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

Primary Purpose

Accidental Falls, Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
OTAGO's exercises
COMMON PRACTICE
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Accidental Falls focused on measuring elderly, accidental falls, osteoporosis, fractures, Primary Care, Randomized clinical trial, Otago exercise programme

Eligibility Criteria

75 Years - 89 Years (Older Adult)All SexesAccepts 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.

Sites / Locations

  • CAP Barberà del Vallès
  • CAP Canaletes
  • CAP Serraparera
  • CAP Creu Alta
  • CAP Badia del Vallés
  • CAP Castellar
  • CAP La Llagosta
  • Cap Centre
  • Cap Can Rull
  • CAP Ca N'Oriach
  • CAP Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OTAGO'S program arm

CONTROL GROUP

Arm 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.

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.

Outcomes

Primary Outcome Measures

Reduction of falls measured with a questionnaire from April 2016 to June 2017.
Evaluate the incidence of OTAGO's physical intervention program on fall reduction in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with a questionnaire at baseline and during follow-up.

Secondary Outcome Measures

Reduction of fracture measured with a questionnaire (location, causes and consequences) from April 2016 to June 2017.
Evaluate the incidence of OTAGO's physical intervention program on fracture reduction in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with a questionnaire (location, causes and consequences) at baseline and during follow-up.
Reduction of fear to fall measured with Falls Efficacy Scale (FES) from April 2016 to June 2017.
Evaluate the incidence of OTAGO's physical intervention program on reduction of fear to fall in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with Falls Efficacy Scale (FES) at baseline and during follow-up.
Parameters of physical frailty (strength) measured with switched test Timed Get Up and Go (TGUAG) from April 2016 to June 2017.
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (strength) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with switched test Timed Get Up and Go (TGUAG) at baseline and during follow-up.
Parameters of physical frailty (balance) measured through Biodex Balance System ('stability index') from April 2016 to June 2017.
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (balance) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through Tinneti Scale and Biodex Balance System. Biodex Balance System provides valid, reliable and repeatable objective measures of a patient's ability to balance on stable and unstable surfaces. It provides visual biofeedback of a patient's ability to control their centre of gravity and their limits of stability. This test provides an objective 'stability index' that if higher than the predicted value indicates a strength, proprioception, and vestibular or visual impairment. Both monitoring at baseline and during follow-up.
Parameters of physical frailty (motion) measured through "BTS G-WALK" from April 2016 to June 2017.
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (flexibility) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through "BTS G-WALK". It is a wireless laptop, its software allows to analyze basic parameters of motion. It will be monitoring at baseline and during follow-up.
Parameters of physical frailty (endurance) measured with dynamometer from April 2016 to June 2017.
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (endurance) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be tested as strength measured with dynamometer in leg and arm. It will be monitoring at baseline and during follow-up.
Appointment at the surgery measured through questionnaire of number of appointment in the practice
Evaluate the incidence of OTAGO's physical intervention program on reduction of appointment in the practice of primary and second care and hospital admission in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through questionnaire of number of appointment in the practice in the previous year and during follow-up.
Nursing Home admittance measured through questionnaire
Evaluate the incidence of OTAGO's physical intervention program on reduction of inclusion rate in home care or institutionalization in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through questionnaire of home care and/or institutionalization in the previous year and during follow-up.
Drug reduction measured through questionnaire of kind of drug from April 2016 to June 2017.
Evaluate the effect of drug reduction in the intervention of disprescription performed in the cohort by the usual care team in elderly (75-89 years). It will be measured through questionnaire of kind of drug, if there are any removed drug, and number and kind of drug removed to the end. Monitoring at baseline and during follow-up.

Full Information

First Posted
June 11, 2015
Last Updated
June 21, 2021
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT02617303
Brief Title
Prevention of Falls and Its Consequences in Elderly People
Acronym
PRECIOSA
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Osteoporosis
Keywords
elderly, accidental falls, osteoporosis, fractures, Primary Care, Randomized clinical trial, Otago exercise programme

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OTAGO'S program arm
Arm Type
Experimental
Arm 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.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
OTAGO's exercises
Intervention Description
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
Intervention Name(s)
COMMON PRACTICE
Intervention Description
Normal medical treatment will be provided by family physicians and nurses.
Primary Outcome Measure Information:
Title
Reduction of falls measured with a questionnaire from April 2016 to June 2017.
Description
Evaluate the incidence of OTAGO's physical intervention program on fall reduction in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with a questionnaire at baseline and during follow-up.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Reduction of fracture measured with a questionnaire (location, causes and consequences) from April 2016 to June 2017.
Description
Evaluate the incidence of OTAGO's physical intervention program on fracture reduction in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with a questionnaire (location, causes and consequences) at baseline and during follow-up.
Time Frame
15 months
Title
Reduction of fear to fall measured with Falls Efficacy Scale (FES) from April 2016 to June 2017.
Description
Evaluate the incidence of OTAGO's physical intervention program on reduction of fear to fall in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with Falls Efficacy Scale (FES) at baseline and during follow-up.
Time Frame
15 months
Title
Parameters of physical frailty (strength) measured with switched test Timed Get Up and Go (TGUAG) from April 2016 to June 2017.
Description
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (strength) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with switched test Timed Get Up and Go (TGUAG) at baseline and during follow-up.
Time Frame
15 months
Title
Parameters of physical frailty (balance) measured through Biodex Balance System ('stability index') from April 2016 to June 2017.
Description
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (balance) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through Tinneti Scale and Biodex Balance System. Biodex Balance System provides valid, reliable and repeatable objective measures of a patient's ability to balance on stable and unstable surfaces. It provides visual biofeedback of a patient's ability to control their centre of gravity and their limits of stability. This test provides an objective 'stability index' that if higher than the predicted value indicates a strength, proprioception, and vestibular or visual impairment. Both monitoring at baseline and during follow-up.
Time Frame
15 months
Title
Parameters of physical frailty (motion) measured through "BTS G-WALK" from April 2016 to June 2017.
Description
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (flexibility) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through "BTS G-WALK". It is a wireless laptop, its software allows to analyze basic parameters of motion. It will be monitoring at baseline and during follow-up.
Time Frame
15 months
Title
Parameters of physical frailty (endurance) measured with dynamometer from April 2016 to June 2017.
Description
Evaluate the incidence of OTAGO's physical intervention program on improvement of parameters of physical frailty (endurance) in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be tested as strength measured with dynamometer in leg and arm. It will be monitoring at baseline and during follow-up.
Time Frame
15 months
Title
Appointment at the surgery measured through questionnaire of number of appointment in the practice
Description
Evaluate the incidence of OTAGO's physical intervention program on reduction of appointment in the practice of primary and second care and hospital admission in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through questionnaire of number of appointment in the practice in the previous year and during follow-up.
Time Frame
15 months
Title
Nursing Home admittance measured through questionnaire
Description
Evaluate the incidence of OTAGO's physical intervention program on reduction of inclusion rate in home care or institutionalization in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured through questionnaire of home care and/or institutionalization in the previous year and during follow-up.
Time Frame
15 months
Title
Drug reduction measured through questionnaire of kind of drug from April 2016 to June 2017.
Description
Evaluate the effect of drug reduction in the intervention of disprescription performed in the cohort by the usual care team in elderly (75-89 years). It will be measured through questionnaire of kind of drug, if there are any removed drug, and number and kind of drug removed to the end. Monitoring at baseline and during follow-up.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Azagra, PhD
Organizational Affiliation
Insitut Català de la Salut, Universitat Autònoma de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAP Barberà del Vallès
City
Barberà del Vallès
State/Province
Barcelona
ZIP/Postal Code
08210
Country
Spain
Facility Name
CAP Canaletes
City
Cerdanyola del Vallès
State/Province
Barcelona
ZIP/Postal Code
08290
Country
Spain
Facility Name
CAP Serraparera
City
Cerdanyola del Vallès
State/Province
Barcelona
ZIP/Postal Code
08290
Country
Spain
Facility Name
CAP Creu Alta
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
CAP Badia del Vallés
City
Barcelona
ZIP/Postal Code
08214
Country
Spain
Facility Name
CAP Castellar
City
Castellar del Vallès
ZIP/Postal Code
08211
Country
Spain
Facility Name
CAP La Llagosta
City
La Llagosta
ZIP/Postal Code
08120
Country
Spain
Facility Name
Cap Centre
City
Sabadell
ZIP/Postal Code
08201
Country
Spain
Facility Name
Cap Can Rull
City
Sabadell
ZIP/Postal Code
08206
Country
Spain
Facility Name
CAP Ca N'Oriach
City
Sabadell
ZIP/Postal Code
08207
Country
Spain
Facility Name
CAP Sud
City
Sabadell
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prevention of Falls and Its Consequences in Elderly People

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