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

Sponsor

Hospital de la Ribera (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04711785

Collaborator

University of Valencia (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cohort studyCohort 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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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