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

NCT ID: NCT02876965

Last Updated: 2019-11-08

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia Sleep Stretch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Physical Exercise

Intervention Type PROCEDURE

Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.

Muscle Stretching

Stretching program on the main muscle groups of the body, for 12 weeks, 1sessions per week, about 45 minutes.

Group Type EXPERIMENTAL

Muscle Stretching

Intervention Type PROCEDURE

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

Physical Exercise

Intervention Type PROCEDURE

Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.

Interventions

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Muscle Stretching

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

Intervention Type PROCEDURE

Physical Exercise

Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Fco. Javier Montanez Aguilera

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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F Javier MontaƱez-Aguilera, PhD

Role: PRINCIPAL_INVESTIGATOR

CEU Cardenal Herrera University

Locations

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CEU Cardenal Herrera University

Moncada, Valencia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 2306288 (View on PubMed)

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.

Reference Type RESULT
PMID: 20461783 (View on PubMed)

Clauw DJ. Fibromyalgia: an overview. Am J Med. 2009 Dec;122(12 Suppl):S3-S13. doi: 10.1016/j.amjmed.2009.09.006.

Reference Type RESULT
PMID: 19962494 (View on PubMed)

Gormsen L, Rosenberg R, Bach FW, Jensen TS. Depression, anxiety, health-related quality of life and pain in patients with chronic fibromyalgia and neuropathic pain. Eur J Pain. 2010 Feb;14(2):127.e1-8. doi: 10.1016/j.ejpain.2009.03.010. Epub 2009 May 26.

Reference Type RESULT
PMID: 19473857 (View on PubMed)

Shah MA, Feinberg S, Krishnan E. Sleep-disordered breathing among women with fibromyalgia syndrome. J Clin Rheumatol. 2006 Dec;12(6):277-81. doi: 10.1097/01.rhu.0000249771.97221.36.

Reference Type RESULT
PMID: 17149057 (View on PubMed)

Moldofsky H. Rheumatic manifestations of sleep disorders. Curr Opin Rheumatol. 2010 Jan;22(1):59-63. doi: 10.1097/BOR.0b013e328333b9cc.

Reference Type RESULT
PMID: 19935069 (View on PubMed)

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.

Reference Type RESULT
PMID: 18323770 (View on PubMed)

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.

Reference Type RESULT
PMID: 16575859 (View on PubMed)

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.

Reference Type RESULT
PMID: 16999856 (View on PubMed)

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.

Reference Type RESULT
PMID: 17943797 (View on PubMed)

Other Identifiers

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CEU-UCH

Identifier Type: -

Identifier Source: org_study_id

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