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Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study (Ros-Ita)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04711785
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera

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.


Condition or disease Intervention/treatment Phase
Frailty Geriatric Syndromes Functional Recovery Behavioral: Multicomponent exercise program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cohort study
Masking: None (Open Label)
Masking Description: Cohort study no masking presented.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Usual routine.



Primary Outcome Measures :
  1. Frailty reversion. [ Time Frame: Six months ]
    Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail

  2. Intrinsic capacity [ Time Frame: Six months ]
    ICOPE questionnaire score

  3. Quality of life objective and subjective [ Time Frame: Six months ]
    EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.

  4. Polypharmacy [ Time Frame: Six months ]
    Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.

  5. Cognitive state [ Time Frame: Six months ]
    Pfeiffer questionnaire

  6. Depression [ Time Frame: Six months ]
    Yesavage's Geriatrics Depression Scale (15 items)

  7. Nutrition state [ Time Frame: Six months ]
    Mini Nutritional Assessment Short Form. Score 0 to 14.

  8. Falls [ Time Frame: Six months ]
    Number of falls during follow-up period

  9. Sarcopenia [ Time Frame: Six months ]
    European Working Group on Sarcopenia in Older People (EWGSOP) criteria


Secondary Outcome Measures :
  1. Hospital admissions [ Time Frame: Six months ]
    Number of hospital admissions during follow-up period

  2. Visits to General Practitioner (GP) [ Time Frame: Six months ]
    Number of visits to GP during follow-up period

  3. Validation of a shaking measurement tool to asses muscle strength [ Time Frame: six months ]
    Gold standard Hand grip measured by dinamometry

  4. Validation of a gait speed mobile phone tool [ Time Frame: Six months ]
    Gold standard Gait speed measurement

  5. Validation of a pulmonar capacity mobile phone tool [ Time Frame: six months ]
    Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)



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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Francisco J. Tarazona Santabalbina, MD. PhD 617085442 fjtarazonas@gmail.com
Contact: José Viña, Professor 96 386 46 46 jvina@uv.es

Locations
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Spain
Hospital Universitario de la Ribera Recruiting
Alzira,, Kingdom Of Valéncia, Spain, 46660
Contact: Francisco J Tarazona-Santabalbina, MD,PhD    0034962458100 ext 8387    fjtarazona@hospital-ribera.com   
Sponsors and Collaborators
Hospital de la Ribera
University of Valencia
Investigators
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Principal Investigator: Francisco J Tarazona Santabalbina, MD, PhD Hospital Universitario de La Ribera
Publications of Results:
Other Publications:
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Responsible Party: Francisco Jose Tarazona-Santabalbina, MD, Ph D, Hospital de la Ribera
ClinicalTrials.gov Identifier: NCT04711785    
Other Study ID Numbers: HRibera001-12012021
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera:
older adults
frailty
geriatric assessment
geriatric syndromes
multicomponent exercise program
Additional relevant MeSH terms:
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Frailty
Pathologic Processes