Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study

NCT ID: NCT04711785

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-01-31

Brief Summary

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The study has been designed to analyze the possible positive effects of a multicomponent physical exercise program monitored with an integrated electronic device system in dwelling-community frailty older adults.

The study will assess changes in physical, nutritional, cognitive, and psychological aspects after program finishes at six months.

Information will be collected by researchers at baseline, monthly and after study finishes.

Detailed Description

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The aging process is associated with physiological changes that determine a decrease in functional reserve and limit the ability to respond to external factors.

Likewise, aging is associated with a deterioration of the regulatory processes that maintain the functional integration of the different organs and systems. A direct consequence of this phenomenon is the atypical presentation of highly prevalent diseases in the elderly. This atypical presentation of diseases in the elderly is responsible for the so-called geriatric syndromes, considered as specific nosological entities with a high frequency of presentation in the elderly, being included within the prevention, diagnosis and treatment strategies of geriatric medicine.

These syndromes can generate greater morbidity and consequences, sometimes more serious than the disease that produces them. Its systematic detection should be included in the anamnesis of the clinical history of the elderly. Geriatric syndromes are a group of conditions usually caused by the conjunction of diseases with a high prevalence in the elderly and which are the frequent origin of functional or social disability in the population. They are the manifestation of many diseases, but they are also the beginning of many other problems that we must take into account from their detection to establish a good prevention of them.

The hypothesis of this work is that in frail and pre-frail older adults who participate in an integrated program of multicomponent physical exercise tutored by means of an app will improve their functional situation and reverse their diagnoses of pre and frailty.

Conditions

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Frailty Geriatric Syndromes Functional Recovery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Cohort study no masking presented.

Study Groups

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Intervention

Multicomponent exercise program twice a week (2 hours per week) during six months

Group Type ACTIVE_COMPARATOR

Multicomponent exercise program

Intervention Type BEHAVIORAL

The exposed group will carry out the following program of specific muscle strength and cardio physical activity aimed at reducing frailty.

For 2.5 hours per week.

Control Goup

Usual routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multicomponent exercise program

The exposed group will carry out the following program of specific muscle strength and cardio physical activity aimed at reducing frailty.

For 2.5 hours per week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Frailty
* Informed consent signature

Exclusion Criteria

* Life expectancy less than 6 months
* Acute Ischemic coronariopathy event during the last three months
* Active cancer treatment (chemoteraphy or radiotherapy) during the last three months
* Major surgery during the last six months
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role collaborator

Hospital de la Ribera

OTHER

Sponsor Role lead

Responsible Party

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Francisco Jose Tarazona-Santabalbina

MD, Ph D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco J Tarazona Santabalbina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de la Ribera

Locations

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Hospital Universitario de la Ribera

Alzira, Kingdom of Valéncia, Spain

Site Status

Countries

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Spain

References

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Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.

Reference Type BACKGROUND
PMID: 30419096 (View on PubMed)

Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27.

Reference Type BACKGROUND
PMID: 24291597 (View on PubMed)

Sanders LMJ, Hortobagyi T, la Bastide-van Gemert S, van der Zee EA, van Heuvelen MJG. Dose-response relationship between exercise and cognitive function in older adults with and without cognitive impairment: A systematic review and meta-analysis. PLoS One. 2019 Jan 10;14(1):e0210036. doi: 10.1371/journal.pone.0210036. eCollection 2019.

Reference Type BACKGROUND
PMID: 30629631 (View on PubMed)

Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.

Reference Type RESULT
PMID: 26947059 (View on PubMed)

Other Identifiers

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HRibera001-12012021

Identifier Type: -

Identifier Source: org_study_id

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