Multidimensional Intervention in Pre-frail Patients Older Than 70 Years

NCT04574271 | Completed DMC

• 1 other identifier: PI 19-1425
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome; Sarcopenia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Mini-Mental Test

  12 months

• Short Form 36 (SF-36) Health survey Questionnaire

  12 months

Study Arms (2)

Intensive dietary advice and exercise prescription

EXPERIMENTAL

Personalized dietary advice and exercise prescription according to nutritional status.

Behavioral: Intensive dietary advice and exercise prescription

Usual dietary advice and exercise prescription

ACTIVE COMPARATOR

Generalized dietary advice and exercise prescription in elder subjects.

Behavioral: Usual dietary advice and exercise prescription

Interventions

Intensive dietary advice and exercise prescription BEHAVIORAL

Personalized dietary advice and exercise prescription according to nutritional status.

Also known as: Personalized dietary advice and exercise prescription

Intensive dietary advice and exercise prescription

Usual dietary advice and exercise prescription BEHAVIORAL

Generalized dietary advice and excercise prescription in elder patients.

Usual dietary advice and exercise prescription

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Endocrinology and Clinical Nutrition Research Center, Spain: lead

Study Sites (1)

Cristina Gutiérrez-Lora

Medina del Campo, Valladolid, 47400, Spain

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Juan J LOPEZ-GOMEZ, MD; PhD

  Hospital Clínico Universitario de Valladolid

  PRINCIPAL INVESTIGATOR

• Daniel A De Luis Román, MD; PhD

  University of Valladolid

  STUDY DIRECTOR

• Cristina Gutiérrez-Lora, MD

  Primary Care Center (Medina del Campo (Valladolid, Spain))

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

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

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 5, 2020
• Study Start: June 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 19, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)