Platform Exercise Training

Knee Osteoarthritis Clinical Trial

Official title:

Platform Exercise Training for Women at Risk for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239823
• Other study ID #: N2009120009
• Status: Completed
• Phase: N/A
• First received: November 2, 2010
• Last updated: April 7, 2011
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	The University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (27)

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. — View Citation

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. — View Citation

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. Epub 2006 Oct 30. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Davis MA. Epidemiology of osteoarthritis. Clin Geriatr Med. 1988 May;4(2):241-55. Review. — View Citation

Felson DT. Epidemiology of hip and knee osteoarthritis. Epidemiol Rev. 1988;10:1-28. Review. — View Citation

Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham Osteoarthritis Study. Semin Arthritis Rheum. 1990 Dec;20(3 Suppl 1):42-50. — View Citation

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. — View Citation

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. — View Citation

Guccione AA. Arthritis and the process of disablement. Phys Ther. 1994 May;74(5):408-14. — View Citation

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. — View Citation

Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. — View Citation

Hurley MV. The role of muscle weakness in the pathogenesis of osteoarthritis. Rheum Dis Clin North Am. 1999 May;25(2):283-98, vi. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

March LM, Bachmeier CJ. Economics of osteoarthritis: a global perspective. Baillieres Clin Rheumatol. 1997 Nov;11(4):817-34. Review. — View Citation

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. — View Citation

Nevitt MC, Lane N. Body weight and osteoarthritis. Am J Med. 1999 Dec;107(6):632-3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isokinetic quadriceps strength		Change from baseline to 12 weeks	No
Secondary	Vibration Perception Threshold		Change from baseline to 12 weeks	No
Secondary	Leg press muscle power		Change from baseline to 12 weeks	No
Secondary	Timed Stair Climb		Change from baseline to 12 weeks	No