Clinical trial NCT04711785: Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study
Official title: Assessment of the Possible Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise Tutored at Home Through an Integrated Computer System. Cohort Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Frailty
Geriatric Syndromes
Functional Recovery
Keywords: older adults
frailty
geriatric assessment
geriatric syndromes
multicomponent exercise program
Lead sponsor: Hospital de la Ribera
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2021-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort study
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frailty reversion.
timeFrame: Six months
measure: Intrinsic capacity
timeFrame: Six months
measure: Quality of life objective and subjective
timeFrame: Six months
measure: Polypharmacy
timeFrame: Six months
measure: Cognitive state
timeFrame: Six months
measure: Depression
timeFrame: Six months
measure: Nutrition state
timeFrame: Six months
measure: Falls
timeFrame: Six months
measure: Sarcopenia
timeFrame: Six months
Secondary outcomes:
measure: Hospital admissions
timeFrame: Six months
measure: Visits to General Practitioner (GP)
timeFrame: Six months
measure: Validation of a shaking measurement tool to asses muscle strength
timeFrame: six months
measure: Validation of a gait speed mobile phone tool
timeFrame: Six months
measure: Validation of a pulmonar capacity mobile phone tool
timeFrame: six months
Other outcomes:
Locations:
city: Alzira,
country: Spain
facility: Hospital Universitario de la Ribera
state: Kingdom Of Valéncia
Study officials:
affiliation: Hospital Universitario de la Ribera
name: Francisco J Tarazona Santabalbina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.