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Age ProblemNCT04559659

Relationship Between Respiratory Muscle Strenght, Peripheral Muscle Blood Flow and Gait Speed in the Elderly

An observational study of Age Problem, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Age Problem
What is being tested?
Respiratory muscle strength
How many people
50 participants
Where
1 siteBrazil
Study dates
20 Aug 2019to 20 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Luciana D Matos, doctor contact

(011) 2151-9408.

luciana.matos@einstein.br

Letícia H Harada, specialist contact

(011) 2151-2189

leticia.harada@einstein.br

Brazil1 site, 1 recruiting

  • RIAE Vila Mariana

    São Paulo, 0402040

    Luciana D Janot, doctor, 551121517202, lgjanot@gmail.com

    Letícia H Harada, specialist, 5511975917935, leticia.harada@einstein.br

    Recruiting

Other trials in Brazil

About this study

Official title: Study of the Relationship Between Respiratory Muscle Strenght, Peripheral Muscle Blood Flow and Gait Speed in the Elderly

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.

Read the detailed description

The hypothesis of this study is that elderly with inspiratory muscle weakness will present lower peripheral blood flow and consequently lower walking speed. The main aim of the study is to verify if the peripheral muscular blood flow in the elderly is different between patients with and without decrease in inspiratory muscle strength. As secondary objectives, it will be evaluated the correlation between inspiratory muscle strength and gait speed and quality of life, as well as gait speed and peripheral muscle blood flow. Fifty elderly patients of both sexes, over 65 years, from Vila Mariana Einstein Outpatient Clinic and Cora Residencial Senior, will be included to evaluate Maximum Inspiratory Pressure (Pimáx), Maximum Expiratory Pressure (Pemáx), Spirometry (FVC, PF, FEV1), 4.6m Walk Test, Quality of life for the elderly (WHOQOL old), Mini Mental Test, Body Mass Index (BMI) and peripheral muscle blood flow by venous occlusion plethysmography.

Conditions
Age Problem
Being tested
Respiratory muscle strength
Keywords
blood flow velocity, aging, respiratory pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start20 Aug 2019
  3. Primary completion20 Jan 2022
  4. Study completion20 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559659
Sponsor's protocol ID
3157-17
Status last verified
Feb 2022
First submitted
27 Jul 2018
Last updated
11 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22999331

  • 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.

    PubMed 22801449

  • 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.

    PubMed 18436118

  • 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.

    PubMed 21085835

  • 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.

    PubMed 27652833

  • 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.

    PubMed 19903980

  • 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.

    PubMed 8306041

  • 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.

    PubMed 24635756

  • 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.

    PubMed 18422951

  • 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.

    PubMed 9134907

  • 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.

    PubMed 14737008

  • 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.

    PubMed 19934353

Questions about this trial

What is this clinical trial studying?

An observational study of Age Problem, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luciana D Matos, doctor ((011) 2151-9408., luciana.matos@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral muscle blood flow, gait speed and handgrip strength (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559659, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.

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