Effects of Induced Inspiratory Muscle Fatigue on Functional Mobility of Older Adults

July 7, 2023 updated by: Riphah International University
The aim of study was to evaluate the effects of inspiratory induced muscle fatigue on functional mobility of older adults. Though, limited literature exists regarding inspiratory muscle fatigue and its consequences on functional activities of daily living and balance. Yet, it is not clear how improvement in inspiratory muscle strength is related with improvement in functional mobility.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Respiratory muscle fatigue was first described in 1977. Inspiratory muscle relaxation rates are known to slow following induction of fatigue. Inspiratory muscle fatigue was induced by threshold loading at 80 percent of (Maximum Inspiratory Pressure) Pimax until the subjects were unable to generate the target pressure. Inspiratory muscle fatigue (IMF) is proposed to negotiation exercise performance, probably via a respiratory muscle metaboreflex that impairs blood flow to working muscles, thereby accelerating the progress of fatigue in these muscles. Respiratory muscle fatigue revealed that a maximal inspiratory load of 50% could quickly fatigue both the inspiration and expiration muscles. Increased inspiratory muscle work may induce fatigue of the respiratory muscles, as well as of the non-respiratory muscles by central alterations at spinal and supraspinal level. Also there is an association between respiratory muscle dysfunction and physical performance in older adults. The abnormalities of respiratory movements may be dependable clinical signs of inspiratory muscle fatigue, mostly when accompanied by tachypnea and hypercapnia. Fatigue is distinguished from weakness, a decrease in force generation that is static and not reversible by rest, though muscle weakness may be a susceptibility to muscle fatigue. This study will contribute to determine the effects of respiratory muscle fatigue on balance and functional mobility with healthy older adults. To further understand this relationship, a battery of tests (considered as gold standard) will be performed after induced inspiratory muscles fatigue.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

    • Punjab
      • Rawalpindi, Punjab, Pakistan
        • Railway General Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults with age 60+ years
  • Both male and female participants
  • Patients with Forced Expiratory Volume 1/Forced Volume Capacity ratio greater than 80%

Exclusion Criteria:

  • Smokers
  • Subjects with a history of cardiovascular, respiratory, or neuromuscular
  • Diseases that can impede test or alter the maximum inspiratory pressure.
  • Subjects with cognitive impairment.
  • Subjects with low back and musculoskeletal disorders.
  • Previous experience in respiratory muscle training.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMF arm

The interventional protocol will include healthy older adults age above 60 years. At baseline - all measurements will be collected. After 3 days to one week, as per feasibility, participants will come to the lab again and perform inspiratory Muscle training according to the protocol that tends to induce inspiratory muscle fatigue. (60-80%MIP).

Inspiratory resistive loading by starting at 60-80% (MIP) increasing every 10 minutes by 10% then measure Maximum Inspiratory Pressure (MIP), until MIP measurement decrease of more than 10% from baseline will be performed. When report a lower score of MIP and participants could no longer worked out, performed the functional mobility tests and see if there any variation. After the consent of participants an initial evaluation, Anthropometric measurements, Pulmonary function tests, PASE Questionnaire will be taken.

Muscle training according to the protocol that tends to induce inspiratory muscle fatigue. (60-80% MIP). Inspiratory resistive loading by starting at 60-80% (MIP) increasing every 10 minutes by 10% then measure MIP, until MIP measurement decrease of more than 10% from baseline will be performed.

When report a lower score of MIP and participants could no longer worked out, performed the functional mobility tests and see if there any variation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute walk test
Time Frame: After 3 days
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
After 3 days
30sec sit to stand test
Time Frame: After 3 days
The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults.
After 3 days
Arm curl field test
Time Frame: After 3 days
The Arm Curl Fitness Test for upper body strength using the bicep curl technique, a test designed of the functional fitness of seniors
After 3 days
Stair climbing test
Time Frame: After 3 days
The stair climb test (also known as stair climb power test) is a clinically relevant, safe, and inexpensive field-based assessment of lower body strength, power, and physical function for older adults
After 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity scale for elderly (PASE)
Time Frame: After 3 days
Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of persons age 65 years and older. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity
After 3 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Suman Sheraz, PhD*, Riphah International University

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.

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)

March 1, 2023

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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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