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

NCT ID: NCT06424743

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-01

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.

Conditions

Fibromyalgia, Primary; Chronic Pain; Exercise Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1 set

Training A Bench press, Pull front, Leg press and seated flexor

1 series 10 repetitions with 60% 1RM, 2' minute interval

Group Type: EXPERIMENTAL

exercise

Intervention Type: OTHER

exercise programs with different volumes

2 sets

Training B Bench press, Pull front, Leg press and seated flexor 2 series 10 repetitions with 60% 1RM, 2' minute interval

Group Type: EXPERIMENTAL

exercise

Intervention Type: OTHER

exercise programs with different volumes

3 sets

Training C Bench press, Pull front, Leg press and seated flexor 3 series 10 repetitions with 60% 1RM, 2' minute interval

Group Type: EXPERIMENTAL

exercise

Intervention Type: OTHER

exercise programs with different volumes

Interventions

exercise

exercise programs with different volumes

Intervention Type: OTHER

Other Intervention Names

resistance exercises

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Cardoso de Souza, PT, PhD.

Principal Investigator and Professor of Department of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marcelo Cardoso de Souza

Natal, Rio Grande do Norte, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marcelo C de Souza, PT, PhD

Role: CONTACT

marcelo.cardoso@ufrn.br

55849994806892

Facility Contacts

Marcelo C de Souza, Professor

Role: primary

marcellogv@hotmail.com

55(84) 3342-2287

References

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.

Reference Type: RESULT

PMID: 31103124 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40886126 (View on PubMed)

Other Identifiers

UFRNpreference

Identifier Type: -

Identifier Source: org_study_id