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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Frailty; Functional Recovery; Geriatric Syndromes
• Intervention / Treatment: Behavioral: Multicomponent exercise program

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Kingdom Of Valéncia
    • Alzira,, Kingdom Of Valéncia, Spain, 46660
      • Hospital Universitario de La Ribera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de la Ribera
• Collaborators: University of Valencia
• Investigators: Principal Investigator: Francisco J Tarazona Santabalbina, MD, PhD, Hospital Universitario de La Ribera

Publications and helpful links

General Publications

• Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869. Erratum In: JAMA Intern Med. 2019 Jan 1;179(1):127.
• Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27. Erratum In: Arch Phys Med Rehabil. 2018 Jan;99(1):211-212.
• Sanders LMJ, Hortobagyi T, la Bastide-van Gemert S, van der Zee EA, van Heuvelen MJG. Dose-response relationship between exercise and cognitive function in older adults with and without cognitive impairment: A systematic review and meta-analysis. PLoS One. 2019 Jan 10;14(1):e0210036. doi: 10.1371/journal.pone.0210036. eCollection 2019.
• Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: older adults; frailty; geriatric assessment; geriatric syndromes; multicomponent exercise program
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: HRibera001-12012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No