NCT02876965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

August 14, 2016

Last Update Submit

November 7, 2019

Conditions

FibromyalgiaSleepStretch

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Epworth sleepiness scale

    At the beginning, every two weeks up to 12 weeks

  • Sleep scale (medical outcomes study)

    At the beginning, every two weeks up to 12 weeks

  • Visual analog scale

    At the beginning, every two weeks up to 12 weeks

  • Fibromyalgia impact questionnaire

    At the beginning, every two weeks up to 12 weeks

Study Arms (2)

Physical Exercise

ACTIVE COMPARATOR

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.

Procedure: Physical Exercise

Muscle Stretching

EXPERIMENTAL

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

Procedure: Muscle StretchingProcedure: Physical Exercise

Interventions

Muscle StretchingPROCEDURE

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

Muscle Stretching
Physical ExercisePROCEDURE

Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.

Muscle StretchingPhysical Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEU Cardenal Herrera University

Moncada, Valencia, 46113, Spain

Location

Related Publications (10)

  • 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.

    PMID: 2306288RESULT

  • 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.

    PMID: 20461783RESULT

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

    PMID: 19962494RESULT

  • 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.

    PMID: 19473857RESULT

  • 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.

    PMID: 17149057RESULT

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

    PMID: 19935069RESULT

  • 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.

    PMID: 18323770RESULT

  • 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.

    PMID: 16575859RESULT

  • 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.

    PMID: 16999856RESULT

  • Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.

    PMID: 17943797RESULT

MeSH Terms

Conditions

Fibromyalgia

Interventions

Muscle Stretching ExercisesExercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • F Javier Montañez-Aguilera, PhD

    CEU Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 14, 2016

First Posted

August 24, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)