Fibromyalgia, PrimaryNCT06424743
Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training
A study testing exercise in people with Fibromyalgia, Primary and Chronic Pain, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Primary, Chronic Pain, Exercise Addiction
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 to 65
- Have a diagnosis of fibromyalgia according to the ACR 2016 criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Marcelo Cardoso de Souza
Natal, Rio Grande do Norte, 59200-000
Marcelo C de Souza, Professor, 55(84) 3342-2287, marcellogv@hotmail.com
About this study
Official title: Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover
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.
Read the 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.
- Conditions
- Fibromyalgia, Primary, Chronic Pain, Exercise Addiction
- Being tested
- exercise
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Also called resistance exercises
exercise programs with different volumes
| Study group | Role | What they receive |
|---|---|---|
| 1 set | Experimental | Training A Bench press, Pull front, Leg press and seated flexor
1 series 10 repetitions with 60% 1RM, 2' minute interval Receives: Other: exercise |
| 2 sets | Experimental | Training B Bench press, Pull front, Leg press and seated flexor 2 series 10 repetitions with 60% 1RM, 2' minute interval Receives: Other: exercise |
| 3 sets | Experimental | Training C Bench press, Pull front, Leg press and seated flexor 3 series 10 repetitions with 60% 1RM, 2' minute interval Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?".
Measured: 28 day
Secondary outcomes (4)
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".
Measured: 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."
Measured: 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".
Measured: 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.
Measured: baseline, 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jul 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Cardoso de Souza, PT, PhD., Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424743
- Sponsor's protocol ID
- UFRNpreference
- Status last verified
- Jul 2025
- First submitted
- 16 May 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is not a plan to make individual participant data (IPD) available to other researchers.
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.
PubMed 31103124Cavalcanti BH, Pontes-Silva A, Reboucas GM, Matos AP, Souza CG, Avila MA, de Souza MC. Preference for Resistance Training Volume After Acute Exercise in Women With Fibromyalgia: A Randomized Crossover Clinical Trial. Physiother Res Int. 2026 Oct;31(4):e70364. doi: 10.1002/pri.70364.
PubMed 42886018Cavalcanti 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.
PubMed 40886126
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover
- ClinicalTrials.gov ID
- NCT06424743
- Acronym / sponsor ID
- UFRNpreference
- Conditions
- Fibromyalgia, Primary, Chronic Pain, Exercise Addiction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1 set | Experimental | Other: exerciseTraining A Bench press, Pull front, Leg press and seated flexor 1 series 10 repetitions with 60% 1RM, 2' minute interval |
| 2 sets | Experimental | Other: exerciseTraining B Bench press, Pull front, Leg press and seated flexor 2 series 10 repetitions with 60% 1RM, 2' minute interval |
| 3 sets | Experimental | Other: exerciseTraining C Bench press, Pull front, Leg press and seated flexor 3 series 10 repetitions with 60% 1RM, 2' minute interval |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 to 65
- Have a diagnosis of fibromyalgia according to the ACR 2016 criteria
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseAlso: resistance exercisesexercise programs with different volumes | Other | 1 set, 2 sets, 3 sets |
Primary outcome
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?".
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 31103124Silva 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.
- Derived from this study: PubMed 42886018Cavalcanti BH, Pontes-Silva A, Reboucas GM, Matos AP, Souza CG, Avila MA, de Souza MC. Preference for Resistance Training Volume After Acute Exercise in Women With Fibromyalgia: A Randomized Crossover Clinical Trial. Physiother Res Int. 2026 Oct;31(4):e70364. doi: 10.1002/pri.70364.
- Derived from this study: PubMed 40886126Cavalcanti 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.
- Individual participant dataSharing planned: No. there is not a plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Fibromyalgia, Primary and Chronic Pain, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelo C de Souza, PT, PhD (55849994806892, marcelo.cardoso@ufrn.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choose one of the workouts according to your preference (time frame: 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.