Effectiveness of Dance Therapy in Fibromyalgia.

Effectiveness of a Exercise Program Based on Dance Therapy in Fibromyalgia: A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Dance therapy; Other: Educational group

Detailed Description

Fibromyalgia is a chronic disease consisting of widespread pain, fatigue, sleep disturbances, and cognitive impairments, among other symptoms, which affect daily physical activity.

The regular physical exercise improves the functional, physiological, and behavioral components of physical fitness. Dance therapy seems to increase motivation and adherence to therapy, and can provide a real alternative to conventional exercise

The experimental group will receive a dance program treatment .

The control group will receive an educational intervention.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18001
    • University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DanceTherapy Group; The experimental group will receive a dance treatment.	Other: Dance therapy; 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.; Other Names: Exercise treatment
EXPERIMENTAL: Control Group; The control group will be subjected to a educational treatment.	Other: Educational group; The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
One leg stance	Change from de baseline in postural steadiness (static balance) in a static position by registering the number of seconds a person can maintain this position.	8 weeks
SLUMP Test	Change from de baseline in the movement of the pain-sensitive nerve structures.	8 weeks
Straight Leg Raise test (SLR)	Change from de baseline in the movement of the pain-sensitive nerve structures.	8 weeks
Revised Fibromyalgia Impact Questionnaire (FIQR)	Change from the baseline on the impact of symptoms on quality of life in people with fibromyalgia. Questionnaire with 21-items on a visual analogue scale.	8 weeks
Sheehan Disability Scale (SDS)	Change from the baseline on the severity of general disability in the items of work, family life/home responsibilities and social life/leisure activities.	8 weeks
Pittsburgh Sleep Quality Index (PSQI)	change from the baseline on sleep quality. The self-rated items of the PSQI generate seven component scores (with subscales ranged 0-3): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction.	8 weeks
Athens Insomnia Scale (AIS)	Change from the baseline on insomnia. It is a self-rating instrument of eigth items.	8 weeks
Spanish version of the Brief Pain Inventory questionnaire (CBD)	Change from the baseline on the intensity of pain and its impact on activities of daily living.	8 weeks
Health Assessment Questionnaire - Disability Index (HAQ-DI)	Change from the baseline on physical disability related to activities of eight categories of daily living over the last week.	8 weeks
Epworth Sleepiness Scale, (EES)	Change from thebaseline of the subject's general level of daytime sleepiness.	8 weeks
Minibestest	Change from baseline in Dynamic Balance: areas are anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability in gait. This tool has 14 items, with a maximum score of 28 points.	8 Weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2019
• Primary Completion (ACTUAL): August 21, 2019
• Study Completion (ACTUAL): September 21, 2019

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (ACTUAL): June 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Balance; Pain; Dance; TUG
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: ExerFib

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No