Vitamin D and Exercise in Falls Prevention (DEX)

May 24, 2013 updated by: Kirsti Uusi-Rasi, UKK Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

409

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • University of Helsinki
      • Tampere, Finland
        • UKK institute for Health Promotion Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
ACTIVE_COMPARATOR: exercise with placebo
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • 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 supervised training two times a week for 12 months, and once a week during the next 12 months
Other Names:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
PLACEBO_COMPARATOR: no exercise with placebo
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training
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:
  • strength training
  • balance training
  • Mini-Sun
  • mobility training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of falls
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
number of fallers
Time Frame: 24 months
24 months
bone mass
Time Frame: 24 months
24 months
fall-related injuries including bone fractures
Time Frame: 24 months
24 months
physical functioning
Time Frame: 24 months
24 months
fear of falling
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UKK Institute

Collaborators

University of Helsinki
Tampere University Hospital
Academy of Finland

Investigators

  • Principal Investigator: Kirsti Uusi-Rasi, PhD, UKK institute for Health Promotion Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (ESTIMATE)

September 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 24, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R09090
  • SA131524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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