NCT06424743

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

May 16, 2024

Last Update Submit

July 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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?".

    28 day

Secondary Outcomes (4)

  • Change in Expectation

    baseline

  • Change in Pain intensity

    baseline, 28 day

  • Change in Affection

    baseline, 28 day

  • Change in Subjective perception of exertion

    baseline, 28 day

Study Arms (3)

1 set

EXPERIMENTAL

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

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

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

Other: exercise

Interventions

exercise programs with different volumes

Also known as: resistance exercises
1 set2 sets3 sets

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 to 65
  • Have a diagnosis of fibromyalgia according to the ACR 2016 criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcelo Cardoso de Souza

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

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Marcelo C de Souza, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Professor of Department of Physiotherapy

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

July 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

there is not a plan to make individual participant data (IPD) available to other researchers.

Locations