Falls PreventionDEXNCT00986466
Vitamin D and Exercise in Falls Prevention
A study testing exercise and vitamin D supplementation in people with Falls Prevention and Prevention of Fall-related Injuries, run by UKK Institute at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 70 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Falls Prevention, Prevention of Fall-related Injuries
- What is being tested?
- exercise and vitamin D supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 409 participants
- Where
- 2 sitesFinland
- Study dates
- Sep 2009to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
University of Helsinki
Helsinki
UKK Institute for Health Promotion Research
Tampere
About this study
Official title: 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:
- Exercise including strength, balance and mobility training will improve muscle functioning and body balance, and thus reduce falls by 30% compared with non-exercisers.
- Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared with placebo.
- Together vitamin D and exercise have a stronger influence on fall prevention than either used alone.
- Training improves mobility functions and bone health.
- Supervised training twice a week with daily home training will improve physical functioning thus resulting in reduced fear of falling.
- Reduced fear of falling and improved physical functioning help older people to stay physically active, which further improve their quality of life.
Read the 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:
- exercise with vitamin D
- exercise with placebo
- no exercise with vitamin D
- 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.
- Being tested
- exercise and vitamin D supplementation
- 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
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and vitamin D supplementationDietary supplement
Also called Mini-Sun, strength training, balance training, mobility training
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 supplementationDietary supplement
Also called Mini-Sun, strength training, balance training, mobility training
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 supplementationDietary supplement
Also called Mini-Sun, strength training, balance training, mobility training
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 supplementationDietary supplement
Also called Mini-Sun, strength training, balance training, mobility training
placebo per day for two years no supervised training (maintenance of their current level of physical activity)
| Study group | Role | What they receive |
|---|---|---|
| exercise with vitamin D 800 IU/d | Experimental | Not described Receives: Dietary Supplement: exercise and vitamin D supplementation |
| exercise with placebo | Active comparator | Not described Receives: Dietary Supplement: exercise and vitamin D supplementation |
| no exercise with vitamin D 800 IU/d | Active comparator | Not described Receives: Dietary Supplement: exercise and vitamin D supplementation |
| no exercise with placebo | Placebo comparator | Not described Receives: Dietary Supplement: exercise and vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of falls
Measured: 24 months
Secondary outcomes (5)
number of fallers
Measured: 24 months
bone mass
Measured: 24 months
fall-related injuries including bone fractures
Measured: 24 months
physical functioning
Measured: 24 months
fear of falling
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Falls PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland, Tampere University Hospital, University of Helsinki
- Responsible party
- Principal investigator, Kirsti Uusi-Rasi, UKK Institute
- Investigators
- Kirsti Uusi-Rasi, PhD, Principal investigator, UKK Institute for Health Promotion Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986466
- Sponsor's protocol ID
- R09090
- Other IDs
- SA131524
- Acronym
- DEX
- Status last verified
- May 2013
- First submitted
- 29 Sep 2009
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22448872Patil 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.
PubMed 22688541Uusi-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.
PubMed 23642771Patil 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.
PubMed 23052929Patil 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.
PubMed 22850867Patil 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.
PubMed 26205890Patil 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.
PubMed 26115073Uusi-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.
PubMed 25799402Patil 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.
PubMed 24107382
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D and Exercise in Preventing Falls of Elderly Women
- ClinicalTrials.gov ID
- NCT00986466
- Acronym / sponsor ID
- DEX / R09090
- Keywords
- exercise, falls, physical functioning, vitamin D, mobility function, neuromuscular functioning¨, quality of life, number of fallers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Academy of Finland, Tampere University Hospital, University of Helsinki
- Study start
- Sep 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Exercise including strength, balance and mobility training will improve muscle functioning and body balance, and thus reduce falls by 30% compared with non-exercisers.
- Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared with placebo.
- Together vitamin D and exercise have a stronger influence on fall prevention than either used alone.
- Training improves mobility functions and bone health.
- Supervised training twice a week with daily home training will improve physical functioning thus resulting in reduced fear of falling.
- 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:
- exercise with vitamin D
- exercise with placebo
- no exercise with vitamin D
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- female
- age 70-80 years old
- lives at home independently
- has fallen at least once during the previous year
- no contraindication to exercise
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise and vitamin D supplementationAlso: Mini-Sun, strength training, balance training, mobility training20 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 | Dietary supplement | exercise with vitamin D 800 IU/d |
| exercise and vitamin D supplementationAlso: Mini-Sun, strength training, balance training, mobility trainingplacebo per day for two years supervised training two times a week for 12 months, and once a week during the next 12 months | Dietary supplement | exercise with placebo |
| exercise and vitamin D supplementationAlso: Mini-Sun, strength training, balance training, mobility training20 µg (800 IU) of vitamin D per day for two years no supervised training (maintenance of their current level of physical activity) | Dietary supplement | no exercise with vitamin D 800 IU/d |
| exercise and vitamin D supplementationAlso: Mini-Sun, strength training, balance training, mobility trainingplacebo per day for two years no supervised training (maintenance of their current level of physical activity) | Dietary supplement | no exercise with placebo |
Primary outcome
number of falls
Time frame: 24 months
5 secondary outcomes
number of fallers
Time frame: 24 months
bone mass
Time frame: 24 months
fall-related injuries including bone fractures
Time frame: 24 months
physical functioning
Time frame: 24 months
fear of falling
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Background: PubMed 22448872Uusi-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.
- Results publication: PubMed 22688541Patil 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.
- Results publication: PubMed 23642771Uusi-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.
- Results publication: PubMed 23052929Patil 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.
- Results publication: PubMed 22850867Patil 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.
- Derived from this study: PubMed 26205890Patil 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.
- Derived from this study: PubMed 26115073Patil 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.
- Derived from this study: PubMed 25799402Uusi-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.
- Derived from this study: PubMed 24107382Patil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsti Uusi-Rasi, PhD principal investigator
UKK Institute for Health Promotion Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and vitamin D supplementation in people with Falls Prevention and Prevention of Fall-related Injuries, run by UKK Institute at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of falls (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00986466, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.