Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 4:06 AM
Study NCT ID:
NCT02617303
Status:
UNKNOWN
Last Update Posted:
2021-06-22
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Falls and Its Consequences in Elderly People
Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Study Overview
Official Title:
Effectiveness of an Intervention Through Physical Exercise for the Prevention of Falls and Its Consequences in Elderly People (75-89 Years) Performed in Primary Care: Study Protocol for a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECIOSA
Brief Summary:
Falls are an important risk factor for fragility fractures. Both are associated with the ageing process and as they rise also increase the risk of mortality, disability and dependency. Interventions to prevent falls have been based on multifactorial approaches but the outcomes have shown little effectiveness. Lately, it is being recommended interventions which foster physical exercise incorporating it to daily life activities. The OTAGO exercise programme is based on easy physical exercises for older adults and has shown cost-effective outcomes for falls prevention and its consequences.
Detailed Description:
This is a randomized clinical trial carried out in primary care. The study's scope of activity will include ten urban primary care centers. All selected patients with inclusion criteria will receive a geriatric assessment and other required medical treatment. Next, they will be allocated either to an intervention group or control group. The intervention group will be trained for three months according to the OTAGO exercise program (training phase). Followed by a loyalty phase during which they will be monitored quarterly for a year by their assessment team. The control group will be receive normal medical treatment. Falls and fractures will be monitored quarterly in both groups during 15 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: