Multidimensional Intervention in Pre-frail Patients Older Than 70 Years

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04574271
• Other study ID #: PI 19-1425
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: Endocrinology and Clinical Nutrition Research Center, Spain
• Contact: Juan J LOPEZ-GOMEZ, MD; PhD
• Phone: 983420000
• Email: jjlopez161282[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Sarcopenia

Intervention

Behavioral:
• Intensive dietary advice and exercise prescription
Personalized dietary advice and exercise prescription according to nutritional status.
• Usual dietary advice and exercise prescription
Generalized dietary advice and excercise prescription in elder patients.

Locations

Country	Name	City	State
Spain	Cristina Gutiérrez-Lora	Medina del Campo	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Endocrinology and Clinical Nutrition Research Center, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional assessment by Fried Criteria	Test of frail syndrome diagnosis in elder patients (Three out five criteria)	12 months
Primary	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
Primary	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
Primary	Barthel Test for dependency	Functional tests of frail syndrome diagnosis in elder patients	12 months
Secondary	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
Secondary	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