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

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

Interventions

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). 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

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). 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 & Collaborators

• University of the State of Santa Catarina

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2025-12-01

Completion

2025-12-15

Countries

• Brazil

Study Locations