Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 39 of 96 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Cardenal Herrera University
Sponsor:
Information provided by (Responsible Party):
Fco. Javier Montanez Aguilera, Cardenal Herrera University
ClinicalTrials.gov Identifier:
NCT02876965
First received: August 14, 2016
Last updated: August 19, 2016
Last verified: August 2016
  Purpose
This study evaluates the effect to a muscle stretching program combined with physical exercise versus a physical exercise program in patients with fibromyalgia.

Condition Intervention Phase
Fibromyalgia
Sleep
Stretch
Procedure: Muscle Stretching
Procedure: Physical Exercise
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Combined Protocol Based on Physical Exercise and Muscle Stretching

Resource links provided by NLM:


Further study details as provided by Cardenal Herrera University:

Primary Outcome Measures:
  • Pittsburgh sleep quality index [ Time Frame: At the beginning, every two weeks up to 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the beginning, every two weeks up to 24 weeks ] [ Designated as safety issue: No ]
    The Epworth Sleepiness Scale, where a lower score (0-24), better sleep. Follows a continuous metric scale.

  • Sleep scale (medical outcomes study) [ Time Frame: At the beginning, every two weeks up to 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the beginning, every two weeks up to 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the beginning, every two weeks up to 24 weeks ] [ Designated as safety issue: No ]
    The Fibromyalgia Impact Questionnaire follows a continuous metric scale, (0-100), where a higher score means lower quality of life.


Estimated Enrollment: 40
Study Start Date: August 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physical Exercise
Aerobic physical exercise protocol of moderate intensity, for 24 weeks, 3 sessions per week, about 12 minutes. Physical activity chosen will be pedaling on a static bike.
Procedure: Physical Exercise
Aerobic physical exercise program of moderate intensity
Experimental: Muscle Stretching
Stretching program at the end of the physical exercise on the main muscle groups of the body
Procedure: Muscle Stretching
Once the program of aerobic physical exercise of moderate intensity is completed, subjects will perform a program of stretching on the main muscle groups of the body
Procedure: Physical Exercise
Aerobic physical exercise program of moderate intensity

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02876965

Contacts
Contact: F Javier Montañez-Aguilera, PhD +34677560697 francisco.monta@uchceu.es

Locations
Spain
CEU Cardenal Herrera University Recruiting
Moncada, Valencia, Spain, 46113
Contact: F Javier Montañez-Aguilera, PhD    +34677560697    francisco.monta@uchceu.es   
Sponsors and Collaborators
Cardenal Herrera University
Investigators
Principal Investigator: F Javier Montañez-Aguilera, PhD CEU Cardenal Herrera University
  More Information

Publications:

Responsible Party: Fco. Javier Montanez Aguilera, PhD, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT02876965     History of Changes
Other Study ID Numbers: CEU-UCH 
Study First Received: August 14, 2016
Last Updated: August 19, 2016
Health Authority: Spain: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on December 08, 2016