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| ID | Type | Description | Link |
|---|---|---|---|
| SA131524 |
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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
| Tampere University Hospital | OTHER |
| University of Helsinki | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercise with vitamin D 800 IU/d | Experimental |
| |
| exercise with placebo | Active Comparator |
| |
| no exercise with vitamin D 800 IU/d | Active Comparator |
| |
| no exercise with placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| number of falls | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of fallers | 24 months | |
| bone mass | 24 months | |
| fall-related injuries including bone fractures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsti Uusi-Rasi, PhD | UKK Institute for Health Promotion Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Helsinki | Helsinki | Finland | ||||
| UKK Institute for Health Promotion Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22448872 | Background | 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. | |
| 22688541 | Result | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2015 | |
| Reset | Jun 10, 2015 | |
| Release | Dec 1, 2015 | |
| Reset | Jan 5, 2016 | |
| Release | May 12, 2016 | |
| Reset | Jun 21, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2015 | Jun 10, 2015 | |||
| Dec 1, 2015 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| exercise and vitamin D supplementation | Dietary Supplement | 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 | Dietary Supplement | 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 | Dietary Supplement | placebo per day for two years no supervised training (maintenance of their current level of physical activity) |
|
|
| 24 months |
| physical functioning | 24 months |
| fear of falling | 24 months |
| Tampere |
| Finland |
| 23642771 | 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. |
| 23052929 | 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. |
| 22850867 | 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. |
| 26205890 | Derived | 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. |
| 26115073 | 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. |
| 25799402 | 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. |
| 24107382 | 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. |
| Jan 5, 2016 |
| May 12, 2016 | Jun 21, 2016 |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |