Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT03318458
Status:
COMPLETED
Last Update Posted:
2017-12-07
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilates Exercises in Spanish Women With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.\n\nAll 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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-05', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamometer', 'timeFrame': 'At the beginning and at three months', 'description': 'Dynamometer will be employed to assess hand grip stregth'}, {'measure': 'ABC-16 (Activities Specific Balance Confidence Scale)', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'FES-I (Falls Efficacy Scale-International)', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'FSS (Fatigue Severity Scale)', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'FIQ (Fybromialgia Impact Questionnaire)', 'timeFrame': 'At the beginning and at three months', 'description': "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."}, {'measure': 'VAS-Fatigue', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'VAS-pain', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'PSQI (Pittsburgh Sleep Quality Index)', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'HADS (The Hospital Anxiety And Depression)', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'SF-36 (The Short Form-36 Health Survey)', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'INBODY', 'timeFrame': 'At the beginning and at three months', 'description': 'Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat'}, {'measure': 'Bone Mineral Content (BMC)', 'timeFrame': 'At the beginning and at three months', 'description': 'Is mineral mass in bone'}, {'measure': 'Body Weight: is the sum of Body Fat and Fat Free Mass.', 'timeFrame': 'At the beginning and at three months', 'description': 'Is the sum of Body Fat and Fat Free Mass'}, {'measure': 'Skeletal Muscle Mass (kg)', 'timeFrame': 'At the beginning and at three months', 'description': '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'}, {'measure': 'Lean Body Mass', 'timeFrame': 'At the beginning and at three months', 'description': 'The amount of lean body mass'}, {'measure': 'Body Fat Mass', 'timeFrame': 'At the beginning and at three months', 'description': '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'}, {'measure': 'Percent of Body Fat (%)', 'timeFrame': 'At the beginning and at three months', 'description': 'Indicates the percentage of body fat to body weight'}, {'measure': 'BMI (Body Mass Index)', 'timeFrame': 'At the beginning and at three months', 'description': 'Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat'}, {'measure': 'Segmental Analysis', 'timeFrame': 'At the beginning and at three months', 'description': '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'}, {'measure': 'TUG (Timed Up and Go test)', 'timeFrame': 'At the beginning and at three months', 'description': "Is a simple test used to assess a person's mobility and physical function"}, {'measure': 'CT10P', 'timeFrame': 'At the beginning and at three months', 'description': 'Test that evaluates the balance by walking along a straight line'}, {'measure': 'MRS (Menopause Rating Scale)', 'timeFrame': 'At the beginning and at three months', 'description': '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.'}, {'measure': 'STABILOMETRIC PLATFORM', 'timeFrame': 'At the beginning and at three months', 'description': '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'}, {'measure': 'X mean', 'timeFrame': 'At the beginning and at three months', 'description': 'Mean value of the lateral oscillations of the Pressure Center'}, {'measure': 'Y mean', 'timeFrame': 'At the beginning and at three months', 'description': 'Mean value of the anteroposterior oscillations of the Pressure Center'}, {'measure': 'RMS X', 'timeFrame': 'At the beginning and at three months', 'description': 'Mean position of the center of pressure in the mediolateral plane'}, {'measure': 'Length', 'timeFrame': 'At the beginning and at three months', 'description': 'Length of the path described by the center of pressure'}, {'measure': 'Area', 'timeFrame': 'At the beginning and at three months', 'description': 'Area of the path described by the center of pressure'}, {'measure': 'Velocity', 'timeFrame': 'At the beginning and at three months', 'description': 'Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test'}, {'measure': 'Chair Sit and Reach Test', 'timeFrame': 'At the beginning and at three months', 'description': 'To test low back and hamstring flexibility'}, {'measure': 'Back Scratch Test', 'timeFrame': 'At the beginning and at three months', 'description': 'To measure general shoulder range of motion'}, {'measure': '30-Second Chair Stand Test', 'timeFrame': 'At the beginning and at three months', 'description': 'To test leg strength and endurance'}, {'measure': 'Height', 'timeFrame': 'At the beginning and at three months', 'description': 'The distance between the lowest and highest points of a person standing upright'}, {'measure': 'Wais Circumference', 'timeFrame': 'At the beginning and at three months', 'description': 'Is used to assess central fat distribution and degree of abdominal obesity'}, {'measure': 'Hip Circumference', 'timeFrame': 'At the beginning and at three months', 'description': 'It is the greatest circumference of hip'}, {'measure': 'Waist-To-Hip Ratio', 'timeFrame': 'At the beginning and at three months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fall Due to Loss of Equilibrium']}, 'descriptionModule': {'briefSummary': 'To analyze the effects of a Pilates exercise program in Spanish postmenopausal women with Fibromyalgia', 'detailedDescription': '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.\n\nThe study will define two groups:\n\n* 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.\n* An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.\n\nOnce 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No menstrual activity for at least 12 months.\n* Present Fibromyalgia.\n* Do not participate in a weight loss program.\n* Be able to understand the instructions, programs and protocols of this project.\n\nExclusion Criteria:\n\n* Contraindications for conducting physical tests.\n* Diseases that limit the static and dynamic balance and physical activity. -\n* Central or peripheral vestibular or nerve alterations.'}, 'identificationModule': {'nctId': 'NCT03318458', 'briefTitle': 'Pilates Exercises in Spanish Women With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University of Jaén'}, 'officialTitle': 'Effects of a Program of Pilates Exercises in Spanish Women With Fibromyalgia', 'orgStudyIdInfo': {'id': 'Jaen University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates group', 'interventionNames': ['Other: Pilates']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention group'}], 'interventions': [{'name': 'Pilates', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Pilates group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23009', 'city': 'Jaén', 'country': 'Spain', 'facility': 'AFIXA', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jaén', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapy', 'investigatorFullName': 'Agustín Aibar Almazán', 'investigatorAffiliation': 'University of Jaén'}}}}