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

Primary Purpose

Healthy Older Adults

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Inspiratory muscle fatigue
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Older Adults focused on measuring Inspiratory muscle fatigue, Functional mobility, Maximum Inspiratory Pressure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Railway General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMF arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Six minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
30sec sit to stand test
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.
Arm curl field test
The Arm Curl Fitness Test for upper body strength using the bicep curl technique, a test designed of the functional fitness of seniors
Stair climbing test
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

Secondary Outcome Measures

Physical activity scale for elderly (PASE)
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

Full Information

First Posted
March 31, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05812651
Brief Title
Effects of Induced Inspiratory Muscle Fatigue on Functional Mobility of Older Adults
Official Title
Effects of Induced Inspiratory Muscle Fatigue on Functional Mobility of Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Older Adults
Keywords
Inspiratory muscle fatigue, Functional mobility, Maximum Inspiratory Pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMF arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle fatigue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six minute walk test
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Time Frame
After 3 days
Title
30sec sit to stand test
Description
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.
Time Frame
After 3 days
Title
Arm curl field test
Description
The Arm Curl Fitness Test for upper body strength using the bicep curl technique, a test designed of the functional fitness of seniors
Time Frame
After 3 days
Title
Stair climbing test
Description
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
Time Frame
After 3 days
Secondary Outcome Measure Information:
Title
Physical activity scale for elderly (PASE)
Description
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
Time Frame
After 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Sheraz, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31662444
Citation
Seixas MB, Almeida LB, Trevizan PF, Martinez DG, Laterza MC, Vanderlei LCM, Silva LP. Effects of Inspiratory Muscle Training in Older Adults. Respir Care. 2020 Apr;65(4):535-544. doi: 10.4187/respcare.06945. Epub 2019 Oct 29.
Results Reference
background
PubMed Identifier
24749768
Citation
Giua R, Pedone C, Scarlata S, Carrozzo I, Rossi FF, Valiani V, Incalzi RA. Relationship between respiratory muscle strength and physical performance in elderly hospitalized patients. Rejuvenation Res. 2014 Aug;17(4):366-71. doi: 10.1089/rej.2014.1549.
Results Reference
background
PubMed Identifier
16814604
Citation
Watsford ML, Murphy AJ, Pine MJ. The effects of ageing on respiratory muscle function and performance in older adults. J Sci Med Sport. 2007 Feb;10(1):36-44. doi: 10.1016/j.jsams.2006.05.002. Epub 2006 Jun 30.
Results Reference
background
PubMed Identifier
31074198
Citation
Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076.
Results Reference
background

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

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