NCT03971890

Brief Summary

The purpose of this study is to analyze the effects of an intervention with dance on balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control group that will have an educational intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

May 31, 2019

Last Update Submit

September 28, 2019

Conditions

Keywords

BalancePainTUGDance

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go (TUG)

    Change from de baseline in functional mobility and predict risk of falls. The single-task subscale consists of a measurement of the time in seconds for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The dual task subscale adds a cognitive task (TUGCognitive) or a manual task (TUGManual) to the simple task.

    8 weeks

Secondary Outcomes (11)

  • One leg stance

    8 weeks

  • SLUMP Test

    8 weeks

  • Straight Leg Raise test (SLR)

    8 weeks

  • Revised Fibromyalgia Impact Questionnaire (FIQR)

    8 weeks

  • Sheehan Disability Scale (SDS)

    8 weeks

  • +6 more secondary outcomes

Study Arms (2)

DanceTherapy Group

EXPERIMENTAL

The experimental group will receive a dance treatment.

Other: Dance therapy

Control Group

EXPERIMENTAL

The control group will be subjected to a educational treatment.

Other: Educational group

Interventions

The experimental group will receive a dance treatment.This protocol will be administered at weekly sessions of 60 minutes with a period of 2 times / week with a total of 16 sessions, distributed over a 8-week period. They will be evaluated at baseline, after the end of the last treatment session.

Also known as: Exercise treatment
DanceTherapy Group

The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.

Also known as: Control group
Control Group

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being over 18 years of age until 64.
  • Being diagnosed with FMS in accordance with American College of Rheumatology - ACR

You may not qualify if:

  • Participants with diagnoses of other inflammatory rheumatic diseases, previous neurological or orthopedic diseases,
  • Use aids for balance, hearing and visual problems.
  • Cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18001, Spain

Location

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Dance TherapyControl Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CareExercise Movement TechniquesPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research and teaching staff of the University of Granada

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 3, 2019

Study Start

April 22, 2019

Primary Completion

August 21, 2019

Study Completion

September 21, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations