Skip to main content
OpenTrials
Completed

NCT Number: NCT01906034

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Potsdam, Department of Training and Movement Sciences

Potsdam, 14469, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise with supervision

Behavioral

Home-based without supervision

Behavioral

Primary outcomes

  1. Balance Performance, Strength / Power Performance

    Time frame: pre, post (12 weeks) and follow-up (24 weeks)

Secondary outcomes

  1. cognitive status, psychosocial health, falls efficacy

    Time frame: pre, post (12 weeks) and follow-up (24 weeks)

Other outcomes

  1. body composition

    Time frame: pre, post (12 weeks) and follow-up (24 weeks)

Sponsors and collaborators

Lead sponsor

University of Potsdam

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2013
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.