Vitamin D and Exercise in Falls Prevention

Falls Prevention Clinical Trial

— DEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986466
• Other study ID #: R09090
• Secondary ID: SA131524
• Status: Completed
• Phase: N/A
• First received: September 29, 2009
• Last updated: May 24, 2013
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: UKK Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Falls Prevention
• Prevention of Fall-related Injuries

Intervention

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
• 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
• 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)
• exercise and vitamin D supplementation
placebo per day for two years no supervised training (maintenance of their current level of physical activity)

Locations

Country	Name	City	State
Finland	University of Helsinki	Helsinki
Finland	UKK Institute for Health Promotion Research	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
UKK Institute	Academy of Finland, Helsinki University, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (5)

Patil R, Uusi-Rasi K, Pasanen M, Kannus P, Karinkanta S, Sievänen H. Cross-sectional studies and methodology: reply to comment by Erkoyun. Osteoporos Int. 2013 Feb;24(2):743. doi: 10.1007/s00198-012-2134-3. Epub 2012 Sep 29. — View Citation

Patil R, Uusi-Rasi K, Pasanen M, Kannus P, Karinkanta S, Sievänen H. Sarcopenia and osteopenia among 70-80-year-old home-dwelling Finnish women: prevalence and association with functional performance. Osteoporos Int. 2013 Mar;24(3):787-96. doi: 10.1007/s0 — View Citation

Patil R, Uusi-Rasi K, Pasanen M, Kannus P, Karinkanta S, Sievänen H. Sarcopenia prevalence: reply to comment by Perez-Zepeda et al. Osteoporos Int. 2013 Mar;24(3):799. doi: 10.1007/s00198-012-2092-9. Epub 2012 Aug 1. — View Citation

Uusi-Rasi K, Kannus P, Karinkanta S, Pasanen M, Patil R, Lamberg-Allardt C, Sievänen H. Study protocol for prevention of falls: a randomized controlled trial of effects of vitamin D and exercise on falls prevention. BMC Geriatr. 2012 Mar 26;12:12. doi: 10.1186/1471-2318-12-12. — View Citation

Uusi-Rasi K, Karinkanta S, Heinonen A, Sievänen H. Improved femoral neck BMD in older Finnish women between 2002 and 2010. Maturitas. 2013 Jul;75(3):241-5. doi: 10.1016/j.maturitas.2013.04.001. Epub 2013 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of falls		24 months
Secondary	number of fallers		24 months
Secondary	bone mass		24 months
Secondary	fall-related injuries including bone fractures		24 months
Secondary	physical functioning		24 months
Secondary	fear of falling		24 months