NCT05812651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

March 31, 2023

Last Update Submit

July 7, 2023

Conditions

Keywords

Inspiratory muscle fatigueFunctional mobilityMaximum Inspiratory Pressure

Outcome Measures

Primary Outcomes (4)

  • Six minute walk test

    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

    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

    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

    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 Outcomes (1)

  • Physical activity scale for elderly (PASE)

    After 3 days

Study Arms (1)

IMF arm

EXPERIMENTAL

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.

Other: Inspiratory muscle fatigue

Interventions

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.

IMF arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 31662444BACKGROUND
  • 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.

    PMID: 24749768BACKGROUND
  • 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.

    PMID: 16814604BACKGROUND
  • 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.

    PMID: 31074198BACKGROUND

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

March 1, 2023

Primary Completion

May 30, 2023

Study Completion

July 1, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations