Vitamin D and Exercise in Falls Prevention

NCT00986466 | Completed

• 2 other identifiers: R09090SA131524
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 2

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. 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. 2.Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared with placebo.
3. 3.Together vitamin D and exercise have a stronger influence on fall prevention than either used alone.
4. 4.Training improves mobility functions and bone health.
5. 5.Supervised training twice a week with daily home training will improve physical functioning thus resulting in reduced fear of falling.
6. 6.Reduced fear of falling and improved physical functioning help older people to stay physically active, which further improve their quality of life.

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

Outcome Measures

Primary Outcomes (1)

• number of falls

  24 months

Secondary Outcomes (5)

• number of fallers

  24 months

• bone mass

  24 months

• fall-related injuries including bone fractures

  24 months

• physical functioning

  24 months

• fear of falling

  24 months

Study Arms (4)

exercise with vitamin D 800 IU/d

EXPERIMENTAL

Dietary Supplement: exercise and vitamin D supplementation

exercise with placebo

ACTIVE COMPARATOR

Dietary Supplement: exercise and vitamin D supplementation

no exercise with vitamin D 800 IU/d

ACTIVE COMPARATOR

Dietary Supplement: exercise and vitamin D supplementation

no exercise with placebo

PLACEBO COMPARATOR

Dietary Supplement: exercise and vitamin D supplementation

Interventions

exercise and vitamin D supplementation DIETARY_SUPPLEMENT

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

Also known as: Mini-Sun, strength training, balance training, mobility training

exercise with vitamin D 800 IU/d

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UKK Institute: lead
• Academy of Finland: collaborator
• Tampere University Hospital: collaborator
• University of Helsinki: collaborator

Study Sites (2)

University of Helsinki

Helsinki, Finland

Location

UKK Institute for Health Promotion Research

Tampere, Finland

Location

Related Publications (9)

• 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.

  PMID: 22448872 BACKGROUND

• 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.

  PMID: 22688541 RESULT

• 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.

  PMID: 23642771 RESULT

• 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.

  PMID: 23052929 RESULT

• 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.

  PMID: 22850867 RESULT

• 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.

  PMID: 26205890 DERIVED

• 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.

  PMID: 26115073 DERIVED

• 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.

  PMID: 25799402 DERIVED

• 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.

  PMID: 24107382 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Kirsti Uusi-Rasi, PhD

  UKK Institute for Health Promotion Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D./ senior researcher

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

FI (2)