NCT05646641

Brief Summary

The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 29, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 29, 2022

Last Update Submit

December 26, 2025

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (6)

  • Balance

    Force plate

    Change from Baseline balance at week 9

  • Balance

    Force plate

    Change from Baseline balance at week 12

  • Balance

    Force plate

    Change from week 9 balance at week 12

  • Neuromuscular performance

    Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.

    Change from Baseline neuromuscular performance at week 9

  • Neuromuscular performance

    Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.

    Change from Baseline neuromuscular performance at week 12

  • Neuromuscular performance

    Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.

    Change from week 9 neuromuscular performance at week 12

Secondary Outcomes (6)

  • Fibromyalgia impact questionnaire

    Baseline, week 9, week 12

  • Pain intensity

    baseline and everyday until the week 12

  • Anxiety

    baseline and everyday until the week 12

  • Quality of sleep

    baseline and everyday until the week 12

  • Fatigue

    baseline and everyday until the week 12

  • +1 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

8 weeks of strength training.

Other: Strength exercise

Control

NO INTERVENTION

Maintain their usual medical treatment and daily routines

Interventions

Strength exerciseOTHER

The protocol consists of 8 weeks of training, consisting of 16 sessions of 50 minutes, twice a week on alternate days.

Exercise

Eligibility Criteria

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

You may qualify if:

  • medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria
  • at least 18 years old

You may not qualify if:

  • severe comorbidity or any other type of condition that negatively influences participation in the training program
  • cognitive disorders
  • heart problems
  • surgeries or fractures in the last 6 months
  • regular practice of physical exercises in the least 3 months before program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (1)

  • Albuquerque MLL, Monteiro D, Alvarez MC, Vilarino GT, Andrade A, Neiva HP. Effects of strength training in fibromyalgia on balance, neuromuscular performance, and symptomatic analysis: a 12-week study protocol. Front Neurol. 2023 Apr 28;14:1149268. doi: 10.3389/fneur.2023.1149268. eCollection 2023.

    PMID: 37188309DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Investigator

    University of Beira Interior

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 12, 2022

Study Start

October 5, 2024

Primary Completion

August 7, 2025

Study Completion

August 7, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)