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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876965
• Other study ID #: CEU-UCH
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2019
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Sleep
• Stretch

Intervention

Procedure:
• Muscle Stretching
Subjects completed one stretching session on the main muscle groups of the body weekly.
• Physical Exercise
Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.

Locations

Country	Name	City	State
Spain	CEU Cardenal Herrera University	Moncada	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. Review. — View Citation

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

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. — View 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. Review. — View Citation

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

Moldofsky H. The significance, assessment, and management of nonrestorative sleep in fibromyalgia syndrome. CNS Spectr. 2008 Mar;13(3 Suppl 5):22-6. Review. — View Citation

Shah MA, Feinberg S, Krishnan E. Sleep-disordered breathing among women with fibromyalgia syndrome. J Clin Rheumatol. 2006 Dec;12(6):277-81. — View Citation

Valkeinen H, Häkkinen A, Hannonen P, Häkkinen K, Alén 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- — View 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 Re — View 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 Committe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh sleep quality index	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	Epworth sleepiness scale	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
Secondary	Sleep scale (medical outcomes study)	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
Secondary	Visual analog scale	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
Secondary	Fibromyalgia impact questionnaire	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