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Vitamin D and Exercise in Falls Prevention (DEX)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Academy of Finland
Tampere University Hospital
Helsinki University
Information provided by (Responsible Party):
Kirsti Uusi-Rasi, UKK Institute
ClinicalTrials.gov Identifier:
NCT00986466
First received: September 29, 2009
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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.

Condition Intervention
Falls Prevention
Prevention of Fall-related Injuries
 Dietary Supplement: exercise and vitamin D supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Vitamin D and Exercise in Preventing Falls of Elderly Women

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by UKK Institute:

Primary Outcome Measures:
  • number of falls [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of fallers [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • bone mass [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • fall-related injuries including bone fractures [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • physical functioning [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • fear of falling [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise with vitamin D 800 IU/d Dietary Supplement: exercise and vitamin D supplementation
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
Other Names:
  • Mini-Sun
  • strength training
  • balance training
  • mobility training
Active Comparator: exercise with placebo Dietary Supplement: exercise and vitamin D supplementation
placebo per day for two years supervised training two times a week for 12 months, and once a week during the next 12 months
Other Names:
  • Mini-Sun
  • strength training
  • balance training
  • mobility training
Active Comparator: no exercise with vitamin D 800 IU/d Dietary Supplement: exercise and vitamin D supplementation
20 µg (800 IU) of vitamin D per day for two years no supervised training (maintenance of their current level of physical activity)
Other Names:
  • Mini-Sun
  • strength training
  • balance training
  • mobility training
Placebo Comparator: no exercise with placebo Dietary Supplement: exercise and vitamin D supplementation
placebo per day for two years no supervised training (maintenance of their current level of physical activity)
Other Names:
  • Mini-Sun
  • strength training
  • balance training
  • mobility training

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.
  Eligibility

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • age 70-80 years old
  • lives at home independently
  • has fallen at least once during the previous year
  • no contraindication to exercise
  • understands the procedures of the study
  • has been informed of X-ray radiation doses of the DXA and pQCT investigations

Exclusion Criteria:

  • moderate-to-vigorous exercise more than 2 hours per week
  • regular use of vitamin D, or calcium + vitamin D supplements
  • a recent fracture (during preceding 12 months)
  • contraindication or inability to participate in the exercise program
  • marked decline in the basic activities of daily living (ADL-test)
  • cognitive impairments (Mini Mental State Examination, MMSE-test < 18)
  • persons with chronic disease conditions, such as Parkinson's disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986466

Locations
Finland
University of Helsinki
Helsinki, Finland
UKK Institute for Health Promotion Research
Tampere, Finland
Sponsors and Collaborators
UKK Institute
Academy of Finland
Tampere University Hospital
Helsinki University
Investigators
Principal Investigator: Kirsti Uusi-Rasi, PhD UKK Institute for Health Promotion Research
  More Information

Publications:

Responsible Party: Kirsti Uusi-Rasi, Ph.D./ senior researcher, UKK Institute
ClinicalTrials.gov Identifier: NCT00986466     History of Changes
Other Study ID Numbers: R09090, SA131524
Study First Received: September 29, 2009
Last Updated: September 12, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by UKK Institute:
exercise
falls
physical functioning
vitamin D
mobility function
 neuromuscular functioning¨
quality of life
number of fallers
fall-related injuries including bone fractures
bone mass

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013