High-Intensity vs. Preferred-Intensity Resistance Training in Fibromyalgia

NCT07734662 | Completed

• 1 other identifier: 40877420.0.0000.0118
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Mental Health

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)

Secondary Outcomes (4)

• Mood States (BRUMS)

  Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)

• Sleep Quality (PSQI)

  Baseline, 4 weeks (8 sessions), and 8 weeks (after 16 sessions)

• Anxiety Levels (BAI)

  Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)

• Depression Levels (BDI)

  Baseline, and 8 weeks (after 16 sessions)

Study Arms (2)

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.

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

Device: Preferred-Intensity Resistance Training Group (PIG)

Interventions

Preferred-Intensity Resistance Training Group (PIG) DEVICE

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.

Also known as: Exercise

Preferred-intensity resistance training (PIG)

High-Intensity Resistance Training Group (HIG) DEVICE

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.

Also known as: Exercise

High-intensity resistance training(HIG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Centro de Ciências da Saúde e do Esporte / Universidade do Estado de Santa Catarina

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

Related Publications (2)

• 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.

  PMID: 33987785 BACKGROUND

• Vilarino 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.

  PMID: 36326999 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Psychological Well-Being

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Doctoral Student

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 15, 2025
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)