmans 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.

    PMID: 16372905BACKGROUND
  • Roelants 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.

    PMID: 15161453BACKGROUND
  • Kawanabe 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.

    PMID: 17392595BACKGROUND
  • Bruyere 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.

    PMID: 15706558BACKGROUND
  • Bogaerts A, Verschueren S, Delecluse C, Claessens AL, Boonen S. Effects of whole body vibration training on postural control in older individuals: a 1 year randomized controlled trial. Gait Posture. 2007 Jul;26(2):309-16. doi: 10.1016/j.gaitpost.2006.09.078. Epub 2006 Oct 30.

    PMID: 17074485BACKGROUND
  • van den Tillaar R. Will whole-body vibration training help increase the range of motion of the hamstrings? J Strength Cond Res. 2006 Feb;20(1):192-6. doi: 10.1519/R-17064.1.

    PMID: 16503680BACKGROUND
  • Trans T, Aaboe J, Henriksen M, Christensen R, Bliddal H, Lund H. Effect of whole body vibration exercise on muscle strength and proprioception in females with knee osteoarthritis. Knee. 2009 Aug;16(4):256-61. doi: 10.1016/j.knee.2008.11.014. Epub 2009 Jan 15.

    PMID: 19147365BACKGROUND
  • Segal NA, Glass NA, Torner J, Yang M, Felson DT, Sharma L, Nevitt M, Lewis CE. Quadriceps weakness predicts risk for knee joint space narrowing in women in the MOST cohort. Osteoarthritis Cartilage. 2010 Jun;18(6):769-75. doi: 10.1016/j.joca.2010.02.002. Epub 2010 Feb 11.

    PMID: 20188686BACKGROUND
  • Segal NA, Torner JC, Felson D, Niu J, Sharma L, Lewis CE, Nevitt M. Effect of thigh strength on incident radiographic and symptomatic knee osteoarthritis in a longitudinal cohort. Arthritis Rheum. 2009 Sep 15;61(9):1210-7. doi: 10.1002/art.24541.

    PMID: 19714608BACKGROUND
  • Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham Osteoarthritis Study. Semin Arthritis Rheum. 1990 Dec;20(3 Suppl 1):42-50. doi: 10.1016/0049-0172(90)90046-i.

    PMID: 2287948BACKGROUND
  • Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.

    PMID: 16385518BACKGROUND
  • Fried LP, Bandeen-Roche K, Chaves PH, Johnson BA. Preclinical mobility disability predicts incident mobility disability in older women. J Gerontol A Biol Sci Med Sci. 2000 Jan;55(1):M43-52. doi: 10.1093/gerona/55.1.m43.

    PMID: 10719772BACKGROUND
  • Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.

    PMID: 7838189BACKGROUND
  • Ling SM, Fried LP, Garrett ES, Fan MY, Rantanen T, Bathon JM. Knee osteoarthritis compromises early mobility function: The Women's Health and Aging Study II. J Rheumatol. 2003 Jan;30(1):114-20.

    PMID: 12508399BACKGROUND
  • Davis MA, Ettinger WH, Neuhaus JM, Mallon KP. Knee osteoarthritis and physical functioning: evidence from the NHANES I Epidemiologic Followup Study. J Rheumatol. 1991 Apr;18(4):591-8.

    PMID: 2066950BACKGROUND
  • Guccione AA, Felson DT, Anderson JJ. Defining arthritis and measuring functional status in elders: methodological issues in the study of disease and physical disability. Am J Public Health. 1990 Aug;80(8):945-9. doi: 10.2105/ajph.80.8.945.

    PMID: 2368855BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

ExerciseVibration

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMechanical PhenomenaPhysical Phenomena

Study Officials

  • Neil A Segal, MD, MS

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 11, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 11, 2011

Record last verified: 2011-04

Locations