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Recruiting NCT06424743

Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training

No phase Interventional Fibromyalgia, Primary Chronic Pain Exercise Addiction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exercise.
Who it may be relevant to
Registry conditions: Fibromyalgia, Primary, Chronic Pain, Exercise Addiction. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover

Overview

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.

Interventions

  • Other exercise
    exercise programs with different volumes

Primary outcome measures

  • Choose one of the workouts according to your preference [Time frame: 28 day]
Secondary outcome measures (4)
  • Change in Expectation [Time frame: baseline]
  • Change in Pain intensity [Time frame: baseline, 28 day]
  • Change in Affection [Time frame: baseline, 28 day]
  • Change in Subjective perception of exertion [Time frame: baseline, 28 day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Marcelo Cardoso de Souza — Natal

Publications

  • 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. PMID 31103124
  • Cavalcanti BH, Pontes-Silva A, Souza CG, Avila MA, de Souza MC. Do Fibromyalgia Patients Have a Preferred Resistance Training Volume? Protocol for a Randomized Crossover Clinical Trial. Physiother Res Int. 2025 Oct;30(4):e70101. doi: 10.1002/pri.70101. PMID 40886126

Identifiers

NCT: NCT06424743 · UFRNpreference

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗