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Completed

NCT Number: NCT03318458

Pilates Exercises in Spanish Women With Fibromyalgia

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

Completed

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AFIXA

Jaén, 23009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates

Other

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

Primary outcomes

  1. Dynamometer

    Time frame: At the beginning and at three months

    Dynamometer will be employed to assess hand grip stregth

  2. ABC-16 (Activities Specific Balance Confidence Scale)

    Time frame: 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.

  3. FES-I (Falls Efficacy Scale-International)

    Time frame: 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.

  4. FSS (Fatigue Severity Scale)

    Time frame: 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.

  5. FIQ (Fybromialgia Impact Questionnaire)

    Time frame: 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.

  6. VAS-Fatigue

    Time frame: 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.

  7. VAS-pain

    Time frame: 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.

  8. PSQI (Pittsburgh Sleep Quality Index)

    Time frame: 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.

  9. HADS (The Hospital Anxiety And Depression)

    Time frame: 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.

  10. SF-36 (The Short Form-36 Health Survey)

    Time frame: 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.

  11. INBODY

    Time frame: 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

  12. Bone Mineral Content (BMC)

    Time frame: At the beginning and at three months

    Is mineral mass in bone

  13. Body Weight: is the sum of Body Fat and Fat Free Mass.

    Time frame: At the beginning and at three months

    Is the sum of Body Fat and Fat Free Mass

  14. Skeletal Muscle Mass (kg)

    Time frame: 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

  15. Lean Body Mass

    Time frame: At the beginning and at three months

    The amount of lean body mass

  16. Body Fat Mass

    Time frame: 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

  17. Percent of Body Fat (%)

    Time frame: At the beginning and at three months

    Indicates the percentage of body fat to body weight

  18. BMI (Body Mass Index)

    Time frame: 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

  19. Segmental Analysis

    Time frame: 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

  20. TUG (Timed Up and Go test)

    Time frame: At the beginning and at three months

    Is a simple test used to assess a person's mobility and physical function

  21. CT10P

    Time frame: At the beginning and at three months

    Test that evaluates the balance by walking along a straight line

  22. MRS (Menopause Rating Scale)

    Time frame: 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.

  23. STABILOMETRIC PLATFORM

    Time frame: 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

  24. X mean

    Time frame: At the beginning and at three months

    Mean value of the lateral oscillations of the Pressure Center

  25. Y mean

    Time frame: At the beginning and at three months

    Mean value of the anteroposterior oscillations of the Pressure Center

  26. RMS X

    Time frame: At the beginning and at three months

    Mean position of the center of pressure in the mediolateral plane

  27. Length

    Time frame: At the beginning and at three months

    Length of the path described by the center of pressure

  28. Area

    Time frame: At the beginning and at three months

    Area of the path described by the center of pressure

  29. Velocity

    Time frame: 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

  30. Chair Sit and Reach Test

    Time frame: At the beginning and at three months

    To test low back and hamstring flexibility

  31. Back Scratch Test

    Time frame: At the beginning and at three months

    To measure general shoulder range of motion

  32. 30-Second Chair Stand Test

    Time frame: At the beginning and at three months

    To test leg strength and endurance

  33. Height

    Time frame: At the beginning and at three months

    The distance between the lowest and highest points of a person standing upright

  34. Wais Circumference

    Time frame: At the beginning and at three months

    Is used to assess central fat distribution and degree of abdominal obesity

  35. Hip Circumference

    Time frame: At the beginning and at three months

    It is the greatest circumference of hip

  36. Waist-To-Hip Ratio

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2017
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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