Clinical trial NCT02617303: Prevention of Falls and Its Consequences in Elderly People
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Osteoporosis
Keywords: elderly
accidental falls
osteoporosis
fractures
Primary Care
Randomized clinical trial
Otago exercise programme
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 402
Sex: ALL
Minimum age (years): 75
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Reduction of falls measured with a questionnaire from April 2016 to June 2017.
timeFrame: 15 months
Secondary outcomes:
measure: Reduction of fracture measured with a questionnaire (location, causes and consequences) from April 2016 to June 2017.
timeFrame: 15 months
measure: Reduction of fear to fall measured with Falls Efficacy Scale (FES) from April 2016 to June 2017.
timeFrame: 15 months
measure: Parameters of physical frailty (strength) measured with switched test Timed Get Up and Go (TGUAG) from April 2016 to June 2017.
timeFrame: 15 months
measure: Parameters of physical frailty (balance) measured through Biodex Balance System ('stability index') from April 2016 to June 2017.
timeFrame: 15 months
measure: Parameters of physical frailty (motion) measured through "BTS G-WALK" from April 2016 to June 2017.
timeFrame: 15 months
measure: Parameters of physical frailty (endurance) measured with dynamometer from April 2016 to June 2017.
timeFrame: 15 months
measure: Appointment at the surgery measured through questionnaire of number of appointment in the practice
timeFrame: 15 months
measure: Nursing Home admittance measured through questionnaire
timeFrame: 15 months
measure: Drug reduction measured through questionnaire of kind of drug from April 2016 to June 2017.
timeFrame: 15 months
Other outcomes:
Locations:
city: Barberà del Vallès
country: Spain
facility: CAP Barberà del Vallès
state: Barcelona
city: Cerdanyola del Vallès
country: Spain
facility: CAP Canaletes
state: Barcelona
city: Cerdanyola del Vallès
country: Spain
facility: CAP Serraparera
state: Barcelona
city: Sabadell
country: Spain
facility: CAP Creu Alta
state: Barcelona
city: Barcelona
country: Spain
facility: CAP Badia del Vallés
city: Castellar del Vallès
country: Spain
facility: CAP Castellar
city: La Llagosta
country: Spain
facility: CAP La Llagosta
city: Sabadell
country: Spain
facility: Cap Centre
city: Sabadell
country: Spain
facility: Cap Can Rull
city: Sabadell
country: Spain
facility: CAP Ca N'Oriach
city: Sabadell
country: Spain
facility: CAP Sud
Study officials:
affiliation: Insitut Català de la Salut, Universitat Autònoma de Barcelona
name: Rafael Azagra, PhD
role: PRINCIPAL_INVESTIGATOR
References: