Clinical trial NCT03318458: Pilates Exercises in Spanish Women With Fibromyalgia
Official title: Effects of a Program of Pilates Exercises in Spanish Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Due to Loss of Equilibrium
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To analyze the effects of a Pilates exercise program in Spanish postmenopausal women with Fibromyalgia

Detailed description: This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.

The study will define two groups:

* A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
* An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.

Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Eligibility criteria: Inclusion Criteria:

* No menstrual activity for at least 12 months.
* Present Fibromyalgia.
* Do not participate in a weight loss program.
* Be able to understand the instructions, programs and protocols of this project.

Exclusion Criteria:

* Contraindications for conducting physical tests.
* Diseases that limit the static and dynamic balance and physical activity. -
* Central or peripheral vestibular or nerve alterations.

Primary outcomes:
measure: Dynamometer
timeFrame: At the beginning and at three months
measure: ABC-16 (Activities Specific Balance Confidence Scale)
timeFrame: At the beginning and at three months
measure: FES-I (Falls Efficacy Scale-International)
timeFrame: At the beginning and at three months
measure: FSS (Fatigue Severity Scale)
timeFrame: At the beginning and at three months
measure: FIQ (Fybromialgia Impact Questionnaire)
timeFrame: At the beginning and at three months
measure: VAS-Fatigue
timeFrame: At the beginning and at three months
measure: VAS-pain
timeFrame: At the beginning and at three months
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: At the beginning and at three months
measure: HADS (The Hospital Anxiety And Depression)
timeFrame: At the beginning and at three months
measure: SF-36 (The Short Form-36 Health Survey)
timeFrame: At the beginning and at three months
measure: INBODY
timeFrame: At the beginning and at three months
measure: Bone Mineral Content (BMC)
timeFrame: At the beginning and at three months
measure: Body Weight: is the sum of Body Fat and Fat Free Mass.
timeFrame: At the beginning and at three months
measure: Skeletal Muscle Mass (kg)
timeFrame: At the beginning and at three months
measure: Lean Body Mass
timeFrame: At the beginning and at three months
measure: Body Fat Mass
timeFrame: At the beginning and at three months
measure: Percent of Body Fat (%)
timeFrame: At the beginning and at three months
measure: BMI (Body Mass Index)
timeFrame: At the beginning and at three months
measure: Segmental Analysis
timeFrame: At the beginning and at three months
measure: TUG (Timed Up and Go test)
timeFrame: At the beginning and at three months
measure: CT10P
timeFrame: At the beginning and at three months
measure: MRS (Menopause Rating Scale)
timeFrame: At the beginning and at three months
measure: STABILOMETRIC PLATFORM
timeFrame: At the beginning and at three months
measure: X mean
timeFrame: At the beginning and at three months
measure: Y mean
timeFrame: At the beginning and at three months
measure: RMS X
timeFrame: At the beginning and at three months
measure: Length
timeFrame: At the beginning and at three months
measure: Area
timeFrame: At the beginning and at three months
measure: Velocity
timeFrame: At the beginning and at three months
measure: Chair Sit and Reach Test
timeFrame: At the beginning and at three months
measure: Back Scratch Test
timeFrame: At the beginning and at three months
measure: 30-Second Chair Stand Test
timeFrame: At the beginning and at three months
measure: Height
timeFrame: At the beginning and at three months
measure: Wais Circumference
timeFrame: At the beginning and at three months
measure: Hip Circumference
timeFrame: At the beginning and at three months
measure: Waist-To-Hip Ratio
timeFrame: At the beginning and at three months
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: AFIXA
Study officials:
References: