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Aging of the immune system, Frailty and physical exercise in the elderly

Imunosenescence, Frailty and physical exercise in the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9n5jbw
Enrollment
Unknown
Registered
2020-03-16
Start date
2021-03-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Frailty

Interventions

Intervention (66 participants: 22 frail
22 pré-frail and 22 robust): The Vivifrail exercise program consists of 5 possible exercise programs (Program A, Program B, Program C1, Program C2, Program D and Program E). The passports are exercis
seniors with a final score of 7 to 9 on the Short Physical Performance Battery and walking speed from 0.9 to 1.0 m/s will hold Program C
and the elderly with a final Short Physical Performance Battery score of 10 to 12 points and walking speed greater than 1.0 m/s will hold Program D. The exercises will start at light-moderate intensit
G11.427.410.698.277

Sponsors

Faculdade de Medicina de Jundiaí
Lead Sponsor

Eligibility

Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Age equal to or greater than 60 years; understand the instructions and guidelines about the study and freely agree to participate.

Exclusion criteria

Exclusion criteria: The exclusion criteria will be: probable cognitive impairment identified using the 10-point cognitive screening instrument (10-CS) with a final score of 0 to 5 points; any contra-indication for the VIVIFRAIL program (acute heart attack (recent 3-6 months) or unstable angina; uncontrolled atrial or ventricular arrhythmias; aortic dissecting aneurysm; severe aortic stenosis; acute endocarditis / pericarditis; uncontrolled high blood pressure (higher than 180/100 mmHg); acute thromboembolism; acute or severe heart failure; acute or severe respiratory failure; uncontrolled postural hypotension; uncontrolled acute decompensated diabetes mellitus or low blood sugar; a recent fracture in the last month (strength training); any other circumstance the doctors believes prevents doing physical activity, life-expectancy less than 12 months, permanent or temporary inability to walk; localized loss of strength and aphasia due to severe stroke; severe impairment of motor skills, speech or affectivity associated with Parkinson's disease in an advanced or unstable stage; severe hearing or vision deficits making communication very difficult; older adults who have cancer and autoimmune diseases in activity and follow-up; elderly people with cancer diagnosed in the last 3 years; inability to perform the Short Physical Performance Battery (SPPB) (score of zero); any limb amputation. Also, older patients who have performed physical activity or physical therapy in the 6 months preceding the start of the intervention will not be included.

Design outcomes

Primary

MeasureTime frame
A change in the inflammatory profile, whether a reduction in inflammatory mediators in serum (IL-6, TNF-alpha, IL1beta, IL-17, IL-22, and CXCL-8,) or culture supernatants (IL-6, TNF-alpha, IFN-gamma and IL-17) or an increased production of anti-inflammatory mediators (IL1RA and, IL-27) in serum or IL-10 and IL-4 in culture supernatants. We hypothesize that the intervention group would present an anti-inflammatory profile. This outcome will be assessed in the following moments: pre-intervention, post intervention (12 weeks) and 12 weeks after the end of the interventions

Secondary

MeasureTime frame
A change in physical performance according to the Short Physical Performance Battery Score (SPPB). We hypothesize that the intervention group would present at least a 1-point increase in the (Short Physical Performance Battery Score) SPPB. This outcome will be assessed in the following moments: pre-intervention, post intervention (12 weeks) and 12 weeks after the end of the interventions ;Maximal Isometric Force of Handgrip (kgf). We hypothesize that the intervention group would present an increase in the Maximal Isometric Force of Handgrip. This outcome will be assessed in the following moments: pre-intervention, post intervention (12 weeks) and 12 weeks after the end of the interventions. ;Gait speed (m/s). We hypothesize that the intervention group would present an increase in the gait speed. This outcome will be assessed in the following moments: pre-intervention, post intervention (12 weeks) and 12 weeks after the end of the interventions. ;Fatigue (questions 7 and 20 of the Center for Epidemiological Studies - Depression (CES-D) scale). We hypothesize that the intervention group would present a decrese the fatigue. This outcome will be assessed in the following moments: pre-intervention, post intervention (12 weeks) and 12 weeks after the end of the interventions.;Gait speed (m / s) during a dual-task (walking while the volunteer speaks animal names aloud). The intervention group is expected to show an increase in gait speed. This outcome will be assessed in the following moments: pre-intervention, post intervention (12 weeks) and 12 weeks after the end of the interventions.;Depression symptoms assessed using the Geriatric Depressive Scale (GDS). It is expected that the intervention group will decrease self-reported depression symptoms. This outcome will be assessed in the following moments: pre-intervention, post intervention (12 weeks) and 12 weeks after the end of the interventions.;Quality of life assessed using the score obtained on

Countries

Brazil

Contacts

Public ContactIvan Aprahamian

Faculdade de Medicina de Jundiaí

ivan.aprahamian@gmail.com+55-11-33952100

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 24, 2026