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.
Inclusion Criteria:
Exclusion Criteria:
Although blinding is not fully possible, several measures were taken to minimize bias: evaluators conduct the baseline assessments in an interview format, while all subsequent assessments are self-administered by the participants. Patients are aware they are participating in resistance training, but are blinded to the different intensity conditions. Additionally, the investigator responsible for randomization is not directly involved in the intervention delivery or outcome evaluations.
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.
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
Florianópolis, Santa Catarina 88080-350, Brazil
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