Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study (Ros-Ita)
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|ClinicalTrials.gov Identifier: NCT04711785|
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : August 25, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Frailty Geriatric Syndromes Functional Recovery||Behavioral: Multicomponent exercise program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cohort study|
|Masking:||None (Open Label)|
|Masking Description:||Cohort study no masking presented.|
|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|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||January 31, 2024|
Active Comparator: Intervention
Multicomponent exercise program twice a week (2 hours per week) during six months
Behavioral: Multicomponent exercise program
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.
No Intervention: Control Goup
- Frailty reversion. [ Time Frame: Six months ]Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail
- Intrinsic capacity [ Time Frame: Six months ]ICOPE questionnaire score
- Quality of life objective and subjective [ Time Frame: Six months ]EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.
- Polypharmacy [ Time Frame: Six months ]Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.
- Cognitive state [ Time Frame: Six months ]Pfeiffer questionnaire
- Depression [ Time Frame: Six months ]Yesavage's Geriatrics Depression Scale (15 items)
- Nutrition state [ Time Frame: Six months ]Mini Nutritional Assessment Short Form. Score 0 to 14.
- Falls [ Time Frame: Six months ]Number of falls during follow-up period
- Sarcopenia [ Time Frame: Six months ]European Working Group on Sarcopenia in Older People (EWGSOP) criteria
- Hospital admissions [ Time Frame: Six months ]Number of hospital admissions during follow-up period
- Visits to General Practitioner (GP) [ Time Frame: Six months ]Number of visits to GP during follow-up period
- Validation of a shaking measurement tool to asses muscle strength [ Time Frame: six months ]Gold standard Hand grip measured by dinamometry
- Validation of a gait speed mobile phone tool [ Time Frame: Six months ]Gold standard Gait speed measurement
- Validation of a pulmonar capacity mobile phone tool [ Time Frame: six months ]Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711785
|Contact: Francisco J. Tarazona Santabalbina, MD. PhDfirstname.lastname@example.org|
|Contact: José Viña, Professor||96 386 46 email@example.com|
|Hospital Universitario de la Ribera||Recruiting|
|Alzira,, Kingdom Of Valéncia, Spain, 46660|
|Contact: Francisco J Tarazona-Santabalbina, MD,PhD 0034962458100 ext 8387 firstname.lastname@example.org|
|Principal Investigator:||Francisco J Tarazona Santabalbina, MD, PhD||Hospital Universitario de La Ribera|