Pilates Exercises in Spanish Women With Fibromyalgia

Fall Due to Loss of Equilibrium Clinical Trial

Official title:

Effects of a Program of Pilates Exercises in Spanish Women With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318458
• Other study ID #: Jaen University
• Status: Completed
• Phase: N/A
• First received: October 3, 2017
• Last updated: December 5, 2017
• Start date: September 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: December 2017
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall Due to Loss of Equilibrium
• Fibromyalgia

Intervention

Other:
• Pilates
The duration of the intervention is 12 weeks, with 2 sessions per week of Pilates. Each session lasts approximately 1 hour and is structured in three parts: initial warm-up, which reviews the basic principles of the Pilates Method (centralization, concentration, movement control, breathing, movement precision and fluency) of 10 minutes duration, a 40-45 minute Pilates session and finally 10 minutes of guided relaxation. No complement was used (magic rings, fitball, elastic bands, etc.) during classes

Locations

Country	Name	City	State
Spain	AFIXA	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamometer	Dynamometer will be employed to assess hand grip stregth	At the beginning and at three months
Primary	ABC-16 (Activities Specific Balance Confidence Scale)	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.	At the beginning and at three months
Primary	FES-I (Falls Efficacy Scale-International)	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.	At the beginning and at three months
Primary	FSS (Fatigue Severity Scale)	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.	At the beginning and at three months
Primary	FIQ (Fybromialgia Impact Questionnaire)	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.	At the beginning and at three months
Primary	VAS-Fatigue	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.	At the beginning and at three months
Primary	VAS-pain	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.	At the beginning and at three months
Primary	PSQI (Pittsburgh Sleep Quality Index)	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.	At the beginning and at three months
Primary	HADS (The Hospital Anxiety And Depression)	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.	At the beginning and at three months
Primary	SF-36 (The Short Form-36 Health Survey)	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.	At the beginning and at three months
Primary	INBODY	Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat	At the beginning and at three months
Primary	Bone Mineral Content (BMC)	Is mineral mass in bone	At the beginning and at three months
Primary	Body Weight: is the sum of Body Fat and Fat Free Mass.	Is the sum of Body Fat and Fat Free Mass	At the beginning and at three months
Primary	Skeletal Muscle Mass (kg)	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	At the beginning and at three months
Primary	Lean Body Mass	The amount of lean body mass	At the beginning and at three months
Primary	Body Fat Mass	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	At the beginning and at three months
Primary	Percent of Body Fat (%)	Indicates the percentage of body fat to body weight	At the beginning and at three months
Primary	BMI (Body Mass Index)	Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat	At the beginning and at three months
Primary	Segmental Analysis	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	At the beginning and at three months
Primary	TUG (Timed Up and Go test)	Is a simple test used to assess a person's mobility and physical function	At the beginning and at three months
Primary	CT10P	Test that evaluates the balance by walking along a straight line	At the beginning and at three months
Primary	MRS (Menopause Rating Scale)	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.	At the beginning and at three months
Primary	STABILOMETRIC PLATFORM	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	At the beginning and at three months
Primary	X mean	Mean value of the lateral oscillations of the Pressure Center	At the beginning and at three months
Primary	Y mean	Mean value of the anteroposterior oscillations of the Pressure Center	At the beginning and at three months
Primary	RMS X	Mean position of the center of pressure in the mediolateral plane	At the beginning and at three months
Primary	Length	Length of the path described by the center of pressure	At the beginning and at three months
Primary	Area	Area of the path described by the center of pressure	At the beginning and at three months
Primary	Velocity	Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test	At the beginning and at three months
Primary	Chair Sit and Reach Test	To test low back and hamstring flexibility	At the beginning and at three months
Primary	Back Scratch Test	To measure general shoulder range of motion	At the beginning and at three months
Primary	30-Second Chair Stand Test	To test leg strength and endurance	At the beginning and at three months
Primary	Height	The distance between the lowest and highest points of a person standing upright	At the beginning and at three months
Primary	Wais Circumference	Is used to assess central fat distribution and degree of abdominal obesity	At the beginning and at three months
Primary	Hip Circumference	It is the greatest circumference of hip	At the beginning and at three months
Primary	Waist-To-Hip Ratio	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	At the beginning and at three months