跳至主要内容
临床试验/NCT03318458
NCT03318458已完成不适用

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

University of Jaén2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
ABC-16 (Activities Specific Balance Confidence Scale)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

ABC-16 (Activities Specific Balance Confidence Scale)

时间窗: 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)

时间窗: 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)

时间窗: At the beginning and at three months

Is mineral mass in bone

Y mean

时间窗: At the beginning and at three months

Mean value of the anteroposterior oscillations of the Pressure Center

VAS-Fatigue

时间窗: 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)

时间窗: 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.

时间窗: At the beginning and at three months

Is the sum of Body Fat and Fat Free Mass

Body Fat Mass

时间窗: 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

Percent of Body Fat (%)

时间窗: At the beginning and at three months

Indicates the percentage of body fat to body weight

FSS (Fatigue Severity Scale)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: At the beginning and at three months

Dynamometer will be employed to assess hand grip stregth

VAS-pain

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: At the beginning and at three months

Test that evaluates the balance by walking along a straight line

MRS (Menopause Rating Scale)

时间窗: 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

时间窗: At the beginning and at three months

The amount of lean body mass

Velocity

时间窗: 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

时间窗: At the beginning and at three months

To test low back and hamstring flexibility

BMI (Body Mass Index)

时间窗: 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)

时间窗: At the beginning and at three months

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

X mean

时间窗: At the beginning and at three months

Mean value of the lateral oscillations of the Pressure Center

Segmental Analysis

时间窗: 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

时间窗: At the beginning and at three months

Mean position of the center of pressure in the mediolateral plane

STABILOMETRIC PLATFORM

时间窗: 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

时间窗: At the beginning and at three months

Length of the path described by the center of pressure

Wais Circumference

时间窗: At the beginning and at three months

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

Area

时间窗: At the beginning and at three months

Area of the path described by the center of pressure

Height

时间窗: 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

时间窗: At the beginning and at three months

To test leg strength and endurance

Back Scratch Test

时间窗: At the beginning and at three months

To measure general shoulder range of motion

Hip Circumference

时间窗: At the beginning and at three months

It is the greatest circumference of hip

Waist-To-Hip Ratio

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University of Jaén
申办方类型
Other
责任方
Principal Investigator
主要研究者

Agustín Aibar Almazán

Physiotherapy

University of Jaén

研究点 (2)

Loading locations...

相似试验