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Open Access Highly Accessed Study protocol

Study protocol for prevention of falls: A randomized controlled trial of effects of vitamin D and exercise on falls prevention

Kirsti Uusi-Rasi12*, Pekka Kannus134, Saija Karinkanta1, Matti Pasanen1, Radhika Patil1, Christel Lamberg-Allardt5 and Harri Sievänen1

Author Affiliations

1 The UKK Institute for Health Promotion Research, PO Box 30, FI-33501 Tampere, Finland

2 Pirkanmaa Hospital District, Science Center, PO Box 2000, FI-33521 Tampere, Finland

3 Medical School, University of Tampere, 33014 Tampere, Finland

4 Division of Orthopaedics and Traumatology, Department of Trauma, Musculoskeletal Surgery and Rehabilitation, Tampere University Hospital, PO Box 2000, FI-33521 Tampere, Finland

5 Department of Food and Environmental Sciences, University of Helsinki, PO Box 66, FI-00014 Helsinki, Finland

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BMC Geriatrics 2012, 12:12  doi:10.1186/1471-2318-12-12

Published: 26 March 2012

Abstract

Background

Falls are the leading cause of unintentional injury and injury-related death among older people. In addition to physical activity, vitamin D also may affect balance and neuromuscular function. Low serum 25-hydroksivitamin D level increases the risk of bone loss, falls and fractures. Thus, an appropriate exercise program and sufficient vitamin D intake may significantly improve not only functional balance, but also balance confidence. Balance represents a complex motor skill determined by reaction time, muscle strength, and speed and coordination of movement.

Methods/Design

A 2-year randomized double-blind placebo-controlled vitamin D and open exercise trial of 409 home-dwelling women 70 to 80 years of age comprising four study arms: 1) exercise + vitamin D (800 IU/d), 2) exercise + placebo, 3) no exercise + vitamin D (800 IU/d), 4) no exercise + placebo. In addition to monthly fall diaries, general health status, life style, bone health, physical functioning, and vitamin D metabolism will be assessed. The primary outcomes are the rate of falls and fall-related injuries. Secondary outcomes include changes in neuromuscular functioning (e.g. body balance, muscle strength), ADL- and mobility functions, bone density and structure, cardiovascular risk factors, quality of life and fear of falling.

Discussion

The successful completion of this trial will provide evidence on the effectiveness of exercise and vitamin D for falls reduction.

Trial Registration

ClinicalTrial.gov -register (NCT00986466).

Keywords:
Exercise; Falls; Physical functioning; Vitamin D; Mobility function; Neuromuscular functioning; Quality of life