Effectiveness of Dance Therapy in Fibromyalgia.
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dance therapy
Educational group
Sponsored by
About this trial
This is an interventional prevention trial for Fibromyalgia focused on measuring Balance, Pain, TUG, Dance
Eligibility Criteria
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.
Sites / Locations
- University of Granada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DanceTherapy Group
Control Group
Arm Description
The experimental group will receive a dance treatment.
The control group will be subjected to a educational treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
SLUMP Test
Change from de baseline in the movement of the pain-sensitive nerve structures.
Straight Leg Raise test (SLR)
Change from de baseline in the movement of the pain-sensitive nerve structures.
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.
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.
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.
Athens Insomnia Scale (AIS)
Change from the baseline on insomnia. It is a self-rating instrument of eigth items.
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.
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.
Epworth Sleepiness Scale, (EES)
Change from thebaseline of the subject's general level of daytime sleepiness.
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.
Full Information
NCT ID
NCT03971890
First Posted
May 31, 2019
Last Updated
September 28, 2019
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT03971890
Brief Title
Effectiveness of Dance Therapy in Fibromyalgia.
Official Title
Effectiveness of a Exercise Program Based on Dance Therapy in Fibromyalgia: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
September 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Balance, Pain, TUG, Dance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DanceTherapy Group
Arm Type
Experimental
Arm Description
The experimental group will receive a dance treatment.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
The control group will be subjected to a educational treatment.
Intervention Type
Other
Intervention Name(s)
Dance therapy
Other Intervention Name(s)
Exercise treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational group
Other Intervention Name(s)
Control group
Intervention Description
The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
One leg stance
Description
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.
Time Frame
8 weeks
Title
SLUMP Test
Description
Change from de baseline in the movement of the pain-sensitive nerve structures.
Time Frame
8 weeks
Title
Straight Leg Raise test (SLR)
Description
Change from de baseline in the movement of the pain-sensitive nerve structures.
Time Frame
8 weeks
Title
Revised Fibromyalgia Impact Questionnaire (FIQR)
Description
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.
Time Frame
8 weeks
Title
Sheehan Disability Scale (SDS)
Description
Change from the baseline on the severity of general disability in the items of work, family life/home responsibilities and social life/leisure activities.
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
8 weeks
Title
Athens Insomnia Scale (AIS)
Description
Change from the baseline on insomnia. It is a self-rating instrument of eigth items.
Time Frame
8 weeks
Title
Spanish version of the Brief Pain Inventory questionnaire (CBD)
Description
Change from the baseline on the intensity of pain and its impact on activities of daily living.
Time Frame
8 weeks
Title
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Description
Change from the baseline on physical disability related to activities of eight categories of daily living over the last week.
Time Frame
8 weeks
Title
Epworth Sleepiness Scale, (EES)
Description
Change from thebaseline of the subject's general level of daytime sleepiness.
Time Frame
8 weeks
Title
Minibestest
Description
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.
Time Frame
8 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18001
Country
Spain
12. IPD Sharing Statement
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Effectiveness of Dance Therapy in Fibromyalgia.
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