NCT04559659

Brief Summary

The pourpose of this study is to verify if have relationship between respiratory muscle strenght, peripheral muscle blood flow and gait speed in the elderly.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 20, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

July 27, 2018

Last Update Submit

February 10, 2022

Conditions

Age Problem

Keywords

blood flow velocityagingrespiratory pressure

Outcome Measures

Primary Outcomes (1)

  • Peripheral muscle blood flow, gait speed and handgrip strength

    Check if there is a correlation between peripheral muscle blood flow, gait speed and handgrip strength and if this association is mediated by inspiratory muscle strength.

    Day 1

Interventions

Respiratory muscle strengthOTHER

Pimax and Pmax will be performed according to the (ATS) and (ERS). A Manovacuometer (Analog M 120, GlobalMed) with a range between 0-120cmH2O will be used. The elderly should undergo forced inspiration after maximal expiration and forced expiration after maximal inspiration through a mouthpiece with a hole to prevent closure of the glottis to evaluate Pimax and Pmax. The elderly should sustain the inspiration for 1 second. Three measurements will be performed, with a one-minute interval between them, with less difference equal to 10% between them, the higher value will be used.

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly of both sexes, over 65 years old, with and without inspiratory muscle weakness.

You may not qualify if:

  • Mini Mental Test \<24
  • Morse ≥ 51
  • Clinical instability, according to medical assessment • Structural heart disease, with ejection fraction \<50% and chronic lung diseases with FEV1 \<50% predicted,
  • Neurological, orthopedic, or neuromuscular diseases that prevent the performance of evaluations
  • Smokers or ex-smokers \<5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RIAE Vila Mariana

São Paulo, 0402040, Brazil

RECRUITING

Related Publications (12)

  • Cebria I Iranzo MD, Arnall DA, Igual Camacho C, Tomas JM, Melendez JC. Physiotherapy intervention for preventing the respiratory muscle deterioration in institutionalized older women with functional impairment. Arch Bronconeumol. 2013 Jan;49(1):1-9. doi: 10.1016/j.arbres.2012.07.007. Epub 2012 Sep 19. English, Spanish.

    PMID: 22999331BACKGROUND

  • Ribeiro JP, Chiappa GR, Callegaro CC. The contribution of inspiratory muscles function to exercise limitation in heart failure: pathophysiological mechanisms. Rev Bras Fisioter. 2012 Jul-Aug;16(4):261-7. doi: 10.1590/s1413-35552012005000034. Epub 2012 Jul 17. English, Portuguese.

    PMID: 22801449BACKGROUND

  • Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.

    PMID: 18436118BACKGROUND

  • Cosa D, Goncalves HA, Lima LP, Ike D, Cancelliero KM, Montebelo MI. New reference values for maximal respiratory pressures in the Brazilian population: corrections. J Bras Pneumol. 2010 Sep-Oct;36(5):667. doi: 10.1590/s1806-37132010000500021. No abstract available. English, Portuguese.

    PMID: 21085835BACKGROUND

  • Ritti-Dias RM, Cucato GG, de Mello Franco FG, Cendoroglo MS, Nasri F, Monteiro-Costa ML, de Carvalho JA, de Matos LD. Peak expiratory flow mediates the relationship between handgrip strength and timed up and go performance in elderly women, but not men. Clinics (Sao Paulo). 2016 Sep;71(9):517-20. doi: 10.6061/clinics/2016(09)06.

    PMID: 27652833BACKGROUND

  • Dumurgier J, Elbaz A, Ducimetiere P, Tavernier B, Alperovitch A, Tzourio C. Slow walking speed and cardiovascular death in well functioning older adults: prospective cohort study. BMJ. 2009 Nov 10;339:b4460. doi: 10.1136/bmj.b4460.

    PMID: 19903980BACKGROUND

  • Enright PL, Kronmal RA, Manolio TA, Schenker MB, Hyatt RE. Respiratory muscle strength in the elderly. Correlates and reference values. Cardiovascular Health Study Research Group. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):430-8. doi: 10.1164/ajrccm.149.2.8306041.

    PMID: 8306041BACKGROUND

  • Vaz Fragoso CA, Beavers DP, Hankinson JL, Flynn G, Berra K, Kritchevsky SB, Liu CK, McDermott MM, Manini TM, Rejeski WJ, Gill TM; Lifestyle Interventions Independence for Elders Study Investigators. Respiratory impairment and dyspnea and their associations with physical inactivity and mobility in sedentary community-dwelling older persons. J Am Geriatr Soc. 2014 Apr;62(4):622-8. doi: 10.1111/jgs.12738. Epub 2014 Mar 17.

    PMID: 24635756BACKGROUND

  • Fragoso CA, Gahbauer EA, Van Ness PH, Concato J, Gill TM. Peak expiratory flow as a predictor of subsequent disability and death in community-living older persons. J Am Geriatr Soc. 2008 Jun;56(6):1014-20. doi: 10.1111/j.1532-5415.2008.01687.x. Epub 2008 Apr 18.

    PMID: 18422951BACKGROUND

  • Harms CA, Babcock MA, McClaran SR, Pegelow DF, Nickele GA, Nelson WB, Dempsey JA. Respiratory muscle work compromises leg blood flow during maximal exercise. J Appl Physiol (1985). 1997 May;82(5):1573-83. doi: 10.1152/jappl.1997.82.5.1573.

    PMID: 9134907BACKGROUND

  • Higashi Y, Yoshizumi M. New methods to evaluate endothelial function: method for assessing endothelial function in humans using a strain-gauge plethysmography: nitric oxide-dependent and -independent vasodilation. J Pharmacol Sci. 2003 Dec;93(4):399-404. doi: 10.1254/jphs.93.399.

    PMID: 14737008BACKGROUND

  • Buchman AS, Boyle PA, Leurgans SE, Evans DA, Bennett DA. Pulmonary function, muscle strength, and incident mobility disability in elders. Proc Am Thorac Soc. 2009 Dec 1;6(7):581-7. doi: 10.1513/pats.200905-030RM.

    PMID: 19934353RESULT

Study Officials

  • Luciana D Janot, doctor

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana D Matos, doctor

CONTACT

(011) 2151-9408.luciana.matos@einstein.br

Letícia H Harada, specialist

CONTACT

(011) 2151-2189leticia.harada@einstein.br

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 27, 2018

First Posted

September 23, 2020

Study Start

August 20, 2019

Primary Completion

January 20, 2022

Study Completion

July 20, 2022

Last Updated

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)