Accidental FallsPRECIOSANCT02617303
Prevention of Falls and Its Consequences in Elderly People
A study testing OTAGO's exercises and COMMON PRACTICE in people with Accidental Falls and Osteoporosis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 11 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Osteoporosis
- What is being tested?
- OTAGO's exercises and COMMON PRACTICE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 11 sitesSpain
- Study dates
- Sep 2015to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
CAP Barberà del Vallès
Barbera Del Valles, Barcelona, 08210
CAP Badia del Vallés
Barcelona, 08214
CAP Castellar
Castellar del Vallès, 08211
CAP Canaletes
Cerdanyola del Vallès, Barcelona, 08290
CAP Serraparera
Cerdanyola del Vallès, Barcelona, 08290
CAP La Llagosta
La Llagosta, 08120
CAP Creu Alta
Sabadell, Barcelona, 08208
Cap Centre
Sabadell, 08201
Cap Can Rull
Sabadell, 08206
CAP Ca N'Oriach
Sabadell, 08207
CAP Sud
Sabadell
About this study
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
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.
Read the 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
- Being tested
- OTAGO's exercises, COMMON PRACTICE
- Keywords
- elderly, accidental falls, osteoporosis, fractures, Primary Care, Randomized clinical trial, Otago exercise programme
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTAGO's exercisesProcedure or surgery
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.
COMMON PRACTICEProcedure or surgery
Normal medical treatment will be provided by family physicians and nurses.
| Study group | Role | What they receive |
|---|---|---|
| OTAGO'S program arm | Experimental | 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. Receives: Procedure: OTAGO's exercises |
| CONTROL GROUP | Active comparator | 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. Receives: Procedure: COMMON PRACTICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (9)
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Azagra, PhD, Principal investigator, Insitut Català de la Salut, Universitat Autònoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617303
- Sponsor's protocol ID
- P14/099
- Acronym
- PRECIOSA
- Status last verified
- Oct 2020
- First submitted
- 11 Jun 2015
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02617303
- Acronym / sponsor ID
- PRECIOSA / P14/099
- Conditions
- Accidental Falls, Osteoporosis
- Keywords
- elderly, accidental falls, osteoporosis, fractures, Primary Care, Randomized clinical trial, Otago exercise programme
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTAGO'S program arm | Experimental | Procedure: OTAGO's exercisesPatients 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. |
| CONTROL GROUP | Active comparator | Procedure: COMMON PRACTICEPatients 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. |
Who may qualify
- Ages
- 75 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTAGO's exercisesThe 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. | Procedure or surgery | OTAGO'S program arm |
| COMMON PRACTICENormal medical treatment will be provided by family physicians and nurses. | Procedure or surgery | CONTROL GROUP |
Primary outcome
Reduction of falls measured with a questionnaire from April 2016 to June 2017.
Time frame: 15 months
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.
9 secondary outcomes
Reduction of fracture measured with a questionnaire (location, causes and consequences) from April 2016 to June 2017.
Time frame: 15 months
Reduction of fear to fall measured with Falls Efficacy Scale (FES) from April 2016 to June 2017.
Time frame: 15 months
Parameters of physical frailty (strength) measured with switched test Timed Get Up and Go (TGUAG) from April 2016 to June 2017.
Time frame: 15 months
Parameters of physical frailty (balance) measured through Biodex Balance System ('stability index') from April 2016 to June 2017.
Time frame: 15 months
Parameters of physical frailty (motion) measured through "BTS G-WALK" from April 2016 to June 2017.
Time frame: 15 months
Parameters of physical frailty (endurance) measured with dynamometer from April 2016 to June 2017.
Time frame: 15 months
Appointment at the surgery measured through questionnaire of number of appointment in the practice
Time frame: 15 months
Nursing Home admittance measured through questionnaire
Time frame: 15 months
Drug reduction measured through questionnaire of kind of drug from April 2016 to June 2017.
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Accidental Falls
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Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
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Evaluation of the PPAL
Age Problems
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Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
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The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Azagra, PhD principal investigator
Insitut Català de la Salut, Universitat Autònoma de Barcelona
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTAGO's exercises and COMMON PRACTICE in people with Accidental Falls and Osteoporosis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of falls measured with a questionnaire from April 2016 to June 2017. (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.