Effectiveness of Dance Therapy in Fibromyalgia.

Sponsor

Universidad de Granada (Other)

Overall Status

Completed

CT.gov ID

NCT03971890

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Other: Dance therapy Other: Educational group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 22, 2019

Actual Primary Completion Date :

Aug 21, 2019

Actual Study Completion Date :

Sep 21, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Timed Up and Go (TUG) [8 weeks]
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.

Secondary Outcome Measures

One leg stance [8 weeks]
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.
SLUMP Test [8 weeks]
Change from de baseline in the movement of the pain-sensitive nerve structures.
Straight Leg Raise test (SLR) [8 weeks]
Change from de baseline in the movement of the pain-sensitive nerve structures.
Revised Fibromyalgia Impact Questionnaire (FIQR) [8 weeks]
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.
Sheehan Disability Scale (SDS) [8 weeks]
Change from the baseline on the severity of general disability in the items of work, family life/home responsibilities and social life/leisure activities.
Pittsburgh Sleep Quality Index (PSQI) [8 weeks]
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.
Athens Insomnia Scale (AIS) [8 weeks]
Change from the baseline on insomnia. It is a self-rating instrument of eigth items.
Spanish version of the Brief Pain Inventory questionnaire (CBD) [8 weeks]
Change from the baseline on the intensity of pain and its impact on activities of daily living.
Health Assessment Questionnaire - Disability Index (HAQ-DI) [8 weeks]
Change from the baseline on physical disability related to activities of eight categories of daily living over the last week.
Epworth Sleepiness Scale, (EES) [8 weeks]
Change from thebaseline of the subject's general level of daytime sleepiness.
Minibestest [8 Weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.