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

February 10, 2022 updated by: Luciana Diniz Nagem Janot Matos, Hospital Israelita Albert Einstein

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 0402040
        • Recruiting
        • RIAE Vila Mariana
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral muscle blood flow, gait speed and handgrip strength
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Luciana D Janot, doctor, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2019

Primary Completion (ACTUAL)

January 20, 2022

Study Completion (ANTICIPATED)

July 20, 2022

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

September 16, 2020

First Posted (ACTUAL)

September 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3157-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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