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

Assessment of the Possible Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise Tutored at Home Through an Integrated Computer System. Cohort Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04711785
Acronym
Ros-Ita
Enrollment
0
Registered
2021-01-15
Start date
2021-09-01
Completion date
2024-01-31
Last updated
2022-07-21

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

Conditions

Functional Recovery, Frailty, Geriatric Syndromes

Keywords

older adults, frailty, geriatric assessment, geriatric syndromes, multicomponent exercise program

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.

Interventions

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.

Sponsors

University of Valencia
CollaboratorOTHER
Hospital de la Ribera
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Cohort study no masking presented.

Intervention model description

Cohort study

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
SarcopeniaSix monthsEuropean Working Group on Sarcopenia in Older People (EWGSOP) criteria
PolypharmacySix monthsQuantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.
Cognitive stateSix monthsPfeiffer questionnaire
DepressionSix monthsYesavage's Geriatrics Depression Scale (15 items)
Nutrition stateSix monthsMini Nutritional Assessment Short Form. Score 0 to 14.
FallsSix monthsNumber of falls during follow-up period
Frailty reversion.Six monthsLinda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail
Intrinsic capacitySix monthsICOPE questionnaire score
Quality of life objective and subjectiveSix monthsEuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.

Secondary

MeasureTime frameDescription
Visits to General Practitioner (GP)Six monthsNumber of visits to GP during follow-up period
Validation of a shaking measurement tool to asses muscle strengthsix monthsGold standard Hand grip measured by dinamometry
Validation of a gait speed mobile phone toolSix monthsGold standard Gait speed measurement
Validation of a pulmonar capacity mobile phone toolsix monthsGold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)
Hospital admissionsSix monthsNumber of hospital admissions during follow-up period

Countries

Spain

Outcome results

None listed

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