Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Protocol Based on Physical Exercise and Stretching

November 7, 2019 updated by: Fco. Javier Montanez Aguilera, Cardenal Herrera University

Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Combined Protocol Based on Physical Exercise and Muscle Stretching

This study evaluates the effect to a muscle stretching program combined with physical exercise versus a physical exercise program in patients with fibromyalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although classically this pathology was characterized by having an unknown etiology, current research suggests that the disease shows several abnormalities in the central pain processing.

Central sensitization is defined as changes in neuroplasticity of central nervous system as a result of persistent and intense sensory information nociceptive generated by peripheral and transmitted to the neurons in the dorsal horn of the cord through the nerves of the peripheral nervous system tissues, through a constant activity of C fibers and A-beta fibers.

In recent years the theory that pain is responsible for other symptoms, is changing, and it is theorized that the quality of sleep directly influences in the symptoms.

The treatment of fibromyalgia is based on trying to reduce pain and associated symptoms described above in order to improve the quality of life of these patients. Almost all revisions studying the effects of physical activity in fibromyalgia agree that it is effective in reducing the overall impact on the disease and its symptoms.

Muscle strength training aim to improve the strength, endurance and muscle power. There are few conclusive studies on the benefits of stretching and flexibility exercises on the impact of fibromyalgia.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Moncada, Valencia, Spain, 46113
        • CEU Cardenal Herrera University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be 18 years or more.
  • To be diagnosed with fibromyalgia according to the criteria established by the "American College of Rheumatology", either on the basis of its publication of 1990 or the current revision of 2010.
  • Accept to volunteer and give oral consent. Before starting the intervention must be provided written informed consent.

Exclusion Criteria:

  • Do not present any pathology in which physical exercise is contraindicated.
  • Do not suffer another serious somatic illness or severe psychological disorder. Not suffer severe dementia (MMSE <10).
  • Do not be participating at the time of the study in any other intervention of physical or psychological.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical Exercise
Aerobic physical exercise protocol of moderate intensity, for 12 weeks, 3 sessions per week, about 12 minutes. Physical activity chosen will be pedaling on a static bike.
Procedure: Physical Exercise
Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.
Experimental: Muscle Stretching
Stretching program on the main muscle groups of the body, for 12 weeks, 1sessions per week, about 45 minutes.
Procedure: Physical Exercise
Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.
Procedure: Muscle Stretching
Subjects completed one stretching session on the main muscle groups of the body weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh sleep quality index
Time Frame: At the beginning, every two weeks up to 12 weeks
The Pittsburgh Sleep Quality Index, where a lower score (0-21), better sleep quality. Follows a continuous metric scale.
At the beginning, every two weeks up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth sleepiness scale
Time Frame: At the beginning, every two weeks up to 12 weeks
The Epworth Sleepiness Scale, where a lower score (0-24), better sleep. Follows a continuous metric scale.
At the beginning, every two weeks up to 12 weeks
Sleep scale (medical outcomes study)
Time Frame: At the beginning, every two weeks up to 12 weeks
The Sleep Scale from the Medical Outcomes Study evaluates the quality of sleep with a score of (0-100), where 0 is "no problem" and 100 is "maximum problems". Follows a continuous metric scale.
At the beginning, every two weeks up to 12 weeks
Visual analog scale
Time Frame: At the beginning, every two weeks up to 12 weeks
The visual analog scale measures the perceived pain with a score ofh a (0-100), where a higher score means more pain. Follows a continuous metric scale.
At the beginning, every two weeks up to 12 weeks
Fibromyalgia impact questionnaire
Time Frame: At the beginning, every two weeks up to 12 weeks
The Fibromyalgia Impact Questionnaire follows a continuous metric scale, (0-100), where a higher score means lower quality of life.
At the beginning, every two weeks up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Principal Investigator: F Javier Montañez-Aguilera, PhD, CEU Cardenal Herrera University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 14, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEU-UCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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