## Protocol Section
### Identification Module
**NCT ID:** NCT06424743

**Brief Title:** Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training

**Official Title:** Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover

#### Organization Study ID Info
**ID:** UFRNpreference
#### Organization
**Class:** OTHER
**Full Name:** Universidade Federal do Rio Grande do Norte
### Status Module
#### Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidade Federal do Rio Grande do Norte

#### Responsible Party

**Investigator Affiliation:** Universidade Federal do Rio Grande do Norte

**Investigator Full Name:** Marcelo Cardoso de Souza, PT, PhD.

**Investigator Title:** PT, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Fibromyalgia is a painful syndrome of unknown etiology, which affects 2% of world population, with symptoms such as: pain, unrefreshing sleep, fatigue and mood disorders. It is already established in the literature that resistance training is part of the non- pharmacological treatment for patients with fibromyalgia. The big gap is about the quantity adequate and/or recommended exercise volume, despite some studies with exercise volumes different resistance trainings show improvements, we do not have a direction, besides We still do not know whether there is a preference for these patients in different resistance training volumes.

**Detailed Description:** Objective: Assess training volume preference resisted in women with fibromyalgia.

Method: Crossover randomized clinical trial, randomized and blind. 36 women with fibromyalgia will be evaluated, who will undergo three resistance training programs with different training volumes. The primary outcome will be patient preference in relation to training volumes, and the secondary ones will be the patient expectation, pain intensity, affect and subjective perception of exertion.

Analysis statistics: For the primary outcome preference, the number of choices will be counted of the 3 types of training in percentage form. Regarding the analysis of the primary outcome we will summarize the patient's preference in a contingency table, we will compare the proportions using the Chi-square test, and finally we will check the effect size of the observed differences. For secondary outcomes, statistical analyzes will be performed by a blind statistician using commercial software. The Kolmogorov-Smirnov test will be applied to verify the distribution of data and Levene's test will be used to analyze the homogeneity of variance. The Bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times. One 5% significance level and 95% CI will be adopted for all statistical analyses. ethic and dissemination: The results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings.

### Conditions Module

**Conditions:**

- Fibromyalgia, Primary

- Chronic Pain

- Exercise Addiction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Patients will be allocated to 1 of three groups: 1 set, 2 sets, or 3 sets of resistance exercise. In the next sessions they will be allocated to the series he has not performed yet.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Training A Bench press, Pull front, Leg press and seated flexor

1 series 10 repetitions with 60% 1RM, 2' minute interval

**Intervention Names:**

- Other: exercise

**Label:** 1 set

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Training B Bench press, Pull front, Leg press and seated flexor 2 series 10 repetitions with 60% 1RM, 2' minute interval

**Intervention Names:**

- Other: exercise

**Label:** 2 sets

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Training C Bench press, Pull front, Leg press and seated flexor 3 series 10 repetitions with 60% 1RM, 2' minute interval

**Intervention Names:**

- Other: exercise

**Label:** 3 sets

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1 set

- 2 sets

- 3 sets

**Description:** exercise programs with different volumes

**Name:** exercise

**Other Names:**

- resistance exercises

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Preference will be assessed through the following question: "After carrying out the training sessions, which one did you prefer? Why?".

**Measure:** Choose one of the workouts according to your preference

**Time Frame:** 28 day

#### Secondary Outcomes

**Description:** The Likert Scale will be used for expectations in relation to treatment. That scale aims to assess the participant's expectations at the beginning of the study in relation to the treatment they will receive with the following questions: • "Do you think that by starting the training session with 1 set, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".

* "Do you think that by starting the training session with 2 sets, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".
* "Do you think that by starting the training session with 3 sets, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".

**Measure:** Change in Expectation

**Time Frame:** baseline

**Description:** Generalized pain intensity will be assessed using the Numerical Pain Scale (END), a self-report instrument validated for Portuguese. END has a sequence of numbers (from 0 to 10), where 0 represents "no pain" and 10 represents "the worst pain that you can imagine."

**Measure:** Change in Pain intensity

**Time Frame:** baseline, 28 day

**Description:** Affect scale will monitor pleasure or displeasure during the three resistance training will be carried out through the application of the affective valence scale (VA).

The scale is quantified as follows: +5 to -5, corresponding, respectively, to the two antagonistic descriptors of feelings during physical exercise and/or physical activity, which may be: "very good" and "very bad".

**Measure:** Change in Affection

**Time Frame:** baseline, 28 day

**Description:** The quantification of the intensity of each resistance training session will be determined using the session's subjective perception of exertion (RPE) method

. To this end, the following question: "How was your training session?" The answer will be provided, as recommended, 30 min after the end of the session, based on an adapted Borg scale.

**Measure:** Change in Subjective perception of exertion

**Time Frame:** baseline, 28 day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women aged 18 to 65
* Have a diagnosis of fibromyalgia according to the ACR 2016 criteria

Exclusion Criteria:

* Have performed resistance training in the last 6 months
* Having another associated rheumatic condition
* Have a trip or appointment scheduled that requires absence for the next 4 (four) weeks from the start of the survey;
* Women with musculoskeletal injuries in the upper and/or lower limbs
* Have heart problems that prevent maximal efforts and submaximums

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** marcelo.cardoso@ufrn.br

**Name:** Marcelo C de Souza, PT, PhD

**Phone:** 55849994806892

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Natal

**Country:** Brazil

**Facility:** Marcelo Cardoso de Souza

**State:** RN

**Zip:** 59200-000

### IPD Sharing Statement Module

**Description:** there is not a plan to make individual participant data (IPD) available to other researchers.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Silva HJA, Assuncao Junior JC, de Oliveira FS, Oliveira JMP, Figueiredo Dantas GA, Lins CAA, de Souza MC. Sophrology versus resistance training for treatment of women with fibromyalgia: A randomized controlled trial. J Bodyw Mov Ther. 2019 Apr;23(2):382-389. doi: 10.1016/j.jbmt.2018.02.005. Epub 2018 Feb 12.

**PMID:** 31103124

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M8486

- Name: Fibromyalgia

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M12161

- Name: Myofascial Pain Syndromes

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M19100

- Name: Behavior, Addictive

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005356

- Term: Fibromyalgia

- ID: D000009209

- Term: Myofascial Pain Syndromes

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-31
