An interventional study of exercise in Fibromyalgia, Primary, Chronic Pain and Exercise Addiction, sponsored by Universidade Federal do Rio Grande do Norte. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Universidade Federal do Rio Grande do Norte is the lead sponsor of 86 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Training A Bench press, Pull front, Leg press and seated flexor 1 series 10 repetitions with 60% 1RM, 2' minute interval
Other: exercise
Training B Bench press, Pull front, Leg press and seated flexor 2 series 10 repetitions with 60% 1RM, 2' minute interval
Other: exercise
Training C Bench press, Pull front, Leg press and seated flexor 3 series 10 repetitions with 60% 1RM, 2' minute interval
Other: exercise
exercise programs with different volumes
Also known as: resistance exercises
Choose one of the workouts according to your preference
Preference will be assessed through the following question: "After carrying out the training sessions, which one did you prefer? Why?".
Time frame: 28 day
Change in Expectation
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".
Time frame: baseline
Change in Pain intensity
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."
Time frame: baseline, 28 day
Change in Affection
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".
Time frame: baseline, 28 day
Change in Subjective perception of exertion
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.
Time frame: baseline, 28 day
Plan to share: No — there is not a plan to make individual participant data (IPD) available to other researchers.
Started Jul 2025 (actual). Primary completion is estimated for Sep 2026, 14 months after the start.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 14 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Universidade Federal do Rio Grande do Norte