FibromyalgiaNCT07734662
High-Intensity vs. Preferred-Intensity Resistance Training in Fibromyalgia
A study testing Preferred-Intensity Resistance Training Group (PIG) and High-Intensity Resistance Training Group (HIG) in people with Fibromyalgia, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial summary
This randomized crossover clinical trial aims to verify and compare the effects of high-intensity (HIG) and preferred-intensity (PIG) resistance training on the health of women with fibromyalgia (FM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Preferred-Intensity Resistance Training Group (PIG) and High-Intensity Resistance Training Group (HIG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2024to 15 Dec 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed informed consent to participate in the study.
- Female participants aged 18 years or older.
- Confirmed clinical diagnosis of fibromyalgia documented by a medical report.
- Not currently participating in any regular physical activity involving strength or resistance training.
Who cannot join
- Presence of physical or cognitive conditions that impair the execution of the prescribed exercises.
- Pregnancy.
- Medical contraindication to physical exercise.
- Engagement in physical activities such as resistance training, Pilates, swimming, calisthenics, yoga, or martial arts.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Ciências da Saúde e do Esporte / Universidade do Estado de Santa Catarina
Florianópolis, Santa Catarina, 88080-350
About this study
Official title: Effects of High-Intensity Versus Preferred-Intensity Resistance Training in the Treatment of Women With Fibromyalgia: A Randomized Crossover Clinical Trial
This randomized crossover clinical trial aims to verify and compare the effects of high-intensity (HIG) and preferred-intensity (PIG) resistance training on the health of women with fibromyalgia (FM). Secondary objectives include verifying differences after 4, 8, and 16 sessions, as well as evaluating the proportion of participants who achieve the minimal clinically important difference in the disease impact/severity outcome.
Patients included in the study will be randomized into two groups: HIG and PIG. Sixteen training sessions will be conducted twice a week, with each session lasting approximately 60 minutes. Subsequently, patients will undergo a minimum 8-week washout period (detraining) and will then be allocated to the other intervention group.
The primary outcome is disease impact evaluated using the Revised Fibromyalgia Impact Questionnaire (FIQR). Secondary outcomes include mood states evaluated by the Brunel Mood Scale (BRUMS), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), anxiety levels evaluated with the Beck Anxiety Inventory (BAI), and depression levels evaluated with the Beck Depression Inventory (BDI). Attendance and absence data will also be collected, as well as information regarding program discontinuation.
- Conditions
- Fibromyalgia
- Being tested
- Preferred-Intensity Resistance Training Group (PIG), High-Intensity Resistance Training Group (HIG)
- Keywords
- Mental Health
- Medical subject headings
- Fibromyalgia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred-Intensity Resistance Training Group (PIG)Device
Also called Exercise
Participants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Prior to the intervention, participants complete 3 familiarization sessions without intensity control to learn proper exercise execution and facility equipment. Each session includes a low-load warm-up (1 lower-body and 2 upper-body exercises), main part of the session (chest press, seated cable row, squat, leg press, shoulder press, and standing calf raise), and 10 minutes of static stretching cooldown. Participants perform 3 sets of 8-12 repetitions with 1-2 minutes of rest between sets. Load selection is based on the participant's perceived capacity, with instructions that the weight may lead to concentric failure. Load progression occurs when exercises are performed with proper technique and the participant requests an increase; all loads are continuously logged.
High-Intensity Resistance Training Group (HIG)Device
Also called Exercise
Participants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Prior to the intervention, participants complete 3 familiarization sessions without intensity control to learn proper exercise execution and facility equipment. Each session includes a low-load warm-up (1 lower-body and 2 upper-body exercises), themain part of the sessi (chest press, seated cable row, squat, leg press, shoulder press, and standing calf raise), and 10 minutes of static stretching cooldown. Participants perform 4 sets of 6 repetitions with 2 minutes of rest between sets, encouraged to reach concentric failure on the final set.Load increases by 10%-20% following proper execution across two consecutive sessions; all loads are continuously logged.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity resistance training(HIG) | Experimental | Participants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Sessions take place in an academic exercise facility under the supervision of qualified physical therapists, exercise physiologists, or trained undergraduate students.
Temporary adaptations (e.g., load reduction, modified range of motion, bench angle adjustments, or box squats) are applied as needed for fibromyalgia symptoms to support progression toward standard execution. Adverse events, attendance, and reasons for missed sessions or dropouts are systematically monitored and recorded.
Dosage: 4 sets of 6 repetitions with 2 minutes of rest between sets. Participants are encouraged to reach concentric failure on the last set.
Load: Load increases by 10% to 20% after proper execution for two consecutive sessions, under supervisor guidance. Receives: Device: High-Intensity Resistance Training Group (HIG) |
| Preferred-intensity resistance training (PIG) | Experimental | Participants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Sessions take place in an academic exercise facility under the supervision of qualified physical therapists, exercise physiologists, or trained undergraduate students.
Temporary adaptations (e.g., load reduction, modified range of motion, bench angle adjustments, or box squats) are applied as needed for fibromyalgia symptoms to support progression toward standard execution. Adverse events, attendance, and reasons for missed sessions or dropouts are systematically monitored and recorded.
Dosage: 3 sets of 8-12 repetitions with 1 to 2 minutes of rest between sets. Load : Participants self-select the load based on their perceived capacity, with the suggestion that it could lead to concentric failure. Load increases when the participant executes the movement correctly and requests Receives: Device: Preferred-Intensity Resistance Training Group (PIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and impact of fibromyalgia
The Revised Fibromyalgia Impact Questionnaire (FIQR) evaluates the impact of fibromyalgia on patients' quality of life over the preceding 7 days (Lupi et al., 2017). The instrument assesses symptoms and daily difficulties using a 0-to-10 numerical rating scale, where higher scores indicate greater disease impact. The 21-item questionnaire yields a total score ranging from 0 to 100, composed of three subscales: Function (0-30), Overall Impact (0-20), and Symptoms (0-50). Total scores can also be classified into severity categories: 0-23 (remission), 24-40 (mild), 41-63 (moderate), 64-82 (severe), and ≥ 83 (very severe) (Salaffi et al., 2021).
Measured: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
Secondary outcomes (4)
Mood States (BRUMS)
Assessed using the Brunel Mood Scale (BRUMS), a 24-item questionnaire scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely). It measures six subscales: Tension, Depression, Anger, Vigor, Fatigue, and Confusion. Each subscale score ranges from 0 to 16, with higher scores reflecting greater intensity of the respective mood state.
Measured: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
Sleep Quality (PSQI)
Assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep quality over the past week across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Global scores range from 0 to 21, where values of five or higher indicate poor quality.
Measured: Baseline, 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
Anxiety Levels (BAI)
Assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Items are scored on a scale from 0 to 3, yielding a total score ranging from 0 to 63, where higher scores indicate higher levels of anxiety.
Measured: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
Depression Levels (BDI)
Assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire. Items are scored on a scale from 0 to 3, yielding a total score ranging from 0 to 63, where higher scores indicate higher levels of depressive symptoms.
Measured: Baseline, and 8 weeks (after 16 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jul 2024
- Primary completion1 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Crossover
- Model description
- This is a randomized crossover clinical trial in which participants will be randomized to one of two sequences: performing high-intensity resistance training, followed by an 8-week washout period, and then performing preferred-intensity resistance training; or performing preferred-intensity resistance training, followed by an 8-week washout period, and then performing high-intensity resistance training. This study is conducted at a single center. Participants complete the questionnaires at baseline, after 4 sessions, after 8 sessions, and after 16 sessions.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loiane Cristina de Souza, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734662
- Sponsor's protocol ID
- 40877420.0.0000.0118
- Other IDs
- 40877420.0.0000.0118
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vilarino GT, Andreato LV, de Souza LC, Branco JHL, Andrade A. Effects of resistance training on the mental health of patients with fibromyalgia: a systematic review. Clin Rheumatol. 2021 Nov;40(11):4417-4425. doi: 10.1007/s10067-021-05738-z. Epub 2021 May 14.
PubMed 33987785Vilarino GT, Branco JHL, de Souza LC, Andrade A. Effects of resistance training on the physical symptoms and functional capacity of patients with fibromyalgia: a systematic review and meta-analysis of randomized clinical trials. Ir J Med Sci. 2023 Aug;192(4):2001-2014. doi: 10.1007/s11845-022-03205-5. Epub 2022 Nov 3.
PubMed 36326999
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Versus Preferred-Intensity Resistance Training in the Treatment of Women With Fibromyalgia: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07734662
- Acronym / sponsor ID
- 40877420.0.0000.0118
- Conditions
- Fibromyalgia
- Keywords
- Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 29 Jul 2026 (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.
This randomized crossover clinical trial aims to verify and compare the effects of high-intensity (HIG) and preferred-intensity (PIG) resistance training on the health of women with fibromyalgia (FM). Secondary objectives include verifying differences after 4, 8, and 16 sessions, as well as evaluating the proportion of participants who achieve the minimal clinically important difference in the disease impact/severity outcome.
Patients included in the study will be randomized into two groups: HIG and PIG. Sixteen training sessions will be conducted twice a week, with each session lasting approximately 60 minutes. Subsequently, patients will undergo a minimum 8-week washout period (detraining) and will then be allocated to the other intervention group.
The primary outcome is disease impact evaluated using the Revised Fibromyalgia Impact Questionnaire (FIQR). Secondary outcomes include mood states evaluated by the Brunel Mood Scale (BRUMS), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), anxiety levels evaluated with the Beck Anxiety Inventory (BAI), and depression levels evaluated with the Beck Depression Inventory (BDI). Attendance and absence data will also be collected, as well as information regarding program discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized crossover clinical trial in which participants will be randomized to one of two sequences: performing high-intensity resistance training, followed by an 8-week washout period, and then performing preferred-intensity resistance training; or performing preferred-intensity resistance training, followed by an 8-week washout period, and then performing high-intensity resistance training. This study is conducted at a single center. Participants complete the questionnaires at baseline, after 4 sessions, after 8 sessions, and after 16 sessions.
| Arm | Type | Receives |
|---|---|---|
| High-intensity resistance training(HIG) | Experimental | Device: High-Intensity Resistance Training Group (HIG)Participants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Sessions take place in an academic exercise facility under the supervision of qualified physical therapists, exercise physiologists, or trained undergraduate students. Temporary adaptations (e.g., load reduction, modified range of motion, bench angle adjustments, or box squats) are applied as needed for fibromyalgia symptoms to support progression toward standard execution. Adverse events, attendance, and reasons for missed sessions or dropouts are systematically monitored and recorded. Dosage: 4 sets of 6 repetitions with 2 minutes of rest between sets. Participants are encouraged to reach concentric failure on the last set. Load: Load increases by 10% to 20% after proper execution for two consecutive sessions, under supervisor guidance. |
| Preferred-intensity resistance training (PIG) | Experimental | Device: Preferred-Intensity Resistance Training Group (PIG)Participants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Sessions take place in an academic exercise facility under the supervision of qualified physical therapists, exercise physiologists, or trained undergraduate students. Temporary adaptations (e.g., load reduction, modified range of motion, bench angle adjustments, or box squats) are applied as needed for fibromyalgia symptoms to support progression toward standard execution. Adverse events, attendance, and reasons for missed sessions or dropouts are systematically monitored and recorded. Dosage: 3 sets of 8-12 repetitions with 1 to 2 minutes of rest between sets. Load : Participants self-select the load based on their perceived capacity, with the suggestion that it could lead to concentric failure. Load increases when the participant executes the movement correctly and requests |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed informed consent to participate in the study.
- Female participants aged 18 years or older.
- Confirmed clinical diagnosis of fibromyalgia documented by a medical report.
- Not currently participating in any regular physical activity involving strength or resistance training.
Key exclusion criteria (4 listed)
- Presence of physical or cognitive conditions that impair the execution of the prescribed exercises.
- Pregnancy.
- Medical contraindication to physical exercise.
- Engagement in physical activities such as resistance training, Pilates, swimming, calisthenics, yoga, or martial arts.
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 |
|---|---|---|
| Preferred-Intensity Resistance Training Group (PIG)Also: ExerciseParticipants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Prior to the intervention, participants complete 3 familiarization sessions without intensity control to learn proper exercise execution and facility equipment. Each session includes a low-load warm-up (1 lower-body and 2 upper-body exercises), main part of the session (chest press, seated cable row, squat, leg press, shoulder press, and standing calf raise), and 10 minutes of static stretching cooldown. Participants perform 3 sets of 8-12 repetitions with 1-2 minutes of rest between sets. Load selection is based on the participant's perceived capacity, with instructions that the weight may lead to concentric failure. Load progression occurs when exercises are performed with proper technique and the participant requests an increase; all loads are continuously logged. | Device | Preferred-intensity resistance training (PIG) |
| High-Intensity Resistance Training Group (HIG)Also: ExerciseParticipants complete an 8-week supervised resistance training program consisting of 2 weekly 60-minute sessions (up to 16 sessions total, with flexibility to reschedule missed sessions due to clinical reasons). Prior to the intervention, participants complete 3 familiarization sessions without intensity control to learn proper exercise execution and facility equipment. Each session includes a low-load warm-up (1 lower-body and 2 upper-body exercises), themain part of the sessi (chest press, seated cable row, squat, leg press, shoulder press, and standing calf raise), and 10 minutes of static stretching cooldown. Participants perform 4 sets of 6 repetitions with 2 minutes of rest between sets, encouraged to reach concentric failure on the final set.Load increases by 10%-20% following proper execution across two consecutive sessions; all loads are continuously logged. | Device | High-intensity resistance training(HIG) |
Primary outcome
Severity and impact of fibromyalgia
Time frame: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
The Revised Fibromyalgia Impact Questionnaire (FIQR) evaluates the impact of fibromyalgia on patients' quality of life over the preceding 7 days (Lupi et al., 2017). The instrument assesses symptoms and daily difficulties using a 0-to-10 numerical rating scale, where higher scores indicate greater disease impact. The 21-item questionnaire yields a total score ranging from 0 to 100, composed of three subscales: Function (0-30), Overall Impact (0-20), and Symptoms (0-50). Total scores can also be classified into severity categories: 0-23 (remission), 24-40 (mild), 41-63 (moderate), 64-82 (severe), and ≥ 83 (very severe) (Salaffi et al., 2021).
4 secondary outcomes
Mood States (BRUMS)
Time frame: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
Sleep Quality (PSQI)
Time frame: Baseline, 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
Anxiety Levels (BAI)
Time frame: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
Depression Levels (BDI)
Time frame: Baseline, and 8 weeks (after 16 sessions)
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 29 Jul 2026.
- Background: PubMed 33987785Vilarino GT, Andreato LV, de Souza LC, Branco JHL, Andrade A. Effects of resistance training on the mental health of patients with fibromyalgia: a systematic review. Clin Rheumatol. 2021 Nov;40(11):4417-4425. doi: 10.1007/s10067-021-05738-z. Epub 2021 May 14.
- Background: PubMed 36326999Vilarino GT, Branco JHL, de Souza LC, Andrade A. Effects of resistance training on the physical symptoms and functional capacity of patients with fibromyalgia: a systematic review and meta-analysis of randomized clinical trials. Ir J Med Sci. 2023 Aug;192(4):2001-2014. doi: 10.1007/s11845-022-03205-5. Epub 2022 Nov 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred-Intensity Resistance Training Group (PIG) and High-Intensity Resistance Training Group (HIG) in people with Fibromyalgia, run by University of the State of Santa Catarina 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 4 inclusion and 4 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 29 Jul 2026. 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?
Severity and impact of fibromyalgia (time frame: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)). 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 NCT07734662, which also lists 2 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 29 Jul 2026.