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Successful Aging and Frailty

Molecular and Functional Basis of Successful Aging and Frailty

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03963050
Acronym
SAFe
Enrollment
180
Registered
2019-05-24
Start date
2019-09-01
Completion date
2023-12-31
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Frailty Syndrome, Sarcopenia

Keywords

Frailty phenotype, Cognitive Impairment, Sarcopenia, Exercise

Brief summary

Frailty is the term commonly utilized to describe the geriatric syndrome that exposes the elderly to increased risk of negative health-related events. The frailty phenotypes (PF: physical or CF: cognitive) have demonstrated to predict the major negative health-related outcomes in the old population and show extensive similarities with sarcopenia (for PF) or dementia (for CF). However, the role of neurophysiological and biological factors contributing to the physical and cognitive frail condition, and in particular in which way mitochondrial dysfunction, as well as the hypertrophic and atrophic pathways assessed by genes expression, metabolomics and microbiota composition are contributing to these frail conditions, are still under debate. Therefore, the aim of this trial will be to make evidence based on the behaviors and the strategies that promote healthy lifestyle and successful human aging.

Detailed description

In the majority of the world, the population is living to a greater age. However, older age is usually associated with elevated risk of several pathologies, as well as age-related organ dysfunctions, which in turn can accelerate functional impairments, disability, or death. To identify this geriatric syndrome the term frailty phenotype has been commonly utilized. In particular, the frailty phenotype can be distinguished in physical frailty (PF) phenotype or cognitive frailty (CF) phenotype. Despite several groups of researchers tried to develop preventive interventions to counteract the physical and cognitive frail condition of elderly, the success of this task has been tempered by the lack of standardized, and universally agreed protocols. Moreover, the limited knowledge of the neurophysiological, and biological determinants of these conditions has precluded important advances in the research of this domain. Many factors combine to achieve a successful aging: genetics, health care and healty lifestile. Therefore, the aim of the current trial will be to understand the behaviors and the strategies that promote healthy lifestyle and successful human aging. Oldest old participants with CF and PF will be selected from the neurorehabilitation unit of the University Hospital of Verona (Italy). Healthy oldest old and young participants will be recruited from the section of Movement Sciences of the University of Verona. After a first phase of neurophysiological and biological examinations that will involve all the 4 groups, only CF and PF participants will be randomly assigned to an intervention program (physical exercise, physical+cognitive exercise or control). Frail participants assigned to exercise groups will then perform 1 year of intervention, 3 days per week, 1 hour per day. Afterwards, the three groups of intervention will undergo the same neurophysiological and biological examinations of the beginning of the study.

Interventions

OTHERExercise Training

The ET program will consist of endurance exercises at 70% of maximal Heart Rate and resistance exercises at 85% of 1 repetition maximum.

OTHERExercise Training + Cognitive Training

ET: The intervention program will consist of endurance exercises at 70% of maximal Heart Rate and resistance exercises at 85% of 1 repetition maximum. CT: The intervention program will be configured as a cognitive rehabilitation and mainly memory rehabilitation: the participants will be trained in practicing restorative and compensatory mnemonic techniques, such as visual imagery, face-name association, calendar, notes and prompts.

OTHERControl

NO changes in lifestyle

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
80 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* YH: 30 healthy young (20-25 years old) participants. They must be free of any disease. * OH: 30 healthy oldest old (80-90 years old) participants. They must be free of any neural or physical disease and any severe chronic disease (CODP, Heart Failure) that can compromise exercise. * PF: 30 oldest old (80-90 years old) participants. They must be characterized by functional deficits (sarcopenia, osteoporosis and muscle weakness) without cognitive impairment. Additionally, participants cannot be affected by any severe chronic disease that compromise exercise. * CF: 30 oldest old (80-90 years old) participants. They must be characterized by mild cognitive impairment (MCI) and subjective cognitive decline without functional deficits. Additionally, participants cannot be affected by any severe chronic disease that compromise exercise.

Exclusion criteria

YH * Any medication * Any disease * General: pregnancy, addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs, carrier of infectious diseases. * For TMS: Epilepsy, metallic prosthesis, malignant tumor

Design outcomes

Primary

MeasureTime frameDescription
Alveolar profiles3 yearsChanges in biogenic volatile organic compound concentrations can be used to mirror metabolic or pathophysiological processes in the whole body
Structural cerebral cortex adaptations (TMS)3 yearsSingle-pulse TMS will be used to map the brain area representing the vastus lateralis (VL).
Functional cerebral cortex adaptations (TMS)3 yearsSingle-pulse TMS will be used to investigate the excitability of the corticospinal system. A double-cone coil will be used to stimulate the leg area of the primary motor cortex (M1).
Modifications in the metabolism of cerebral areas (ASL-MRI)3 yearsTo assess non-invasively cerebral blood flow (CBF)
Muscle mass alterations (DXA)3 yearsMuscle mass will be assessed with DXA
Expression of potential biomarkers (circulating miRNA)3 yearsNoncoding RNAs, in particular, microRNAs (miRNAs), are a new regulatory system which plays a pivotal role in skeletal muscle adaptation and repairing.

Secondary

MeasureTime frameDescription
Changes in neuromuscular control 13 yearsThe force rate of development during a maximum voluntary contraction and a tetanic stimulation will be compared in order to estimate the role of central command flow to the muscle in changing the efficiency of the tension development at the tendon.
Changes in neuromuscular control 23 yearsThe EMG envelope rate of development during a maximum voluntary contraction and a tetanic stimulation will be compared in order to estimate the role of central command flow to the muscle in changing the efficiency of the tension development at the tendon.
Mitochondrial Respiration3 yearsChanges in mitochondrial respiration function will be measured to asses the level of mitochondrial dysfunction.
Changes in muscular fiber type3 yearsOutcome of the changes in fiber typing on the components of the muscle mechanics in each group and Pre-Post intervention in CF and PF groups will be evaluated.

Countries

Italy

Contacts

Primary ContactManuela Calderara
manuela.calderara@univr.it+39 0458124287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026