Clinical Trials Directory

Trials / Completed

CompletedNCT00986466

Vitamin D and Exercise in Falls Prevention

Effects of Vitamin D and Exercise in Preventing Falls of Elderly Women

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
409 (actual)
Sponsor
UKK Institute · Academic / Other
Sex
Female
Age
70 Years – 80 Years
Healthy volunteers
Accepted

Summary

The aim of the study is to investigate the effects of exercise and vitamin D supplementation on reducing falls and injuries in community-dwelling, independent-living women aged 70-79 years of age. The investigators will test the following hypothesis: 1. Exercise including strength, balance and mobility training will improve muscle functioning and body balance, and thus reduce falls by 30% compared with non-exercisers. 2. Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared with placebo. 3. Together vitamin D and exercise have a stronger influence on fall prevention than either used alone. 4. Training improves mobility functions and bone health. 5. Supervised training twice a week with daily home training will improve physical functioning thus resulting in reduced fear of falling. 6. Reduced fear of falling and improved physical functioning help older people to stay physically active, which further improve their quality of life.

Detailed description

Falls account for over 80% of all injury-related admissions to hospital among older people. Although there is evidence that both exercise and vitamin D improve neuromuscular and cognitive function, and may thus reduce the risk of falls and fractures, these two factors have never been evaluated together in a clinical trial. This study is a randomized 24-month intervention in elderly women. The investigators hypothesize that exercise and vitamin D supplementation reduce falls and injuries including fractures in community-dwelling, independent-living women 70-79 years of age. The eligible participants will be randomly assigned into one of four groups: 1. exercise with vitamin D 2. exercise with placebo 3. no exercise with vitamin D 4. no exercise with placebo. The rational of this study is to provide important information on how to maintain and improve physical functioning and thus prevent falls and fractures of elderly people. In addition, if fear of falling can be declined with this program, it will further help elderly people to keep physically active and maintain their functional capacity and quality of life.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTexercise and vitamin D supplementation20 µg (800 IU) of vitamin D per day for two years supervised training two times a week for 12 months, and once a week during the next 12 months
DIETARY_SUPPLEMENTexercise and vitamin D supplementationplacebo per day for two years supervised training two times a week for 12 months, and once a week during the next 12 months
DIETARY_SUPPLEMENTexercise and vitamin D supplementation20 µg (800 IU) of vitamin D per day for two years no supervised training (maintenance of their current level of physical activity)
DIETARY_SUPPLEMENTexercise and vitamin D supplementationplacebo per day for two years no supervised training (maintenance of their current level of physical activity)

Timeline

Start date
2009-09-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2009-09-30
Last updated
2013-05-27

Locations

2 sites across 1 country: Finland

Source: ClinicalTrials.gov record NCT00986466. Inclusion in this directory is not an endorsement.