Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424743
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training
Sponsor:
Universidade Federal do Rio Grande do Norte
Organization:
Universidade Federal do Rio Grande do Norte
Study Overview
Official Title:
Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training Clinical Trial Randomized Crossover
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Fibromyalgia is a painful syndrome of unknown etiology which affects 2 of world population with symptoms such as pain unrefreshing sleep fatigue and mood disorders It is already established in the literature that resistance training is part of the non- pharmacological treatment for patients with fibromyalgia The big gap is about the quantity adequate andor recommended exercise volume despite some studies with exercise volumes different resistance trainings show improvements we do not have a direction besides We still do not know whether there is a preference for these patients in different resistance training volumes
Detailed Description:
Objective Assess training volume preference resisted in women with fibromyalgia
Method Crossover randomized clinical trial randomized and blind 36 women with fibromyalgia will be evaluated who will undergo three resistance training programs with different training volumes The primary outcome will be patient preference in relation to training volumes and the secondary ones will be the patient expectation pain intensity affect and subjective perception of exertion
Analysis statistics For the primary outcome preference the number of choices will be counted of the 3 types of training in percentage form Regarding the analysis of the primary outcome we will summarize the patients preference in a contingency table we will compare the proportions using the Chi-square test and finally we will check the effect size of the observed differences For secondary outcomes statistical analyzes will be performed by a blind statistician using commercial software The Kolmogorov-Smirnov test will be applied to verify the distribution of data and Levenes test will be used to analyze the homogeneity of variance The Bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times One 5 significance level and 95 CI will be adopted for all statistical analyses ethic and dissemination The results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings
Method Crossover randomized clinical trial randomized and blind 36 women with fibromyalgia will be evaluated who will undergo three resistance training programs with different training volumes The primary outcome will be patient preference in relation to training volumes and the secondary ones will be the patient expectation pain intensity affect and subjective perception of exertion
Analysis statistics For the primary outcome preference the number of choices will be counted of the 3 types of training in percentage form Regarding the analysis of the primary outcome we will summarize the patients preference in a contingency table we will compare the proportions using the Chi-square test and finally we will check the effect size of the observed differences For secondary outcomes statistical analyzes will be performed by a blind statistician using commercial software The Kolmogorov-Smirnov test will be applied to verify the distribution of data and Levenes test will be used to analyze the homogeneity of variance The Bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times One 5 significance level and 95 CI will be adopted for all statistical analyses ethic and dissemination The results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings
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