Pilates Exercises in Spanish Women With Fibromyalgia

NCT03318458 | Completed

• 1 other identifier: Jaen University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fall Due to Loss of Equilibrium

Outcome Measures

Primary Outcomes (36)

• Dynamometer

  Dynamometer will be employed to assess hand grip stregth

  At the beginning and at three months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Bone Mineral Content (BMC)

  Is mineral mass in bone

  At the beginning and at three months

• 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

• 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

• Lean Body Mass

  The amount of lean body mass

  At the beginning and at three months

• 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

• Percent of Body Fat (%)

  Indicates the percentage of body fat to body weight

  At the beginning and at three months

• 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

• 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

• 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

• CT10P

  Test that evaluates the balance by walking along a straight line

  At the beginning and at three months

• 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

• 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

• X mean

  Mean value of the lateral oscillations of the Pressure Center

  At the beginning and at three months

• Y mean

  Mean value of the anteroposterior oscillations of the Pressure Center

  At the beginning and at three months

• RMS X

  Mean position of the center of pressure in the mediolateral plane

  At the beginning and at three months

• Length

  Length of the path described by the center of pressure

  At the beginning and at three months

• Area

  Area of the path described by the center of pressure

  At the beginning and at three months

• 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

• Chair Sit and Reach Test

  To test low back and hamstring flexibility

  At the beginning and at three months

• Back Scratch Test

  To measure general shoulder range of motion

  At the beginning and at three months

• 30-Second Chair Stand Test

  To test leg strength and endurance

  At the beginning and at three months

• Height

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

  At the beginning and at three months

• Wais Circumference

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

  At the beginning and at three months

• Hip Circumference

  It is the greatest circumference of hip

  At the beginning and at three months

• 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

Study Arms (2)

Pilates group

EXPERIMENTAL

Other: Pilates

No intervention group

NO INTERVENTION

Interventions

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

Pilates group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

AFIXA

Jaén, 23009, Spain

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes. All measurements given above will be made both to the control group and to the experimental group just prior to the start of the intervention, and immediately after and six months after the end of this period, and the results will be recorded in a data record
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 24, 2017
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

ES (1)