Back to resultsElderly Falls Prevention With sLiFE Program in Primary Care
Primary Purpose
Accidental Falls, Frailty, Elderly
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention Group
Control Group
Sponsored by
About this trial
This is an interventional prevention trial for Accidental Falls
Eligibility Criteria
Inclusion Criteria: People older than 65 years of age Living at home Speak and read Spanish Exclusion Criteria: 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 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
Sites / Locations
- Primary Care Research Unit of Salamanca (APISAL)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
The 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.
Participants will receive the usual health advice.
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 for 9 consecutive days
Physical activity
It will be evaluated with the Global Physical Activity Questionnaire
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.
Health effects
It will be measured using the quality of life questionnaire EQ-5D
Secondary Outcome Measures
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.
Cognitive assessment
It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.
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
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.
Full Information
NCT ID
NCT05912088
First Posted
June 11, 2023
Last Updated
October 16, 2023
Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
1. Study Identification
Unique Protocol Identification Number
NCT05912088
Brief Title
Elderly Falls Prevention With sLiFE Program in Primary Care
Official Title
Effectiveness of the sLiFE Program to Reduce Falls and Frailty in Elderly People in Primary Care. Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
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 daily activities carried out through group workshops (guided by a physiotherapist) and 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 sLiFE program is more effective than an usual health advice 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, Frailty, Elderly, Activities, Motor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
650 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants will receive the usual health advice.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
Subjects will participate in groups of about 14 to implement the program.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
Subjects will receive the usual care advice
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 for 9 consecutive days
Time Frame
8 days
Title
Physical activity
Description
It will be evaluated with the Global Physical Activity Questionnaire
Time Frame
6 months
Title
Frailty
Description
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.
Time Frame
6 months
Title
Health effects
Description
It will be measured using the quality of life questionnaire EQ-5D
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fear of falling
Description
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.
Time Frame
6 months
Title
Cognitive assessment
Description
It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.
Time Frame
6 months
Title
Motor function
Description
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
Time Frame
6 months
Title
Adherence to exercise
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
People older than 65 years of age
Living at home
Speak and read Spanish
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emiliano Rodríguez-Sánchez, Dr
Phone
923231859
Email
emiliano@usal.es
First Name & Middle Initial & Last Name or Official Title & Degree
Luis García-Ortiz, Dr
Phone
635542886
Email
lgarciao@usal.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis García-Ortiz, Dr
Organizational Affiliation
Primary Health Care Research Unit
Official's Role
Study Chair
Facility Information:
Facility Name
Primary Care Research Unit of Salamanca (APISAL)
City
Salamanca
ZIP/Postal Code
37005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Llamas, Dra
Phone
923 291100
Ext
54750
Email
inesllamas@usal.es
First Name & Middle Initial & Last Name & Degree
Emiliano Rodriguez, Dr
Phone
923 291100
Ext
54750
Email
Emiliano@usal.es
12. IPD Sharing Statement
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Elderly Falls Prevention With sLiFE Program in Primary Care
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