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

March 19, 2017 updated by: Urs Granacher, University of Potsdam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Potsdam, Germany, 14469
        • University of Potsdam, Department of Training and Movement Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Balance Performance, Strength / Power Performance
Time Frame: pre, post (12 weeks) and follow-up (24 weeks)
pre, post (12 weeks) and follow-up (24 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
cognitive status, psychosocial health, falls efficacy
Time Frame: pre, post (12 weeks) and follow-up (24 weeks)
pre, post (12 weeks) and follow-up (24 weeks)

Other Outcome Measures

Outcome Measure
Time Frame
body composition
Time Frame: pre, post (12 weeks) and follow-up (24 weeks)
pre, post (12 weeks) and follow-up (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Potsdam

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (ESTIMATE)

July 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 19, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BFU-2.104

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Academic Journal Paper
    Information identifier: DOI:10.1159/000442087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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