Multidimensional Intervention in Pre-frail Patients Older Than 70 Years

• ClinicalTrials.gov Identifier: NCT04574271
• Recruitment Status: Recruiting
• First Posted: October 5, 2020
• Last Update Posted: October 5, 2020
• Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain
• Information provided by (Responsible Party): Daniel de Luis Roman, Endocrinology and Clinical Nutrition Research Center, Spain

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Frail Elderly Syndrome; Sarcopenia	Behavioral: Intensive dietary advice and exercise prescription; Behavioral: Usual dietary advice and exercise prescription	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

• Intervention Group: Intensitve nutritional advice and exercise prescription adapted to physical performance.
• Control Group: Usual nutritional advice and exercise prescription.

• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Multidimensional Intervention Directed to Pre-frail Patients Older Than 70 Years From Primary Care in a Basic Semi-urban Health Area
• Actual Study Start Date: June 1, 2019
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Functional assessment by Fried Criteria [ Time Frame: 12 months ]
   Test of frail syndrome diagnosis in elder patients (Three out five criteria)
2. Fall Risk by test up and go [ Time Frame: 12 months ]
   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).
3. The Lawton Instrumental Activities of Daily Living (IADL) Scale [ Time Frame: 12 months ]
   Functional tests of frail syndrome diagnosis in elder patients (Grade of depedence: <20: Total; 20-35: Severe; 40-55: Moderate; >60: Mild; 100: Independent).
4. Barthel Test for dependency [ Time Frame: 12 months ]
   Functional tests of frail syndrome diagnosis in elder patients

Secondary Outcome Measures :

1. Mini-Mental Test [ Time Frame: 12 months ]
   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).
2. Short Form 36 (SF-36) Health survey Questionnaire [ Time Frame: 12 months ]
   Questionnaire to measure quality of life (0-100 --> 0=worst health status - 100=better health status).

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Juan J LOPEZ-GOMEZ, MD; PhD; 983420000 ext 86158; jjlopez161282@hotmail.com

Contact: Daniel A. De Luis Román, MD; PhD; 983420000 ext 86660; dadluis@yahoo.es

Locations

Spain

Cristina Gutiérrez-Lora; Recruiting

Medina del Campo, Valladolid, Spain, 47400

Contact: Cristina Gutiérrez-Lora, MD 983812750 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

Sponsors and Collaborators

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))

More Information

• Responsible Party: Daniel de Luis Roman, Professor, MD, PhD, Endocrinology and Clinical Nutrition Research Center, Spain
• ClinicalTrials.gov Identifier: NCT04574271
• Other Study ID Numbers: PI 19-1425
• First Posted: October 5, 2020
• Last Update Posted: October 5, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sarcopenia; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical