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

Frailty Clinical Trial

— Ros-Ita  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04711785
• Other study ID #: HRibera001-12012021
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2022
• Source: Hospital de la Ribera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2024
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Functional Recovery
• Geriatric Syndromes

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Ribera	Alzira,	Kingdom Of Valéncia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de la Ribera	University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Giné-Garriga M, Roqué-Fíguls M, Coll-Planas L, Sitjà-Rabert M, Salvà 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. Review. Erratum in: Arch Phys Med Rehabil. 2018 Jan;99(1):211-212. — View Citation

Martínez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Sáez de Asteasu ML, Lucia A, Galbete A, García-Baztán A, Alonso-Renedo J, González-Glaría B, Gonzalo-Lázaro M, Apezteguía Iráizoz I, Gutiérrez-Valencia M, Rodríguez-Mañas 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. — View Citation

Sanders LMJ, Hortobágyi 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. — View Citation

Tarazona-Santabalbina FJ, Gómez-Cabrera MC, Pérez-Ros P, Martínez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Mañas L, Viña J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Network — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty reversion.	Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail	Six months
Primary	Intrinsic capacity	ICOPE questionnaire score	Six months
Primary	Quality of life objective and subjective	EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.	Six months
Primary	Polypharmacy	Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.	Six months
Primary	Cognitive state	Pfeiffer questionnaire	Six months
Primary	Depression	Yesavage's Geriatrics Depression Scale (15 items)	Six months
Primary	Nutrition state	Mini Nutritional Assessment Short Form. Score 0 to 14.	Six months
Primary	Falls	Number of falls during follow-up period	Six months
Primary	Sarcopenia	European Working Group on Sarcopenia in Older People (EWGSOP) criteria	Six months
Secondary	Hospital admissions	Number of hospital admissions during follow-up period	Six months
Secondary	Visits to General Practitioner (GP)	Number of visits to GP during follow-up period	Six months
Secondary	Validation of a shaking measurement tool to asses muscle strength	Gold standard Hand grip measured by dinamometry	six months
Secondary	Validation of a gait speed mobile phone tool	Gold standard Gait speed measurement	Six months
Secondary	Validation of a pulmonar capacity mobile phone tool	Gold standard forced expiratory volume in 1 (FEV1) Forced vital capacity (FVC)	six months