Effects of Therapeutic Exercise in Patients With Fibromyalgia

NCT ID: NCT04817605

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2022-06-20

Brief Summary

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Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.

The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.

For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.

The variables are measured at the beginning and end of treatment.

Detailed Description

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Conditions

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Therapeutic Exercise Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Therapy

Group Type EXPERIMENTAL

Therapeutic Exercise

Intervention Type OTHER

Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Interventions

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Therapeutic Exercise

Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed medically with Fibromyalgia
* Diagnosed according to the American College of Rheumatology criteria
* Agreement to attend to treatment sessions

Exclusion Criteria

* Any kind of contraindications for physical activity
* Other kind of diseases that could limit the intervention
* Previous surgery last year
* Medication modifications in the last 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Sandra Jiménez

University of Valladolid Faculty of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sandra Jiménez Jiménez-del-Barrio

Soria, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UVa

Identifier Type: -

Identifier Source: org_study_id

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