Effectiveness of Dance Therapy in Fibromyalgia.

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971890
• Other study ID #: ExerFib
• Status: Completed
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: September 21, 2019

Study information

• Verified date: September 2019
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 21, 2019
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	SLUMP Test	Change from de baseline in the movement of the pain-sensitive nerve structures.	8 weeks
Secondary	Straight Leg Raise test (SLR)	Change from de baseline in the movement of the pain-sensitive nerve structures.	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Athens Insomnia Scale (AIS)	Change from the baseline on insomnia. It is a self-rating instrument of eigth items.	8 weeks
Secondary	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
Secondary	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
Secondary	Epworth Sleepiness Scale, (EES)	Change from thebaseline of the subject's general level of daytime sleepiness.	8 weeks
Secondary	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