Healthy Older AdultsNCT05812651
Effects of Induced Inspiratory Muscle Fatigue on Functional Mobility of Older Adults
A study testing Inspiratory muscle fatigue in people with Healthy Older Adults, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults
- What is being tested?
- Inspiratory muscle fatigue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with age 60+ years
- Both male and female participants
- Patients with Forced Expiratory Volume 1/Forced Volume Capacity ratio greater than 80%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Older Adults
- Being tested
- Inspiratory muscle fatigue
- Keywords
- Inspiratory muscle fatigue, Functional mobility, Maximum Inspiratory Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle fatigueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Inspiratory muscle fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Measured: 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.
Measured: 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
Measured: 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
Measured: After 3 days
Secondary outcomes (1)
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
Measured: After 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Mar 2023
- Primary completion30 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy Older AdultsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812651
- Sponsor's protocol ID
- REC/01375 Qurat ul ain Gohar
- Status last verified
- Jul 2023
- First submitted
- 31 Mar 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31662444Giua 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.
PubMed 24749768Watsford 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.
PubMed 16814604Ferraro 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.
PubMed 31074198
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Induced Inspiratory Muscle Fatigue on Functional Mobility of Older Adults
- ClinicalTrials.gov ID
- NCT05812651
- Acronym / sponsor ID
- REC/01375 Qurat ul ain Gohar
- Conditions
- Healthy Older Adults
- Keywords
- Inspiratory muscle fatigue, Functional mobility, Maximum Inspiratory Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMF arm | Experimental | Other: Inspiratory muscle fatigueThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with age 60+ years
- Both male and female participants
- Patients with Forced Expiratory Volume 1/Forced Volume Capacity ratio greater than 80%
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle fatigueMuscle 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. | Other | IMF arm |
Primary outcome
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.
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.
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
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
1 secondary outcome
Physical activity scale for elderly (PASE)
Time frame: After 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Background: PubMed 31662444Seixas 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.
- Background: PubMed 24749768Giua 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.
- Background: PubMed 16814604Watsford 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.
- Background: PubMed 31074198Ferraro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle fatigue in people with Healthy Older Adults, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test (time frame: After 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05812651, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.