- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05812651
Effects of Induced Inspiratory Muscle Fatigue on Functional Mobility of Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan
- Railway General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Suman Sheraz, PhD*, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01375 Qurat ul ain Gohar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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