Prevention of Falls and Its Consequences in Elderly People

NCT ID: NCT02617303

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-12-31

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.

Conditions

Accidental Falls; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

OTAGO'S program arm

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.

Group Type: EXPERIMENTAL

OTAGO's exercises

Intervention Type: PROCEDURE

The intervention is based on OTAGO's program, consisting of a set of aerobic exercises affecting gait, balance, stability and are adapted for older people to support them both in groups and individually. The program lasts 6 weeks (2 sessions per week) and is followed by a loyalty phase to consolidate the exercise program. Falls and fractures will be monitored quarterly for 15 months.

CONTROL GROUP

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.

Group Type: ACTIVE_COMPARATOR

COMMON PRACTICE

Intervention Type: PROCEDURE

Normal medical treatment will be provided by family physicians and nurses.

Interventions

OTAGO's exercises

The intervention is based on OTAGO's program, consisting of a set of aerobic exercises affecting gait, balance, stability and are adapted for older people to support them both in groups and individually. The program lasts 6 weeks (2 sessions per week) and is followed by a loyalty phase to consolidate the exercise program. Falls and fractures will be monitored quarterly for 15 months.

Intervention Type: PROCEDURE

COMMON PRACTICE

Normal medical treatment will be provided by family physicians and nurses.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Azagra, PhD

Role: PRINCIPAL_INVESTIGATOR

Insitut Català de la Salut, Universitat Autònoma de Barcelona

Locations

CAP Barberà del Vallès

Barbera Del Valles, Barcelona, Spain

CAP Canaletes

Cerdanyola del Vallès, Barcelona, Spain

CAP Serraparera

Cerdanyola del Vallès, Barcelona, Spain

CAP Creu Alta

Sabadell, Barcelona, Spain

CAP Badia del Vallés

Barcelona, , Spain

CAP Castellar

Castellar del Vallès, , Spain

CAP La Llagosta

La Llagosta, , Spain

Cap Centre

Sabadell, , Spain

Cap Can Rull

Sabadell, , Spain

CAP Ca N'Oriach

Sabadell, , Spain

CAP Sud

Sabadell, , Spain

Countries

Spain

Other Identifiers

P14/099

Identifier Type: -

Identifier Source: org_study_id