Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Protocol Based on Physical Exercise and Stretching
Primary Purpose
Fibromyalgia, Sleep, Stretch
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Muscle Stretching
Physical Exercise
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- CEU Cardenal Herrera University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physical Exercise
Muscle Stretching
Arm Description
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.
Stretching program on the main muscle groups of the body, for 12 weeks, 1sessions per week, about 45 minutes.
Outcomes
Primary Outcome Measures
Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index, where a lower score (0-21), better sleep quality. Follows a continuous metric scale.
Secondary Outcome Measures
Epworth sleepiness scale
The Epworth Sleepiness Scale, where a lower score (0-24), better sleep. Follows a continuous metric scale.
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.
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.
Fibromyalgia impact questionnaire
The Fibromyalgia Impact Questionnaire follows a continuous metric scale, (0-100), where a higher score means lower quality of life.
Full Information
NCT ID
NCT02876965
First Posted
August 14, 2016
Last Updated
November 7, 2019
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT02876965
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Sleep, Stretch
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Muscle Stretching
Arm Type
Experimental
Arm Description
Stretching program on the main muscle groups of the body, for 12 weeks, 1sessions per week, about 45 minutes.
Intervention Type
Procedure
Intervention Name(s)
Muscle Stretching
Intervention Description
Subjects completed one stretching session on the main muscle groups of the body weekly.
Intervention Type
Procedure
Intervention Name(s)
Physical Exercise
Intervention Description
Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index
Description
The Pittsburgh Sleep Quality Index, where a lower score (0-21), better sleep quality. Follows a continuous metric scale.
Time Frame
At the beginning, every two weeks up to 12 weeks
Secondary Outcome Measure Information:
Title
Epworth sleepiness scale
Description
The Epworth Sleepiness Scale, where a lower score (0-24), better sleep. Follows a continuous metric scale.
Time Frame
At the beginning, every two weeks up to 12 weeks
Title
Sleep scale (medical outcomes study)
Description
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.
Time Frame
At the beginning, every two weeks up to 12 weeks
Title
Visual analog scale
Description
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.
Time Frame
At the beginning, every two weeks up to 12 weeks
Title
Fibromyalgia impact questionnaire
Description
The Fibromyalgia Impact Questionnaire follows a continuous metric scale, (0-100), where a higher score means lower quality of life.
Time Frame
At the beginning, every two weeks up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F Javier Montañez-Aguilera, PhD
Organizational Affiliation
CEU Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEU Cardenal Herrera University
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
2306288
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.
Results Reference
result
PubMed Identifier
20461783
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.
Results Reference
result
PubMed Identifier
19962494
Citation
Clauw DJ. Fibromyalgia: an overview. Am J Med. 2009 Dec;122(12 Suppl):S3-S13. doi: 10.1016/j.amjmed.2009.09.006.
Results Reference
result
PubMed Identifier
19473857
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.
Results Reference
result
PubMed Identifier
17149057
Citation
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.
Results Reference
result
PubMed Identifier
19935069
Citation
Moldofsky H. Rheumatic manifestations of sleep disorders. Curr Opin Rheumatol. 2010 Jan;22(1):59-63. doi: 10.1097/BOR.0b013e328333b9cc.
Results Reference
result
PubMed Identifier
18323770
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.
Results Reference
result
PubMed Identifier
16575859
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.
Results Reference
result
PubMed Identifier
16999856
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.
Results Reference
result
PubMed Identifier
17943797
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.
Results Reference
result
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Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Protocol Based on Physical Exercise and Stretching
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