Effects of a Fall Preventive Exercise Program on Intrinsic Fall Risk Factors in Healthy Older Adults.

Fall Prevention Clinical Trial

Official title:

Effects of a Fall Preventive Exercise Program on Intrinsic Fall Risk Factors in Healthy Older Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906034
• Other study ID #: BFU-2.104
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: March 19, 2017
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2017
• Source: University of Potsdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested.

Methods/Design Healthy old people (N = 66) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale - International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with each training session lasting 30 min (without warm-up and cool-down). One intervention group will complete a supervised training program (2x supervised training per week / 1x home training per week), while the other intervention group will complete a training after the same protocol that is home-based (3x home training per week) and controlled by phone calls every two weeks. Post-tests will be conducted right after the intervention period. Additionally, detraining effects will be measured 12 weeks after program cessation. The control group / waiting group will not participate in any specific intervention during the experimental period, but will receive the extensive supervised program after the experimental period.

Discussion It is expected that particularly the supervised combination of balance and strength / power training will improve performance in variables of balance, strength / power, body composition, cognitive function, psychosocial well-being, and falls self-efficacy of older adults. In addition, information regarding fall risk assessment, detraining effects, and supervision of training will be provided. Further, training-induced health-relevant changes, such as improved performance in activities of daily living, cognitive function, and quality of life, as well as a reduced risk for falls may help to lower costs in the health care system. Finally, practitioners, therapists, and instructors will be provided with a scientifically evaluated, feasible, safe, and easy-to-administer exercise program for fall prevention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• 65-80 years old

• must be able to accomplish the tests and the training

• must be able to walk independently

Exclusion Criteria:

• neurological diseases: Alzheimer´s disease, Multiple Sclerosis, Parkinson etc.

• cardiovascular diseases: coronary heart disease, cardiac arrhythmias etc.

• artificial knee- hip-joint in the last six months

• regular participation in strength and/or balance training programs

• acute injuries impairing the tests

• disturbances of balance

Related Conditions & MeSH terms

• Fall Prevention
• Fall Risk Factors

Intervention

Behavioral:
• Exercise with supervision

• Home-based without supervision

Locations

Country	Name	City	State
Germany	University of Potsdam, Department of Training and Movement Sciences	Potsdam

Sponsors (3)

Lead Sponsor	Collaborator
University of Potsdam	Prof. Dr. Reto W. Kressig and Dr. Yves Gschwind, University Center for Medicine of Aging Basel (UAB), Felix Platter-Hospital, Basel, Switzerland, Swiss Council for Accident Prevention

Country where clinical trial is conducted

Germany, 

References & Publications (13)

Beijersbergen CM, Granacher U, Vandervoort AA, DeVita P, Hortobágyi T. The biomechanical mechanism of how strength and power training improves walking speed in old adults remains unknown. Ageing Res Rev. 2013 Mar;12(2):618-27. doi: 10.1016/j.arr.2013.03.001. Review. — View Citation

Granacher U, Bridenbaugh SA, Muehlbauer T, Wehrle A, Kressig RW. Age-related effects on postural control under multi-task conditions. Gerontology. 2011;57(3):247-55. doi: 10.1159/000322196. — View Citation

Granacher U, Gollhofer A, Hortobágyi T, Kressig RW, Muehlbauer T. The importance of trunk muscle strength for balance, functional performance, and fall prevention in seniors: a systematic review. Sports Med. 2013 Jul;43(7):627-41. doi: 10.1007/s40279-013-0041-1. Review. — View Citation

Granacher U, Gollhofer A, Strass D. Training induced adaptations in characteristics of postural reflexes in elderly men. Gait Posture. 2006 Dec;24(4):459-66. — View Citation

Granacher U, Gruber M, Gollhofer A. Force production capacity and functional reflex activity in young and elderly men. Aging Clin Exp Res. 2010 Oct-Dec;22(5-6):374-82. doi: 10.3275/6706. — View Citation

Granacher U, Gruber M, Gollhofer A. Resistance training and neuromuscular performance in seniors. Int J Sports Med. 2009 Sep;30(9):652-7. doi: 10.1055/s-0029-1224178. — View Citation

Granacher U, Lacroix A, Muehlbauer T, Roettger K, Gollhofer A. Effects of core instability strength training on trunk muscle strength, spinal mobility, dynamic balance and functional mobility in older adults. Gerontology. 2013;59(2):105-13. doi: 10.1159/000343152. — View Citation

Granacher U, Muehlbauer T, Bridenbaugh S, Bleiker E, Wehrle A, Kressig RW. Balance training and multi-task performance in seniors. Int J Sports Med. 2010 May;31(5):353-8. doi: 10.1055/s-0030-1248322. — View Citation

Granacher U, Muehlbauer T, Gruber M. A qualitative review of balance and strength performance in healthy older adults: impact for testing and training. J Aging Res. 2012;2012:708905. doi: 10.1155/2012/708905. — View Citation

Granacher U, Muehlbauer T, Zahner L, Gollhofer A, Kressig RW. Comparison of traditional and recent approaches in the promotion of balance and strength in older adults. Sports Med. 2011 May 1;41(5):377-400. doi: 10.2165/11539920-000000000-00000. Review. — View Citation

Lacroix A, Kressig RW, Muehlbauer T, Gschwind YJ, Pfenninger B, Bruegger O, Granacher U. Effects of a Supervised versus an Unsupervised Combined Balance and Strength Training Program on Balance and Muscle Power in Healthy Older Adults: A Randomized Contro — View Citation

Muehlbauer T, Besemer C, Wehrle A, Gollhofer A, Granacher U. Relationship between strength, power and balance performance in seniors. Gerontology. 2012;58(6):504-12. doi: 10.1159/000341614. — View Citation

Muehlbauer T, Roth R, Bopp M, Granacher U. An exercise sequence for progression in balance training. J Strength Cond Res. 2012 Feb;26(2):568-74. doi: 10.1519/JSC.0b013e318225f3c4. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body composition		pre, post (12 weeks) and follow-up (24 weeks)
Primary	Balance Performance, Strength / Power Performance		pre, post (12 weeks) and follow-up (24 weeks)
Secondary	cognitive status, psychosocial health, falls efficacy		pre, post (12 weeks) and follow-up (24 weeks)

External Links

•   Here is information available (brochure and video clips) regarding the intervention program