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

NCT04711785 | Withdrawn DMC

• 1 other identifier: HRibera001-12012021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Geriatric Syndromes; Functional Recovery

Keywords

older adults; frailty; geriatric assessment; geriatric syndromes; multicomponent exercise program

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Hospital admissions

  Six months

• Visits to General Practitioner (GP)

  Six months

• Validation of a shaking measurement tool to asses muscle strength

  six months

• Validation of a gait speed mobile phone tool

  Six months

• Validation of a pulmonar capacity mobile phone tool

  six months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Behavioral: Multicomponent exercise program

Control Goup

NO INTERVENTION

Usual routine.

Interventions

Multicomponent exercise program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Frailty
• Informed consent signature

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de la Ribera: lead
• University of Valencia: collaborator

Study Sites (1)

Hospital Universitario de la Ribera

Alzira, Kingdom of Valéncia, 46660, Spain

Location

Related Publications (4)

• 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.

  PMID: 30419096 BACKGROUND

• 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.

  PMID: 24291597 BACKGROUND

• 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.

  PMID: 30629631 BACKGROUND

• 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.

  PMID: 26947059 RESULT

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco J Tarazona Santabalbina, MD, PhD

  Hospital Universitario de la Ribera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Cohort study no masking presented.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph D

Model Details: Cohort study

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 15, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: January 31, 2024
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)