Prevention of Falls and Its Consequences in Elderly People (PRECIOSA)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Osteoporosis; Accidental Falls

Treatments: Procedure: OTAGO's exercises; Procedure: COMMON PRACTICE

Study type: Interventional

Funder types: Other

Identifiers

NCT02617303

P14/099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 402 estimated patients

Sex: All

Ages: 75 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients ≥ 75 to 89 years at baseline assigned to Primary Care Team and living in the community
• Ranking the Folstein Mini Mental State Examination test
• Expectation of permanence in the area at least 18 months.
• Agree to participate in the study by informed consent, after reading the patient information sheet.

Exclusion criteria

• Current participation in another trial or institutional program of guided physical activity.
• Patients with who have had a hip and/or knee operation or major injury or any other intervention in the last 6 months.
• Patients with who are unable to follow an aerobic physical activity program. Patients using assisted mobility devices are not excluded.
• Patients in Home Care Programs or Nursing Homes at baseline or during the training phase.
• Terminal or severe cancer cases.
• Patients disabled prior to or during the study period.
• Have not been visited in reference's Health Center in the last two years (displacement / transfer
• Very advanced dementia that not allows to follow the instructions in the exercise program and nurse's instructions. In case of a caregiver who assume the realization of exercise program and the following of tips, it may be included.
• Displaced, will temporarily shifted (>2months/year) o will definitively shifted patients of Health Center.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 2 patient groups

OTAGO'S program arm

Experimental group

Description:

Patients meeting the inclusion criteria will be randomly assigned to the experimental group. They will receive OTAGO'S exercise program during three months, followed by adherence phase. Falls and fractures will be quarterly followed during 15 months.

Treatment:

Procedure: OTAGO's exercises

CONTROL GROUP

Active Comparator group

Description:

Patients meeting the inclusion criteria will be randomly assigned to the control group. Normal medical treatment will be provided by family physicians and nurses. Falls and fractures will be quarterly followed during 15 months.

Treatment:

Procedure: COMMON PRACTICE