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

Study Overview
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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.

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

Conditions
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Frailty, Geriatric Syndromes, Functional Recovery

Intervention / Treatment
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* Behavioral: Multicomponent exercise program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Multicomponent exercise program twice a week (2 hours per week) during six months | Behavioral: Multicomponent exercise program<br>* 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.<br>|
| No Intervention: Control Goup<br>Usual routine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty reversion. | Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail | Six months | 
| Intrinsic capacity | ICOPE questionnaire score | Six months | 
| Quality of life objective and subjective | EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10. | Six months | 
| Polypharmacy | Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs. | Six months | 
| Cognitive state | Pfeiffer questionnaire | Six months | 
| Depression | Yesavage's Geriatrics Depression Scale (15 items) | Six months | 
| Nutrition state | Mini Nutritional Assessment Short Form. Score 0 to 14. | Six months | 
| Falls | Number of falls during follow-up period | Six months | 
| Sarcopenia | European Working Group on Sarcopenia in Older People (EWGSOP) criteria | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admissions | Number of hospital admissions during follow-up period | Six months | 
| Visits to General Practitioner (GP) | Number of visits to GP during follow-up period | Six months | 
| Validation of a shaking measurement tool to asses muscle strength | Gold standard Hand grip measured by dinamometry | six months | 
| Validation of a gait speed mobile phone tool | Gold standard Gait speed measurement | Six months | 
| Validation of a pulmonar capacity mobile phone tool | Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC) | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older adults, frailty, geriatric assessment, geriatric syndromes, multicomponent exercise program