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Completed

NCT Number: NCT02876965

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

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Sleep Stretch

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEU Cardenal Herrera University

Moncada, Valencia, 46113, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Muscle Stretching

Procedure

Subjects completed one stretching session on the main muscle groups of the body weekly.

Physical exercise

Procedure

Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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