Effectiveness of Dance Therapy in Fibromyalgia.
Effectiveness of a Exercise Program Based on Dance Therapy in Fibromyalgia: A Randomized Controlled Trial.
1 other identifier
interventional
70
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2019
CompletedOctober 1, 2019
September 1, 2019
4 months
May 31, 2019
September 28, 2019
Conditions
Keywords
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
EXPERIMENTALThe experimental group will receive a dance treatment.
Control Group
EXPERIMENTALThe control group will be subjected to a educational treatment.
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.
The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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