Frail Elderly SyndromeNCT04574271
Multidimensional Intervention in Pre-frail Patients Older Than 70 Years
A study testing Intensive dietary advice and exercise prescription and Usual dietary advice and exercise prescription in people with Frail Elderly Syndrome and Sarcopenia, run by Endocrinology and Clinical Nutrition Research Center, Spain at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Sarcopenia
- What is being tested?
- Intensive dietary advice and exercise prescription and Usual dietary advice and exercise prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- Cognitive impairment
- Frailty syndrome
- Moderate-Severe Dependence
- Life Expectancy less than 6 months or patients in palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Frail Elderly Syndrome, Sarcopenia
- Being tested
- Intensive dietary advice and exercise prescription, Usual dietary advice and exercise prescription
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive dietary advice and exercise prescriptionBehavioural
Also called Personalized dietary advice and exercise prescription
Personalized dietary advice and exercise prescription according to nutritional status.
Usual dietary advice and exercise prescriptionBehavioural
Generalized dietary advice and excercise prescription in elder patients.
| Study group | Role | What they receive |
|---|---|---|
| Intensive dietary advice and exercise prescription | Experimental | Personalized dietary advice and exercise prescription according to nutritional status. Receives: Behavioral: Intensive dietary advice and exercise prescription |
| Usual dietary advice and exercise prescription | Active comparator | Generalized dietary advice and exercise prescription in elder subjects. Receives: Behavioral: Usual dietary advice and exercise prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional assessment by Fried Criteria
Test of frail syndrome diagnosis in elder patients (Three out five criteria)
Measured: 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).
Measured: 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).
Measured: 12 months
Barthel Test for dependency
Functional tests of frail syndrome diagnosis in elder patients
Measured: 12 months
Secondary outcomes (2)
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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jun 2019
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocrinology and Clinical Nutrition Research Center, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel de Luis Roman, Endocrinology and Clinical Nutrition Research Center, Spain
- Investigators
- Juan J LOPEZ-GOMEZ, MD; PhD, Principal investigator, Hospital Clínico Universitario de ValladolidDaniel A De Luis Román, MD; PhD, Study director, University of ValladolidCristina Gutiérrez-Lora, MD, Principal investigator, Primary Care Center (Medina del Campo (Valladolid, Spain))
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574271
- Sponsor's protocol ID
- PI 19-1425
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Intervention Directed to Pre-frail Patients Older Than 70 Years from Primary Care in a Basic Semi-urban Health Area
- ClinicalTrials.gov ID
- NCT04574271
- Acronym / sponsor ID
- PI 19-1425
- Conditions
- Frail Elderly Syndrome, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Endocrinology and Clinical Nutrition Research Center, SpainUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Intervention Group: Intensitve nutritional advice and exercise prescription adapted to physical performance. * Control Group: Usual nutritional advice and exercise prescription.
| Arm | Type | Receives |
|---|---|---|
| Intensive dietary advice and exercise prescription | Experimental | Behavioral: Intensive dietary advice and exercise prescriptionPersonalized dietary advice and exercise prescription according to nutritional status. |
| Usual dietary advice and exercise prescription | Active comparator | Behavioral: Usual dietary advice and exercise prescriptionGeneralized dietary advice and exercise prescription in elder subjects. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- Cognitive impairment
- Frailty syndrome
- Moderate-Severe Dependence
- Life Expectancy less than 6 months or patients in palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive dietary advice and exercise prescriptionAlso: Personalized dietary advice and exercise prescriptionPersonalized dietary advice and exercise prescription according to nutritional status. | Behavioural | Intensive dietary advice and exercise prescription |
| Usual dietary advice and exercise prescriptionGeneralized dietary advice and excercise prescription in elder patients. | Behavioural | Usual dietary advice and exercise prescription |
Primary outcome
Functional assessment by Fried Criteria
Time frame: 12 months
Test of frail syndrome diagnosis in elder patients (Three out five criteria)
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).
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).
Barthel Test for dependency
Time frame: 12 months
Functional tests of frail syndrome diagnosis in elder patients
2 secondary outcomes
Mini-Mental Test
Time frame: 12 months
Short Form 36 (SF-36) Health survey Questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan J LOPEZ-GOMEZ, MD; PhD principal investigator
Hospital Clínico Universitario de Valladolid
Daniel A De Luis Román, MD; PhD study director
University of Valladolid
Cristina Gutiérrez-Lora, MD principal investigator
Primary Care Center (Medina del Campo (Valladolid, Spain))
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive dietary advice and exercise prescription and Usual dietary advice and exercise prescription in people with Frail Elderly Syndrome and Sarcopenia, run by Endocrinology and Clinical Nutrition Research Center, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional assessment by Fried Criteria (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.