Fibromyalgia
Conditions
Keywords
Mental Health
Brief 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). 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.
Interventions
DEVICEPreferred-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). 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.
DEVICEHigh-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). 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.
Sponsors
University of the State of Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity and impact of fibromyalgia | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood States (BRUMS) | Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions) | 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. |
| Sleep Quality (PSQI) | Baseline, 4 weeks (8 sessions), and 8 weeks (after 16 sessions) | 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. |
| Anxiety Levels (BAI) | Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions) | 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. |
| Depression Levels (BDI) | Baseline, and 8 weeks (after 16 sessions) | 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. |
Countries
Brazil
Outcome results
None listed