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

Not Applicable

Withdrawn

• Conditions: Geriatric Syndromes; Functional Recovery; Frailty
• Interventions: Behavioral: Multicomponent exercise program

• Registration Number: NCT04711785
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-09-01
• Primary Completion: 2021-09-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Multicomponent exercise program	Multicomponent exercise program twice a week (2 hours per week) during six months

Primary Outcome Measures

Name	Time	Method
Intrinsic capacity	Six months	ICOPE questionnaire score
Frailty reversion.	Six months	Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail
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
Nutrition state	Six months	Mini Nutritional Assessment Short Form. Score 0 to 14.
Falls	Six months	Number of falls during follow-up period
Depression	Six months	Yesavage's Geriatrics Depression Scale (15 items)
Sarcopenia	Six months	European Working Group on Sarcopenia in Older People (EWGSOP) criteria

Secondary Outcome Measures

Name	Time	Method
Validation of a gait speed mobile phone tool	Six months	Gold standard Gait speed measurement
Validation of a shaking measurement tool to asses muscle strength	six months	Gold standard Hand grip measured by dinamometry
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 pulmonar capacity mobile phone tool	six months	Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)

Trial Locations

Locations (1)

Hospital Universitario de la Ribera; 🇪🇸 Alzira,, Kingdom Of Valéncia, Spain