FibromyalgiaNCT05646641
Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms
A study testing Strength exercise in people with Fibromyalgia, run by University of Beira Interior at 1 site in Brazil.
Trial summary
The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Strength exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Oct 2024to 7 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria
- at least 18 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Strength Training in Fibromyalgia Affect Balance, Neuromuscular Performance and Symptoms? A 12 Week of a Randomized Controlled Trial
The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.
Read the detailed description
Thirty participants will be recruited. Volunteers will be randomly assigned to the control group or experimental group. Before the training period, symptoms, balance and neuromuscular performance will be assessed. Participants in the experimental group will perform strength training twice a week (50 min each) for eight weeks. Then, four weeks of detraining will be completed.
- Conditions
- Fibromyalgia
- Being tested
- Strength exercise
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength exerciseOther
The protocol consists of 8 weeks of training, consisting of 16 sessions of 50 minutes, twice a week on alternate days.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 8 weeks of strength training. Receives: Other: Strength exercise |
| Control | No intervention | Maintain their usual medical treatment and daily routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Force plate
Measured: Change from Baseline balance at week 9
Balance
Force plate
Measured: Change from Baseline balance at week 12
Balance
Force plate
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from week 9 neuromuscular performance at week 12
Secondary outcomes (6)
Fibromyalgia impact questionnaire
Questionnaire to ccess information on the functional capacity and health status of individuals with fibromyalgia. Composed of 20 questions. , the values vary from 0 to 100, in which the higher the value, the greater the impact of fibromyalgia.
Measured: Baseline, week 9, week 12
Pain intensity
Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.
Measured: baseline and everyday until the week 12
Anxiety
Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.
Measured: baseline and everyday until the week 12
Quality of sleep
Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.
Measured: baseline and everyday until the week 12
Fatigue
Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.
Measured: baseline and everyday until the week 12
Mood state
Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.
Measured: baseline and everyday until the week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start5 Oct 2024
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Responsible party
- Principal investigator, Maria Luiza Laurentino de Albuquerque, University of Beira Interior
- Investigators
- Investigator, Study director, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646641
- Sponsor's protocol ID
- D2834
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37188309
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Strength Training in Fibromyalgia Affect Balance, Neuromuscular Performance and Symptoms? A 12 Week of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05646641
- Acronym / sponsor ID
- D2834
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 12 Dec 2022 (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.
The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.
Detailed description
Thirty participants will be recruited. Volunteers will be randomly assigned to the control group or experimental group. Before the training period, symptoms, balance and neuromuscular performance will be assessed. Participants in the experimental group will perform strength training twice a week (50 min each) for eight weeks. Then, four weeks of detraining will be completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Strength exercise8 weeks of strength training. |
| Control | No intervention | –Maintain their usual medical treatment and daily routines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria
- at least 18 years old
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Strength exerciseThe protocol consists of 8 weeks of training, consisting of 16 sessions of 50 minutes, twice a week on alternate days. | Other | Exercise |
Primary outcome
Balance
Time frame: Change from Baseline balance at week 9
Force plate
Balance
Time frame: Change from Baseline balance at week 12
Force plate
Balance
Time frame: Change from week 9 balance at week 12
Force plate
Neuromuscular performance
Time frame: Change from Baseline neuromuscular performance at week 9
Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.
Neuromuscular performance
Time frame: Change from Baseline neuromuscular performance at week 12
Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.
Neuromuscular performance
Time frame: Change from week 9 neuromuscular performance at week 12
Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.
6 secondary outcomes
Fibromyalgia impact questionnaire
Time frame: Baseline, week 9, week 12
Pain intensity
Time frame: baseline and everyday until the week 12
Anxiety
Time frame: baseline and everyday until the week 12
Quality of sleep
Time frame: baseline and everyday until the week 12
Fatigue
Time frame: baseline and everyday until the week 12
Mood state
Time frame: baseline and everyday until the week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 37188309Albuquerque 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.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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. This study is not recruiting at the moment.
Investigator study director
University of Beira Interior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength exercise in people with Fibromyalgia, run by University of Beira Interior 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: finished, as of the sponsor's last update on 31 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Change from Baseline balance at week 9). The study lists 6 primary outcomes in all. 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 NCT05646641, which also lists 1 linked publication.
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 31 Dec 2025.