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Accidental FallsNCT05912088

Elderly Falls Prevention With sLiFE Program in Primary Care

A study testing Intervention Group in people with Accidental Falls and Frailty, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 daily activities carried out through group workshops (guided by a physiotherapist) and at preventing risk situations at home. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Accidental Falls, Frailty, Elderly
What is being tested?
Intervention Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
1 siteSpain
Study dates
1 Mar 2023to 31 Jul 2025
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • People older than 65 years of age
  • Living at home
  • Speak and read Spanish

Who cannot join

  • Heart failure (NYHA class III and IV)
  • Recent stroke (<6 months)
  • Parkinson's disease
  • In active cancer treatment (last 6 months)
  • GOLD class III and IV chronic obstructive pulmonary disease
  • Unstable lower extremity fracture
Show all 12Show fewer
  • Amputated lower extremity
  • Treatment less than 6 months of depression
  • Uncontrolled resting blood pressure of a systolic > 160 or diastolic > 100 or more
  • Unavailability for intervention, planned travel or relocation 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 interventional clinical trial

Trial locations and contacts

1 site in 1 country.

Emiliano Rodríguez-Sánchez, Dr contact

923231859

emiliano@usal.es

Luis García-Ortiz, Dr contact

635542886

lgarciao@usal.es

Spain1 site, 1 recruiting

  • Primary Care Research Unit of Salamanca (APISAL)

    Salamanca, 37005

    Ines Llamas, Dra, 923 291100 ext. 54750, inesllamas@usal.es

    Emiliano Rodriguez, Dr, 923 291100 ext. 54750, Emiliano@usal.es

    Recruiting

Other trials in Spain

About this study

Official title: Effectiveness of the sLiFE Program to Reduce Falls and Frailty in Elderly People in Primary Care. Randomized Clinical Trial

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 daily activities carried out through group workshops (guided by a physiotherapist) and 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 sLiFE program is more effective than an usual health advice reducing the incidence of falls.

Being tested
Intervention Group, Control Group
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.

  • Intervention GroupBehavioural

    Subjects will participate in groups of about 14 to implement the program.

  • Control GroupBehavioural

    Subjects will receive the usual care advice

Study groups in NCT05912088
Study groupRoleWhat they receive
Intervention GroupExperimentalThe strength and balance activities of the sLiFE program will be carried out. Participants will be invited to participate in groups of about 14 people in Primary Care Heath Centers.
Receives: Behavioral: Intervention Group
Control GroupPlacebo comparatorParticipants will receive the usual health advice.
Receives: Behavioral: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of falls

    Number of falls in relation to the degree of physical activity.

    Measured: 6 months

  2. Physical activity

    It will be evaluated with a digital pedometer for 9 consecutive days

    Measured: 8 days

  3. Physical activity

    It will be evaluated with the Global Physical Activity Questionnaire

    Measured: 6 months

  4. Frailty

    Frailty will be measured according to the five criteria of Fried's phenotype: 1) Low muscle strength; 2) Poor nutrition; 3) Poor endurance; 4) Slow walking and 5) Low physical activity.

    Measured: 6 months

  5. Health effects

    It will be measured using the quality of life questionnaire EQ-5D

    Measured: 6 months

Secondary outcomes (4)

  1. Fear of falling

    It will be assesses using the Short Falls International Scale of Efficacy (Short FES I). It 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

  2. Cognitive assessment

    It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.

    Measured: 6 months

  3. Motor function

    It will be evaluated with the Short Physical Performance Battery (SPPB). It assesses three aspects of mobility: balance, gait speed and strength of limbs or lower limbs to get up from a chair

    Measured: 6 months

  4. Adherence to exercise

    It will be assessed using the Exercise Adherence Rating Scale (EARS). It is composed of 16 items 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.

  1. First posted22 Jun 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

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
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912088
Sponsor's protocol ID
GRS 2502/B/22
Status last verified
Jun 2023
First submitted
11 Jun 2023
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Llamas-Ramos I, Llamas-Ramos R, Lugones-Sanchez C, Gonzalez-Garcia S, Tamayo-Morales O, Alvarado-Omenat JJ, Pablos-Hernandez C, Gomez-Marcos MA, Garcia-Ortiz L, Rodriguez-Sanchez E. Effect of a lifestyle-integrated functional exercise (LiFE) group intervention (sLiFE) to falls prevention in non-institutionalized older adults. Protocol of a randomised clinical trial. Front Public Health. 2024 Jan 8;11:1304982. doi: 10.3389/fpubh.2023.1304982. eCollection 2023.

    PubMed 38259747

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Accidental Falls and Frailty, 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 3 inclusion and 12 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 18 Oct 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. Some participants in this study may receive a placebo. 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?

Contact Emiliano Rodríguez-Sánchez, Dr (923231859, emiliano@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of falls (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05912088, which also lists 1 linked publication.

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 18 Oct 2023.

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