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NCT Number: NCT06424743

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

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.

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Key information

Conditions

Fibromyalgia, Primary Chronic Pain Exercise Addiction Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marcelo Cardoso de Souza

Natal, Rio Grande do Norte, 59200-000, Brazil

Location status: Recruiting

Location contact

Marcelo C de Souza, Professor

CONTACT

[email protected]

55(84) 3342-2287

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

exercise programs with different volumes

Other names: resistance exercises

Primary outcomes

  1. Choose one of the workouts according to your preference

    Time frame: 28 day

    Preference will be assessed through the following question: "After carrying out the training sessions, which one did you prefer? Why?".

Secondary outcomes

  1. Change in Expectation

    Time frame: baseline

    The Likert Scale will be used for expectations in relation to treatment. That scale aims to assess the participant's expectations at the beginning of the study in relation to the treatment they will receive with the following questions: • "Do you think that by starting the training session with 1 set, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".

    • "Do you think that by starting the training session with 2 sets, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".
    • "Do you think that by starting the training session with 3 sets, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".

  2. Change in Pain intensity

    Time frame: baseline, 28 day

    Generalized pain intensity will be assessed using the Numerical Pain Scale (END), a self-report instrument validated for Portuguese. END has a sequence of numbers (from 0 to 10), where 0 represents "no pain" and 10 represents "the worst pain that you can imagine."

  3. Change in Affection

    Time frame: baseline, 28 day

    Affect scale will monitor pleasure or displeasure during the three resistance training will be carried out through the application of the affective valence scale (VA).

    The scale is quantified as follows: +5 to -5, corresponding, respectively, to the two antagonistic descriptors of feelings during physical exercise and/or physical activity, which may be: "very good" and "very bad".

  4. Change in Subjective perception of exertion

    Time frame: baseline, 28 day

    The quantification of the intensity of each resistance training session will be determined using the session's subjective perception of exertion (RPE) method

    . To this end, the following question: "How was your training session?" The answer will be provided, as recommended, 30 min after the end of the session, based on an adapted Borg scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcelo C de Souza, PT, PhD

CONTACT

[email protected]

55849994806892

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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