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

Age Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559659
• Other study ID #: 3157-17
• Status: Recruiting
• Start date: August 20, 2019
• Est. completion date: July 20, 2022

Study information

• Verified date: February 2022
• Source: Hospital Israelita Albert Einstein
• Contact: Luciana D Matos, doctor
• Phone: (011) 2151-9408.
• Email: luciana.matos[@]einstein.br
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria: Elderly of both sexes, over 65 years old -

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Age Problem

Intervention

Other:
• Respiratory muscle strength
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.

Locations

Country	Name	City	State
Brazil	RIAE Vila Mariana	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

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. — View Citation

Cebrià I Iranzo MD, Arnall DA, Igual Camacho C, Tomás JM, Meléndez 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. — View Citation

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. — View Citation

Cosa D, Gonçalves 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. English, Portuguese. — View Citation

Dumurgier J, Elbaz A, Ducimetière P, Tavernier B, Alpérovitch 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2012 Jul 17. Review. English, Portuguese. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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