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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02876965
Enrollment
40
Registered
2016-08-24
Start date
2016-08-31
Completion date
2017-03-31
Last updated
2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Sleep, Stretch

Brief summary

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

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.

Interventions

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

PROCEDUREPhysical Exercise

Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.

Sponsors

Cardenal Herrera University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh sleep quality indexAt the beginning, every two weeks up to 12 weeksThe Pittsburgh Sleep Quality Index, where a lower score (0-21), better sleep quality. Follows a continuous metric scale.

Secondary

MeasureTime frameDescription
Epworth sleepiness scaleAt the beginning, every two weeks up to 12 weeksThe Epworth Sleepiness Scale, where a lower score (0-24), better sleep. Follows a continuous metric scale.
Sleep scale (medical outcomes study)At the beginning, every two weeks up to 12 weeksThe 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.
Visual analog scaleAt the beginning, every two weeks up to 12 weeksThe 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.
Fibromyalgia impact questionnaireAt the beginning, every two weeks up to 12 weeksThe Fibromyalgia Impact Questionnaire follows a continuous metric scale, (0-100), where a higher score means lower quality of life.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026