Vitamin D and Exercise in Falls Prevention
Condition: Falls Prevention; Prevention of Fall-related Injuries
Study type: Interventional

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.
    

Intervention name(s): exercise and vitamin D supplementation; exercise and vitamin D supplementation; exercise and vitamin D supplementation; exercise and vitamin D supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 20 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; placebo per day for two years supervised training two times a week for 12 months, and once a week during the next 12 months; 20 µg (800 IU) of vitamin D per day for two years no supervised training (maintenance of their current level of physical activity); placebo per day for two years no supervised training (maintenance of their current level of physical activity)
Other intervention name(s): Mini-Sun; strength training; balance training; mobility training; Mini-Sun; strength training; balance training; mobility training; Mini-Sun; strength training; balance training; mobility training; Mini-Sun; strength training; balance training; mobility training
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: exercise; falls; physical functioning; vitamin D; mobility function; neuromuscular functioning¨; quality of life; number of fallers; fall-related injuries including bone fractures; bone mass