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

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ClinicalTrials.gov Identifier: NCT01906034
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : March 21, 2017
Sponsor:
Collaborators:
Swiss Council for Accident Prevention
Prof. Dr. Reto W. Kressig and Dr. Yves Gschwind, University Center for Medicine of Aging Basel (UAB), Felix Platter-Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Urs Granacher, University of Potsdam

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.


Condition or disease Intervention/treatment
Fall Risk Factors Fall Prevention Behavioral: Exercise with supervision Behavioral: Home-based without supervision

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Fall Preventive Exercise Program on Intrinsic Fall Risk Factors in Healthy Older Adults.
Study Start Date : September 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exercise with supervision
The expert panel selected balance and strength / power exercises which can be performed with one's own bodyweight or with the help of small, low-cost exercise equipment (i.e., small weights, resistance bands, unstable surfaces). In this study, intensity during training will be regulated using the Borg Rating of Perceived Exertion scale (i.e., 6-20 points, maximal exertion at 20 points). According to the individual fitness level, exercises should be performed with a perceived exertion between 12 and 16 points (somewhat hard - hard) during balance and strength / power training. Exercise intensity will be progressed individually using the Borg Rating of Perceived Exertion scale and varying the balance and strength / power exercises in order to sufficiently stimulate the neuromuscular system. Strength / power exercises will be progressed from single to multiple joint, isometric to dynamic muscle contraction, short to long lever arm and slow to fast exercises.
Behavioral: Exercise with supervision
Experimental: Home-based without supervision
The expert panel selected balance and strength / power exercises which can be performed with one's own bodyweight or with the help of small, low-cost exercise equipment (i.e., small weights, resistance bands, unstable surfaces). In this study, intensity during training will be regulated using the Borg Rating of Perceived Exertion scale (i.e., 6-20 points, maximal exertion at 20 points). According to the individual fitness level, exercises should be performed with a perceived exertion between 12 and 16 points (somewhat hard - hard) during balance and strength / power training. Exercise intensity will be progressed individually using the Borg Rating of Perceived Exertion scale and varying the balance and strength / power exercises in order to sufficiently stimulate the neuromuscular system. Strength / power exercises will be progressed from single to multiple joint, isometric to dynamic muscle contraction, short to long lever arm and slow to fast exercises.
Behavioral: Home-based without supervision
No Intervention: control group
The control group is a traditional waiting group and will receive a supervised training program after the completion of this study



Primary Outcome Measures :
  1. Balance Performance, Strength / Power Performance [ Time Frame: pre, post (12 weeks) and follow-up (24 weeks) ]

Secondary Outcome Measures :
  1. cognitive status, psychosocial health, falls efficacy [ Time Frame: pre, post (12 weeks) and follow-up (24 weeks) ]

Other Outcome Measures:
  1. body composition [ Time Frame: pre, post (12 weeks) and follow-up (24 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906034


Locations
Germany
University of Potsdam, Department of Training and Movement Sciences
Potsdam, Germany, 14469
Sponsors and Collaborators
University of Potsdam
Swiss Council for Accident Prevention
Prof. Dr. Reto W. Kressig and Dr. Yves Gschwind, University Center for Medicine of Aging Basel (UAB), Felix Platter-Hospital, Basel, Switzerland
Investigators
Principal Investigator: Urs Granacher, PhD University of Potsdam, Department of Training and Movement Science
Study Chair: Andre Lacroix, Master University of Potsdam, Department of Training and Movement Science

Additional Information:
Publications:

Study Data/Documents: Academic Journal Paper  This link exits the ClinicalTrials.gov site
Identifier: DOI:10.1159/000442087

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Urs Granacher, PhD, University of Potsdam
ClinicalTrials.gov Identifier: NCT01906034     History of Changes
Other Study ID Numbers: BFU-2.104
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017