Pilates Exercises in Spanish Women With Fibromyalgia
- Conditions
- Fall Due to Loss of Equilibrium
- Interventions
- Other: Pilates
- Registration Number
- NCT03318458
- Lead Sponsor
- University of Jaén
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- 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.
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pilates group Pilates -
- Primary Outcome Measures
Name Time Method ABC-16 (Activities Specific Balance Confidence Scale) At the beginning and at three months Questionnaire that assesses balance confidence in performing activities of daily living. It is calculated by adding up the 16 responses of the questionnaire, with 0 being the minimum score and 100 being the maximum score. The higher value represents a better result.
FES-I (Falls Efficacy Scale-International) At the beginning and at three months Questionnaire that evaluates the fear of falling. It is calculated by adding up all the answers in the questionnaire, 16 being the minimum score and 64 the maximum score. The higher value represents a worse result.
Bone Mineral Content (BMC) At the beginning and at three months Is mineral mass in bone
Y mean At the beginning and at three months Mean value of the anteroposterior oscillations of the Pressure Center
Percent of Body Fat (%) At the beginning and at three months Indicates the percentage of body fat to body weight
VAS-Fatigue At the beginning and at three months Fatigue assessed by a Visual Analogue Scale (10 cm). The patient marks the intensity of the fatigue on a numerical scale of 0-10, with 0 being the minimum score and 10 being the maximum score. The higher value represents a worse result.
PSQI (Pittsburgh Sleep Quality Index) At the beginning and at three months A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result.
Body Weight: is the sum of Body Fat and Fat Free Mass. At the beginning and at three months Is the sum of Body Fat and Fat Free Mass
Body Fat Mass At the beginning and at three months The standard range of Body Fat Mass is ascertained by calculating an examinee Body Fat Mass as compared to the standard weight and standard Body Fat Mass
FSS (Fatigue Severity Scale) At the beginning and at three months A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living. It is calculated by adding up the 9 answers of the questionnaire, being 9 the minimum score and 63 the maximum score. The higher value represents a worse result.
FIQ (Fybromialgia Impact Questionnaire) At the beginning and at three months A questionnarie that evaluates the impact of fibromyalgia on the patient's quality of life.The total score is the addition of the scores of all its sections. In the case that there were left some unanswered, all the other ones are added up and the score is divided by the number of items answered and multiplied by 10, with the result that the final score of the FIQ is from 0 to 100. A higher score means a greater impact of the disease on the patient.
HADS (The Hospital Anxiety And Depression) At the beginning and at three months A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non- patients. It is calculated by the sum of the 14 questions in the questionnaire divided into two subscales: anxiety (questions 1, 3, 5, 7, 9, 11, 13) and depression (questions 2, 4, 6, 8, 10, 12, 14). The higher value represents a worse result.
Dynamometer At the beginning and at three months Dynamometer will be employed to assess hand grip stregth
VAS-pain At the beginning and at three months Pain assessed by a Visual Analogue Scale (10 cm). The patient on a numerical scale of 0-10 marks the intensity of the pain, with 0 being the minimum score and 10 the maximum score. The higher value represents a worse result.
INBODY At the beginning and at three months Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat
SF-36 (The Short Form-36 Health Survey) At the beginning and at three months Used extensively for assessing health-related quality of life. It is calculated by adding the 36 questionnaires divided into 9 subscales: general health, health change, physical function, physical role, role or emotional performance, social function, physical or body pain, vitality and mental health. Each item is rated 0-1-2-3-4 points with 0 being the best score.
Skeletal Muscle Mass (kg) At the beginning and at three months Is computed based on muscle mass of the limbs, which is almost composed of skeletal muscle and takes up about 70% of total body skeletal muscle
CT10P At the beginning and at three months Test that evaluates the balance by walking along a straight line
MRS (Menopause Rating Scale) At the beginning and at three months assesses the severity of menopause-related complaints and the impact on health-related quality of life. Calculated by adding up the 11 questions in the questionnaire. Each item has a score of 0-1-2-3-4, with 4 being the worst score.
Lean Body Mass At the beginning and at three months The amount of lean body mass
Velocity At the beginning and at three months Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test
Chair Sit and Reach Test At the beginning and at three months To test low back and hamstring flexibility
BMI (Body Mass Index) At the beginning and at three months Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat
TUG (Timed Up and Go test) At the beginning and at three months Is a simple test used to assess a person's mobility and physical function
X mean At the beginning and at three months Mean value of the lateral oscillations of the Pressure Center
Segmental Analysis At the beginning and at three months Is the technology that assumes the body as five cylinders of four limbs and trunk and measures the impedance of these parts separately. Segmental body composition analysis provides segmental measurement of body water, muscle mass, and fat free mass
RMS X At the beginning and at three months Mean position of the center of pressure in the mediolateral plane
STABILOMETRIC PLATFORM At the beginning and at three months instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions
Length At the beginning and at three months Length of the path described by the center of pressure
Area At the beginning and at three months Area of the path described by the center of pressure
Height At the beginning and at three months The distance between the lowest and highest points of a person standing upright
30-Second Chair Stand Test At the beginning and at three months To test leg strength and endurance
Wais Circumference At the beginning and at three months Is used to assess central fat distribution and degree of abdominal obesity
Back Scratch Test At the beginning and at three months To measure general shoulder range of motion
Hip Circumference At the beginning and at three months It is the greatest circumference of hip
Waist-To-Hip Ratio At the beginning and at three months Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AFIXA
🇪🇸Jaén, Spain