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Interventions to Prevent Falls. PRECAISAL Study

Primary Purpose

Accidental Falls, Old Age; Debility, Activity, Motor

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Individual treatment
Groupal treatment
Sponsored by
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Accidental Falls

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
    • 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.

Sites / Locations

  • Infosalud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Individual treatment

Groupal treatment

Arm Description

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.).

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.

Outcomes

Primary Outcome Measures

Incidence of falls
Number of falls in relation to the degree of physical activity
Physical activity
It will be evaluated with a digital pedometer
Cost-effectiveness
Evaluated by the incremental cost-effectiveness ratio
Health effects
They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 27, 2021
Last Updated
June 11, 2023
Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
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1. Study Identification

Unique Protocol Identification Number
NCT05070533
Brief Title
Interventions to Prevent Falls. PRECAISAL Study
Official Title
Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Because of Covid19
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Old Age; Debility, Activity, Motor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual treatment
Arm Type
Active Comparator
Arm Description
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.).
Arm Title
Groupal treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual treatment
Intervention Description
Participants will receive 7 home visits to implement the program.
Intervention Type
Behavioral
Intervention Name(s)
Groupal treatment
Intervention Description
Subjects will participate in groups of about 8 - 12 to implement the program.
Primary Outcome Measure Information:
Title
Incidence of falls
Description
Number of falls in relation to the degree of physical activity
Time Frame
6 months
Title
Physical activity
Description
It will be evaluated with a digital pedometer
Time Frame
9 days
Title
Cost-effectiveness
Description
Evaluated by the incremental cost-effectiveness ratio
Time Frame
6 months
Title
Health effects
Description
They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fear of falling
Description
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.
Time Frame
6 months
Title
Adherence to exercise
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis García-Ortiz
Organizational Affiliation
Primary Health Care Research Unit
Official's Role
Study Chair
Facility Information:
Facility Name
Infosalud
City
Salamanca
ZIP/Postal Code
37005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Interventions to Prevent Falls. PRECAISAL Study

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