Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362499
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Brief Title:
Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients
Sponsor:
Universidade Federal do Rio Grande do Norte
Organization:
Universidade Federal do Rio Grande do Norte
Study Overview
Official Title:
Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients Protocol for Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea fatigue chest pain and palpitations The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment
In many of these patients tachypnea at low levels of exertion suggests increased respiratory muscle activity which can lead to the sensation of dyspnea Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise In this way inspiratory muscle training can improve symptoms dysfunctional breathing possibly by attenuating the metaboreflex vagal modulation-attenuation of the sympathetic response of the inspiratory muscle in post-covid-19 subjects reducing ventilatory variability
In many of these patients tachypnea at low levels of exertion suggests increased respiratory muscle activity which can lead to the sensation of dyspnea Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise In this way inspiratory muscle training can improve symptoms dysfunctional breathing possibly by attenuating the metaboreflex vagal modulation-attenuation of the sympathetic response of the inspiratory muscle in post-covid-19 subjects reducing ventilatory variability
Detailed Description:
Primary objective To evaluate the effects of an unsupervised inspiratory muscle training IMT protocol on the behavior of ventilatory variability
Secondary objective Evaluate the effects of IMT on respiratory muscle strength pulmonary function quality of life peripheral muscle strength functional capacity and adverse effects and adherence
Material and methods Type of study and location of research This randomized controlled double-blind parallel two arm clinical trial will be conducted at the Laboratory of Health Assessment Measures LABMAS Department of Physiotherapy of the Federal University of Rio Grande do Norte UFRN
I The subjects included in the research will undergo three assessment stages pre-training Initial post-training 6 weeks Assessments in the pre-training period will be carried out in 1 day After recruitment participants will be invited to attend the UFRN Physiotherapy Department to carry out the first day of assessment by a previously trained evaluator blind to the intervention allocation group and will include anamnesis and physical examination with measurement of vital signs anthropometric measurements spirometry respiratory muscle strength manovacuometry functional capacity 6-minute step test and analysis of ventilatory variability portable ventilator assessment of peripheral muscle strength dynamometry quality of life SF-36
The sample will be automatically randomized through the website wwwrandomizationcom and allocated into two distinct groups Experimental Group GE inspiratory muscle training and Sham Group G2 IMT without load Three evaluators will participate in the research researcher 1 will be responsible only for the evaluations researcher 2 for respiratory muscle training with weekly load adjustment and researcher 3 for randomization The study will be double-blind as researcher 1 and participants will not be aware of the allocation of subjects into groups nor of the effects of the intervention
After the initial assessment all volunteers will receive a POWERbreathe classic light resistance device POWERbreathe Nsc Brazil to carry out the training and will be individually guided on how to use it and how to complete the protocol They will perform a trial session to familiarize themselves with the device that will not be considered for analysis Every week volunteers will receive a telephone call from researcher 2 who will not participate in the evaluation to confirm whether the exercise with the POWERbreathe will be performed appropriately at the recommended frequency intensity and duration and whether there are any questions regarding the protocol At the end of each week participants will receive a video call from researcher 2 to adjust the device according to G1s weekly load progression
Secondary objective Evaluate the effects of IMT on respiratory muscle strength pulmonary function quality of life peripheral muscle strength functional capacity and adverse effects and adherence
Material and methods Type of study and location of research This randomized controlled double-blind parallel two arm clinical trial will be conducted at the Laboratory of Health Assessment Measures LABMAS Department of Physiotherapy of the Federal University of Rio Grande do Norte UFRN
I The subjects included in the research will undergo three assessment stages pre-training Initial post-training 6 weeks Assessments in the pre-training period will be carried out in 1 day After recruitment participants will be invited to attend the UFRN Physiotherapy Department to carry out the first day of assessment by a previously trained evaluator blind to the intervention allocation group and will include anamnesis and physical examination with measurement of vital signs anthropometric measurements spirometry respiratory muscle strength manovacuometry functional capacity 6-minute step test and analysis of ventilatory variability portable ventilator assessment of peripheral muscle strength dynamometry quality of life SF-36
The sample will be automatically randomized through the website wwwrandomizationcom and allocated into two distinct groups Experimental Group GE inspiratory muscle training and Sham Group G2 IMT without load Three evaluators will participate in the research researcher 1 will be responsible only for the evaluations researcher 2 for respiratory muscle training with weekly load adjustment and researcher 3 for randomization The study will be double-blind as researcher 1 and participants will not be aware of the allocation of subjects into groups nor of the effects of the intervention
After the initial assessment all volunteers will receive a POWERbreathe classic light resistance device POWERbreathe Nsc Brazil to carry out the training and will be individually guided on how to use it and how to complete the protocol They will perform a trial session to familiarize themselves with the device that will not be considered for analysis Every week volunteers will receive a telephone call from researcher 2 who will not participate in the evaluation to confirm whether the exercise with the POWERbreathe will be performed appropriately at the recommended frequency intensity and duration and whether there are any questions regarding the protocol At the end of each week participants will receive a video call from researcher 2 to adjust the device according to G1s weekly load progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None