Accidental FallsNCT05070533
Interventions to Prevent Falls. PRECAISAL Study
A study testing Individual treatment and Groupal treatment in people with Accidental Falls and Old Age; Debility, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Old Age; Debility, Activity, Motor
- What is being tested?
- Individual treatment and Groupal treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2020to 28 May 2023
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older than 70 years
- Live at your address
- Are at risk of falls
- Timed Up and Go Test time timed ≥ 12 seconds
- Able to walk 200 meters without personal assistance
- Speak and read in Spanish
Who cannot join
- Perform moderate to vigorous physical activity> 150 min / week in the last 3 months
- Present any of the following medical conditions:
- Heart failure (New York Heart Association class III and IV)
- Recent stroke (<6 months)
- Parkinson's disease
- In active cancer treatment (last 6 months)
Show all 14Show fewer
- Class III and IV chronic obstructive pulmonary disease
- Unstable fracture of the lower limb
- Lower limb amputated
- Treatment for less than 6 months of depression
- Uncontrolled resting blood pressure of a systolic pressure> 160 or a diastolic pressure> 100 or more
- Not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of more than 2 months within the first 6 months of the study
- Moderate to severe cognitive impairment (Mini Mental cognitive assessment <23)
- Current participation in another scientific intervention trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study
This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.
Read the detailed description
Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.
The study tries to assess whether a group intervention following the principles of the LiFE program is no less effective than individual intervention in reducing the incidence of falls.
- Conditions
- Accidental Falls, Old Age; Debility, Activity, Motor
- Being tested
- Individual treatment, Groupal treatment
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual treatmentBehavioural
Participants will receive 7 home visits to implement the program.
Groupal treatmentBehavioural
Subjects will participate in groups of about 8 - 12 to implement the program.
| Study group | Role | What they receive |
|---|---|---|
| Individual treatment | Active comparator | The strength and balance activities of the LiFE program will be carried out. Participants will receive 7 home visits and will be given the support material for the manual (diptychs, pictures, etc.). Receives: Behavioral: Individual treatment |
| Groupal treatment | Experimental | The strength and balance activities of the LiFE program will be carried out. Participants will be invited to participate in groups of about 8 - 12 people in community venues. Receives: Behavioral: Groupal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of falls
Number of falls in relation to the degree of physical activity
Measured: 6 months
Physical activity
It will be evaluated with a digital pedometer
Measured: 9 days
Cost-effectiveness
Evaluated by the incremental cost-effectiveness ratio
Measured: 6 months
Health effects
They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5
Measured: 6 months
Secondary outcomes (2)
Fear of falling
It will be assessed using the Short Falls International Scale of Efficacy. This scale measures of "concerns about falling". This scale has 7 items with a Likert scale with 4 options: 1) not at all concerned, 2) somewhat concerned, 3) fairly concerned, and 4) very concerned.
Measured: 6 months
Adherence to exercise
It will be assessed using the Exercise Adherence Rating Scale (EARS). This scale is composed of 16 items and they were scored using a 5-point Likert scale (0 = completely agree to 4 = completely disagree) with a possible summed score range from 0 to 64.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start2 Jan 2020
- Primary completion1 Apr 2020
- Study completion28 May 2023
Why it stopped: Because of Covid19
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis García-Ortiz, Study chair, Primary Health Care Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070533
- Sponsor's protocol ID
- GRS 1985/B/19
- Status last verified
- Jun 2023
- First submitted
- 27 Sep 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study
- ClinicalTrials.gov ID
- NCT05070533
- Acronym / sponsor ID
- GRS 1985/B/19
- Conditions
- Accidental Falls, Old Age; Debility, Activity, Motor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of Covid19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 7 Oct 2021 (actual)
- 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.
This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.
Detailed description
Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.
The study tries to assess whether a group intervention following the principles of the LiFE program is no less effective than individual intervention in reducing the incidence of falls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual treatment | Active comparator | Behavioral: Individual treatmentThe strength and balance activities of the LiFE program will be carried out. Participants will receive 7 home visits and will be given the support material for the manual (diptychs, pictures, etc.). |
| Groupal treatment | Experimental | Behavioral: Groupal treatmentThe strength and balance activities of the LiFE program will be carried out. Participants will be invited to participate in groups of about 8 - 12 people in community venues. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Older than 70 years
- Live at your address
- Are at risk of falls
- Timed Up and Go Test time timed ≥ 12 seconds
- Able to walk 200 meters without personal assistance
Key exclusion criteria (14 listed)
- Perform moderate to vigorous physical activity> 150 min / week in the last 3 months
- Present any of the following medical conditions:
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 |
|---|---|---|
| Individual treatmentParticipants will receive 7 home visits to implement the program. | Behavioural | Individual treatment |
| Groupal treatmentSubjects will participate in groups of about 8 - 12 to implement the program. | Behavioural | Groupal treatment |
Primary outcome
Incidence of falls
Time frame: 6 months
Number of falls in relation to the degree of physical activity
Physical activity
Time frame: 9 days
It will be evaluated with a digital pedometer
Cost-effectiveness
Time frame: 6 months
Evaluated by the incremental cost-effectiveness ratio
Health effects
Time frame: 6 months
They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5
2 secondary outcomes
Fear of falling
Time frame: 6 months
Adherence to exercise
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Luis García-Ortiz study chair
Primary Health Care Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual treatment and Groupal treatment in people with Accidental Falls and Old Age; Debility, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site 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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of falls (time frame: 6 months). The study lists 4 primary outcomes in all. 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 13 Jun 2023.