Clinical trial NCT01906034: Effects of a Fall Preventive Exercise Program on Intrinsic Fall Risk Factors in Healthy Older Adults.
Official title: Effects of a Fall Preventive Exercise Program on Intrinsic Fall Risk Factors in Healthy Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Risk Factors
Fall Prevention
Lead sponsor: University of Potsdam
Sponsor class: OTHER
Collaborators: name: Swiss Council for Accident Prevention
name: Prof. Dr. Reto W. Kressig and Dr. Yves Gschwind, University Center for Medicine of Aging Basel (UAB), Felix Platter-Hospital, Basel, Switzerland
First posted: 2013-07-23
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Balance Performance, Strength / Power Performance
timeFrame: pre, post (12 weeks) and follow-up (24 weeks)
Secondary outcomes:
measure: cognitive status, psychosocial health, falls efficacy
timeFrame: pre, post (12 weeks) and follow-up (24 weeks)
Other outcomes:
measure: body composition
timeFrame: pre, post (12 weeks) and follow-up (24 weeks)
Locations:
city: Potsdam
country: Germany
facility: University of Potsdam, Department of Training and Movement Sciences
Study officials:
affiliation: University of Potsdam, Department of Training and Movement Science
name: Urs Granacher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Potsdam, Department of Training and Movement Science
name: Andre Lacroix, Master
role: STUDY_CHAIR
References:
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. Epub 2012 Jan 23.
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.
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. Epub 2009 Jun 30.
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. doi: 10.1016/j.gaitpost.2005.12.007. Epub 2006 Feb 2.
citation: Granacher U, Gollhofer A, Hortobagyi 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.
citation: Beijersbergen CM, Granacher U, Vandervoort AA, DeVita P, Hortobagyi 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. Epub 2013 Mar 15.
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. Epub 2012 Oct 24.
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. Epub 2012 Aug 24.
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.
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. Epub 2010 Oct 27.
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. Epub 2010 Feb 23.
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: 10.1007/BF03337733. Epub 2009 Nov 27.
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 Controlled Trial. Gerontology. 2016;62(3):275-88. doi: 10.1159/000442087. Epub 2015 Dec 9.
citation: Gschwind YJ, Kressig RW, Lacroix A, Muehlbauer T, Pfenninger B, Granacher U. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2013 Oct 9;13:105. doi: 10.1186/1471-2318-13-105.