Multidimensional Intervention in Pre-frail Patients Older Than 70 Years

Multidimensional Intervention Directed to Pre-frail Patients Older Than 70 Years From Primary Care in a Basic Semi-urban Health Area

Aging represents a huge advance in society and a health and social challenge. Spain has one of the highest life expectancies in the world, but other countries with the same demographic characteristics are ahead of us in quality adjusted life years. Primary care setting has the main drivers of healthy aging, acting on the early stages of pre-frailty and frailty.

Therefore, it is proposed a multicomponent intervention (nutritional and prescription of physical exercise) in patients older than 70 years of the Medina del Campo Health Center, with pre-frailty criteria, in order to measure the changes that this intervention produces in their mild dysfunction and whether it is capable of reversing it or delaying the progression to a state of frailty.

Study Overview

• Status: Unknown
• Conditions: Frail Elderly Syndrome; Sarcopenia
• Intervention / Treatment: Behavioral: Intensive dietary advice and exercise prescription; Behavioral: Usual dietary advice and exercise prescription

Detailed Description

Hypothesis: A balanced diet, with a sufficient protein intake for each patient based on the Mediterranean diet, as well as the performance of multicomponent exercise 3 times a week, delays the evolution to stages of dysfunction or disability in the pre-frail population.

Objective:

• The main objective is to evaluate the effect of an intensive nutritional dietary treatment on the function markers in a sample of elderly people in a situation of pre-frailty.
• To Demonstrate the equivalence of the values obtained in terms of functional improvement through adequate exercise and diet in urban populations in a semi-urban population.
• To evaluate the change in analytical markers that indicate pre-frailty in patients under intensive dietary-nutritional treatment.
• To Study the improvement of quality of life in individuals with adequate nutrition and level of physical exercise in those over 70 years of age in pre-frailty stages, increasing the prevalence of healthy aging in our study population.

Methods:

- Design: This is a quasi-experimental study with a control group. Recruitment will be carried out, through random sampling, of patients over 70 years of age from the basic health area of Medina del Campo Urbano, detecting those who meet Fried's pre-frailty criteria, through the FRAIL questionnaire, being positive for pre-frailty fulfilling 1 or 2 criteria. These subjects detected as pre-frail will be randomly included in different multicomponent programs. In a group, two types of interventions will be carried out by the research team from primary care: Dietary advice adjusted to the needs of the patient and their pre-frailty stage, with an adequate nutritional and protein intake, based on the scientific evidence existing to date and in collaboration with the Clinical Hospital of Valladolid, Spain; and a multicomponent physical exercise prescription (elasticity, strength, resistance and balance), of at least 150 minutes per week, according to the WHO recommendations for this age group, adapting it individually, to be performed 3-5 times per week. Both branches of the intervention will be carried out through periodic interviews throughout a year of follow-up.

In the control group, the nutritional advice and prescription of regular physical exercise will be developed by the health team of the primary care center.

During this year, the parameters to be measured of functionality and independence, as well as anthropometric, quality of life and corresponding analytical parameters will be evaluated prior to the beginning of the intervention. Evaluating their variation at 3 months, 6 months and one year in both groups.

• Sample Size: It has been calculated to estimate a proportion similar to that of the population. Based on the prevalence of 50% existing in other study samples in the national territory for pre-frailty, and thus choosing the position of maximum indeterminacy (p = 50), assuming normality, for an α = 0.05 the Measure of the resulting sample calculated was 338 individuals.
• Chronogram:

Selection of patients: june 2019. Phone recruiting of patients: june 2019 Clinical and functional assessment will be carried out in Medina del Campo Health Center and randomization: july 2019-August 2019.

Intervention (First Time): October-december 2019; january-february 2020; july-august 2020; september-october 2020.

Follow up: Evaluation of parameters. July-August 2020; september-october 2020; november-december 2020; january-february 2021.

Statistycal Analysis: March-April 2021 Drafting of results: May-June 2021

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid
    • Medina del Campo, Valladolid, Spain, 47400
      • Recruiting
      • Cristina Gutiérrez-Lora
      • Contact: Cristina Gutiérrez-Lora, MD; Phone Number: 983812750; Email: cgulora@gmail.com
      • Contact: Cristina Gutiérrez-Lora, MD
      • Principal Investigator: Daniel A De Luis-Roman, MD; PhD
      • Principal Investigator: Juan J López-Gomez, MD; PhD
      • Principal Investigator: Cristina Gutiérrez-Lora, MD
      • Sub-Investigator: Pilar Nieto González
      • Sub-Investigator: Nuria Gracia Rodríguez
      • Sub-Investigator: Almudena Casas Manzanas
      • Sub-Investigator: Miguel A García Rodríguez, MD; PhD
      • Sub-Investigator: Ismael Calcerrada Alises
      • Sub-Investigator: Javier Gamarra Ortiz, MD
      • Sub-Investigator: María San Millán-González

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-institutionalized patients over 70 years of age from the basic health area of Medina del Campo Urbano, who meet pre-frailty criteria (1 or 2 Fried criteria).

Exclusion Criteria:

• Cognitive impairment
• Frailty syndrome
• Moderate-Severe Dependence
• Life Expectancy less than 6 months or patients in palliative care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive dietary advice and exercise prescription; Personalized dietary advice and exercise prescription according to nutritional status.	Behavioral: Intensive dietary advice and exercise prescription; Personalized dietary advice and exercise prescription according to nutritional status.; Other Names: Personalized dietary advice and exercise prescription
Active Comparator: Usual dietary advice and exercise prescription; Generalized dietary advice and exercise prescription in elder subjects.	Behavioral: Usual dietary advice and exercise prescription; Generalized dietary advice and excercise prescription in elder patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional assessment by Fried Criteria	Test of frail syndrome diagnosis in elder patients (Three out five criteria)	12 months
Fall Risk by test up and go	Functional tests of frail syndrome diagnosis in elder patients (<10 seconds: low fall risk; 10-20 seconds: fragility (risk of fall); >20 seconds: high risk of fall).	12 months
The Lawton Instrumental Activities of Daily Living (IADL) Scale	Functional tests of frail syndrome diagnosis in elder patients (Grade of depedence: <20: Total; 20-35: Severe; 40-55: Moderate; >60: Mild; 100: Independent).	12 months
Barthel Test for dependency	Functional tests of frail syndrome diagnosis in elder patients	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental Test	Cognitive evaluation (0-14: severe cognitive impairment; 15-19: moderate cognitive impairment; 20-24 mild cognitive impairment; 25-30: soft deficit of cognitive function; 30-35: normal).	12 months
Short Form 36 (SF-36) Health survey Questionnaire	Questionnaire to measure quality of life (0-100 --> 0=worst health status - 100=better health status).	12 months

Collaborators and Investigators

• Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain
• Investigators: Principal Investigator: Juan J LOPEZ-GOMEZ, MD; PhD, Hospital Clínico Universitario de Valladolid; Study Director: Daniel A De Luis Román, MD; PhD, University of Valladolid; Principal Investigator: Cristina Gutiérrez-Lora, MD, Primary Care Center (Medina del Campo (Valladolid, Spain))

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: PI 19-1425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No