Clinical trial NCT06424743: Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training
Official title: Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia, Primary
Chronic Pain
Exercise Addiction
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be allocated to 1 of three groups: 1 set, 2 sets, or 3 sets of resistance exercise. In the next sessions they will be allocated to the series he has not performed yet.
Primary purpose: TREATMENT

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 and/or 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 patient's 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 Levene's 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.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 to 65
* Have a diagnosis of fibromyalgia according to the ACR 2016 criteria

Exclusion Criteria:

* Have performed resistance training in the last 6 months
* Having another associated rheumatic condition
* Have a trip or appointment scheduled that requires absence for the next 4 (four) weeks from the start of the survey;
* Women with musculoskeletal injuries in the upper and/or lower limbs
* Have heart problems that prevent maximal efforts and submaximums

Primary outcomes:
measure: Choose one of the workouts according to your preference
timeFrame: 28 day
Secondary outcomes:
measure: Change in Expectation
timeFrame: baseline
measure: Change in Pain intensity
timeFrame: baseline, 28 day
measure: Change in Affection
timeFrame: baseline, 28 day
measure: Change in Subjective perception of exertion
timeFrame: baseline, 28 day
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Marcelo Cardoso de Souza
state: RN
Study officials:
References:
citation: Silva HJA, Assuncao Junior JC, de Oliveira FS, Oliveira JMP, Figueiredo Dantas GA, Lins CAA, de Souza MC. Sophrology versus resistance training for treatment of women with fibromyalgia: A randomized controlled trial. J Bodyw Mov Ther. 2019 Apr;23(2):382-389. doi: 10.1016/j.jbmt.2018.02.005. Epub 2018 Feb 12.