Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05608941
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2022-10-27
Brief Title:
High-Intensity Respiratory Muscle Training in Individuals with Parkinsons Disease
Sponsor:
Federal University of Minas Gerais
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Effects of High-Intensity Respiratory Muscle Training on Respiratory Muscle Strength Functional Outcomes and Quality of Life in Individuals with Parkinsons Disease a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-09
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:
Background Individuals with PD commonly have a significant reduction in respiratory muscle strength and inspiratory muscle endurance and it can intensify with the disease progression Respiratory muscle training has shown to increase respiratory muscle strength in individuals with Parkinsons Disease PD However the effect size on other functional outcomes has not been determined andor investigated In addition no studies have investigated the effects of high-intensity respiratory muscle training inspiratory and expiratory in this population
Objectives The primary aim of this study will be to investigate the effects of high-intensity respiratory muscle training on inspiratory and expiratory muscle strength in individuals with PD The secondary aim of this study will be to investigate the efficacy of high-intensity respiratory muscle training in improving inspiratory muscle endurance peak cough flow dyspnea fatigue exercise capacity and quality of life in this population
Design A randomized controlled trial with blinded assessment will assign eligible participants to either high-intensity respiratory muscle training experimental group or sham training control group Individuals will perform a home-based intervention not directly supervised consisted of two daily 20-min sessions morning and afternoon seven times a week during eight weeks
Study Outcomes Primary outcomes are inspiratory and expiratory muscle strength MIP and MEP Secondary outcomes are respiratory muscle endurance peak cough flow dyspnea fatigue exercise capacity and quality of lifeThe outcomes will be measured at baseline post-intervention after the 8-week intervention and one month after the cessation of the intervention 12-week follow-up
Conclusion The results of this trial will provide valuable new information on the efficacy of high-intensity respiratory muscle training in improving muscle strength and other functional outcomes in individuals with PD
Objectives The primary aim of this study will be to investigate the effects of high-intensity respiratory muscle training on inspiratory and expiratory muscle strength in individuals with PD The secondary aim of this study will be to investigate the efficacy of high-intensity respiratory muscle training in improving inspiratory muscle endurance peak cough flow dyspnea fatigue exercise capacity and quality of life in this population
Design A randomized controlled trial with blinded assessment will assign eligible participants to either high-intensity respiratory muscle training experimental group or sham training control group Individuals will perform a home-based intervention not directly supervised consisted of two daily 20-min sessions morning and afternoon seven times a week during eight weeks
Study Outcomes Primary outcomes are inspiratory and expiratory muscle strength MIP and MEP Secondary outcomes are respiratory muscle endurance peak cough flow dyspnea fatigue exercise capacity and quality of lifeThe outcomes will be measured at baseline post-intervention after the 8-week intervention and one month after the cessation of the intervention 12-week follow-up
Conclusion The results of this trial will provide valuable new information on the efficacy of high-intensity respiratory muscle training in improving muscle strength and other functional outcomes in individuals with PD
Detailed Description:
Sample size calculation The sample size calculation was performed considering the primary outcome measures inspiratory and expiratory muscle strength The effect size for inspiratory muscle training was derived from a RCT with a similar population and intervention Considering a significance level α of 5 and a power of 080 thirteen participants per group are required a total of 26 participants The effect size for expiratory muscle training was also derived from a RCT with a similar population and intervention Considering a significance level α of 5 and a power of 080 fourteen participants per group are required a total of 28 participants Therefore a sample size of 28 individuals 14 in each group was defined largest sample size calculated Assuming an expected dropout rate of 20 a total sample size of 34 individuals was set 17 in each group
Statistical analyzes All statistical analyzes will be performed by an independent examiner blinded to the group allocation Each participant will assigned a unique code All analyzes will be performed using SPSS SPSS Inc Chicago IL USA The normality of data distribution will be for all continuous numeric variables Descriptive statistics will be calculated for all outcomesThe effects of the interventions will be analyzed from the collected data using intention-to-treat Data from the last available assessment will be used for missed sessions Two-way ANOVA with repeated measures 23 will be used to evaluate the differences between groups considering the time factor considering baseline post-intervention and 4-week follow-up for the variables inspiratory and expiratory muscle strength respiratory muscle endurance peak cough flow and exercise capacity The level of significance will be set at 5 and adjusted for multiple comparisons Data distribution and equality of variance will also be analyzed to ensure the parametric analysis has been applied correctly The effect sizes will be calculated to determine the magnitude of the differences between the groups The differences between the two mean values will be expressed in units of their SD expressed as Cohens d or mean results for the experimental group minus the mean results for the control group divided by the SD of the control group Effect sizes between 02 and 05 will be considered small between 05 and 08 medium and above 08 large
Statistical analyzes All statistical analyzes will be performed by an independent examiner blinded to the group allocation Each participant will assigned a unique code All analyzes will be performed using SPSS SPSS Inc Chicago IL USA The normality of data distribution will be for all continuous numeric variables Descriptive statistics will be calculated for all outcomesThe effects of the interventions will be analyzed from the collected data using intention-to-treat Data from the last available assessment will be used for missed sessions Two-way ANOVA with repeated measures 23 will be used to evaluate the differences between groups considering the time factor considering baseline post-intervention and 4-week follow-up for the variables inspiratory and expiratory muscle strength respiratory muscle endurance peak cough flow and exercise capacity The level of significance will be set at 5 and adjusted for multiple comparisons Data distribution and equality of variance will also be analyzed to ensure the parametric analysis has been applied correctly The effect sizes will be calculated to determine the magnitude of the differences between the groups The differences between the two mean values will be expressed in units of their SD expressed as Cohens d or mean results for the experimental group minus the mean results for the control group divided by the SD of the control group Effect sizes between 02 and 05 will be considered small between 05 and 08 medium and above 08 large
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