Clinical trial NCT02876965: Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Protocol Based on Physical Exercise and Stretching
Official title: Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Combined Protocol Based on Physical Exercise and Muscle Stretching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Sleep
Stretch
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: At the beginning, every two weeks up to 12 weeks
Secondary outcomes:
measure: Epworth sleepiness scale
timeFrame: At the beginning, every two weeks up to 12 weeks
measure: Sleep scale (medical outcomes study)
timeFrame: At the beginning, every two weeks up to 12 weeks
measure: Visual analog scale
timeFrame: At the beginning, every two weeks up to 12 weeks
measure: Fibromyalgia impact questionnaire
timeFrame: At the beginning, every two weeks up to 12 weeks
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: CEU Cardenal Herrera University
state: Valencia
Study officials:
affiliation: CEU Cardenal Herrera University
name: F Javier Montañez-Aguilera, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
citation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
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citation: Moldofsky H. Rheumatic manifestations of sleep disorders. Curr Opin Rheumatol. 2010 Jan;22(1):59-63. doi: 10.1097/BOR.0b013e328333b9cc.
citation: Moldofsky H. The significance, assessment, and management of nonrestorative sleep in fibromyalgia syndrome. CNS Spectr. 2008 Mar;13(3 Suppl 5):22-6. doi: 10.1017/s1092852900026808.
citation: Valkeinen H, Hakkinen A, Hannonen P, Hakkinen K, Alen M. Acute heavy-resistance exercise-induced pain and neuromuscular fatigue in elderly women with fibromyalgia and in healthy controls: effects of strength training. Arthritis Rheum. 2006 Apr;54(4):1334-9. doi: 10.1002/art.21751.
citation: Jones KD, Adams D, Winters-Stone K, Burckhardt CS. A comprehensive review of 46 exercise treatment studies in fibromyalgia (1988-2005). Health Qual Life Outcomes. 2006 Sep 25;4:67. doi: 10.1186/1477-7525-4-67.
citation: Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.