Clinical trial NCT00986466: Vitamin D and Exercise in Falls Prevention
Official title: Effects of Vitamin D and Exercise in Preventing Falls of Elderly Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls Prevention
Prevention of Fall-related Injuries
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
Lead sponsor: UKK Institute
Sponsor class: OTHER
Collaborators: name: Academy of Finland
name: Tampere University Hospital
name: University of Helsinki
First posted: 2009-09-30
Enrollment: 409
Sex: FEMALE
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: number of falls
timeFrame: 24 months
Secondary outcomes:
measure: number of fallers
timeFrame: 24 months
measure: bone mass
timeFrame: 24 months
measure: fall-related injuries including bone fractures
timeFrame: 24 months
measure: physical functioning
timeFrame: 24 months
measure: fear of falling
timeFrame: 24 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
city: Tampere
country: Finland
facility: UKK Institute for Health Promotion Research
Study officials:
affiliation: UKK Institute for Health Promotion Research
name: Kirsti Uusi-Rasi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uusi-Rasi K, Kannus P, Karinkanta S, Pasanen M, Patil R, Lamberg-Allardt C, Sievanen 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.
citation: Patil R, Uusi-Rasi K, Pasanen M, Kannus P, Karinkanta S, Sievanen 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/s00198-012-2046-2. Epub 2012 Jun 12.
citation: Uusi-Rasi K, Karinkanta S, Heinonen A, Sievanen 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.
citation: Patil R, Uusi-Rasi K, Pasanen M, Kannus P, Karinkanta S, Sievanen 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. No abstract available.
citation: Patil R, Uusi-Rasi K, Pasanen M, Kannus P, Karinkanta S, Sievanen 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. No abstract available.
citation: Patil R, Kolu P, Raitanen J, Valvanne J, Kannus P, Karinkanta S, Sievanen H, Uusi-Rasi K. Cost-effectiveness of vitamin D supplementation and exercise in preventing injurious falls among older home-dwelling women: findings from an RCT. Osteoporos Int. 2016 Jan;27(1):193-201. doi: 10.1007/s00198-015-3240-9. Epub 2015 Jul 24.
citation: Patil R, Uusi-Rasi K, Tokola K, Karinkanta S, Kannus P, Sievanen H. Effects of a Multimodal Exercise Program on Physical Function, Falls, and Injuries in Older Women: A 2-Year Community-Based, Randomized Controlled Trial. J Am Geriatr Soc. 2015 Jul;63(7):1306-13. doi: 10.1111/jgs.13489. Epub 2015 Jun 26.
citation: Uusi-Rasi K, Patil R, Karinkanta S, Kannus P, Tokola K, Lamberg-Allardt C, Sievanen H. Exercise and vitamin D in fall prevention among older women: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):703-11. doi: 10.1001/jamainternmed.2015.0225.
citation: Patil R, Uusi-Rasi K, Kannus P, Karinkanta S, Sievanen H. Concern about falling in older women with a history of falls: associations with health, functional ability, physical activity and quality of life. Gerontology. 2014;60(1):22-30. doi: 10.1159/000354335. Epub 2013 Oct 8.