Pilates Exercises in Spanish Women With Fibromyalgia
Primary Purpose
Fall Due to Loss of Equilibrium
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pilates
Sponsored by
About this trial
This is an interventional treatment trial for Fall Due to Loss of Equilibrium
Eligibility Criteria
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.
Sites / Locations
- AFIXA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pilates group
No intervention group
Arm Description
Outcomes
Primary Outcome Measures
Dynamometer
Dynamometer will be employed to assess hand grip stregth
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.
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.
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.
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.
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.
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.
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.
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.
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.
INBODY
Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat
Bone Mineral Content (BMC)
Is mineral mass in bone
Body Weight: is the sum of Body Fat and Fat Free Mass.
Is the sum of Body Fat and Fat Free Mass
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
Lean Body Mass
The amount of lean body mass
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
Percent of Body Fat (%)
Indicates the percentage of body fat to body weight
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
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
TUG (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function
CT10P
Test that evaluates the balance by walking along a straight line
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.
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
X mean
Mean value of the lateral oscillations of the Pressure Center
Y mean
Mean value of the anteroposterior oscillations of the Pressure Center
RMS X
Mean position of the center of pressure in the mediolateral plane
Length
Length of the path described by the center of pressure
Area
Area of the path described by the center of pressure
Velocity
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
To test low back and hamstring flexibility
Back Scratch Test
To measure general shoulder range of motion
30-Second Chair Stand Test
To test leg strength and endurance
Height
The distance between the lowest and highest points of a person standing upright
Wais Circumference
Is used to assess central fat distribution and degree of abdominal obesity
Hip Circumference
It is the greatest circumference of hip
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03318458
Brief Title
Pilates Exercises in Spanish Women With Fibromyalgia
Official Title
Effects of a Program of Pilates Exercises in Spanish Women With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To analyze the effects of a Pilates exercise program in Spanish postmenopausal women with Fibromyalgia
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall Due to Loss of Equilibrium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilates group
Arm Type
Experimental
Arm Title
No intervention group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention 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
Primary Outcome Measure Information:
Title
Dynamometer
Description
Dynamometer will be employed to assess hand grip stregth
Time Frame
At the beginning and at three months
Title
ABC-16 (Activities Specific Balance Confidence Scale)
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.
Time Frame
At the beginning and at three months
Title
FES-I (Falls Efficacy Scale-International)
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.
Time Frame
At the beginning and at three months
Title
FSS (Fatigue Severity Scale)
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.
Time Frame
At the beginning and at three months
Title
FIQ (Fybromialgia Impact Questionnaire)
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.
Time Frame
At the beginning and at three months
Title
VAS-Fatigue
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.
Time Frame
At the beginning and at three months
Title
VAS-pain
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.
Time Frame
At the beginning and at three months
Title
PSQI (Pittsburgh Sleep Quality Index)
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.
Time Frame
At the beginning and at three months
Title
HADS (The Hospital Anxiety And Depression)
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.
Time Frame
At the beginning and at three months
Title
SF-36 (The Short Form-36 Health Survey)
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.
Time Frame
At the beginning and at three months
Title
INBODY
Description
Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat
Time Frame
At the beginning and at three months
Title
Bone Mineral Content (BMC)
Description
Is mineral mass in bone
Time Frame
At the beginning and at three months
Title
Body Weight: is the sum of Body Fat and Fat Free Mass.
Description
Is the sum of Body Fat and Fat Free Mass
Time Frame
At the beginning and at three months
Title
Skeletal Muscle Mass (kg)
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
Time Frame
At the beginning and at three months
Title
Lean Body Mass
Description
The amount of lean body mass
Time Frame
At the beginning and at three months
Title
Body Fat Mass
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
Time Frame
At the beginning and at three months
Title
Percent of Body Fat (%)
Description
Indicates the percentage of body fat to body weight
Time Frame
At the beginning and at three months
Title
BMI (Body Mass Index)
Description
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat
Time Frame
At the beginning and at three months
Title
Segmental Analysis
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
Time Frame
At the beginning and at three months
Title
TUG (Timed Up and Go test)
Description
Is a simple test used to assess a person's mobility and physical function
Time Frame
At the beginning and at three months
Title
CT10P
Description
Test that evaluates the balance by walking along a straight line
Time Frame
At the beginning and at three months
Title
MRS (Menopause Rating Scale)
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.
Time Frame
At the beginning and at three months
Title
STABILOMETRIC PLATFORM
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
Time Frame
At the beginning and at three months
Title
X mean
Description
Mean value of the lateral oscillations of the Pressure Center
Time Frame
At the beginning and at three months
Title
Y mean
Description
Mean value of the anteroposterior oscillations of the Pressure Center
Time Frame
At the beginning and at three months
Title
RMS X
Description
Mean position of the center of pressure in the mediolateral plane
Time Frame
At the beginning and at three months
Title
Length
Description
Length of the path described by the center of pressure
Time Frame
At the beginning and at three months
Title
Area
Description
Area of the path described by the center of pressure
Time Frame
At the beginning and at three months
Title
Velocity
Description
Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test
Time Frame
At the beginning and at three months
Title
Chair Sit and Reach Test
Description
To test low back and hamstring flexibility
Time Frame
At the beginning and at three months
Title
Back Scratch Test
Description
To measure general shoulder range of motion
Time Frame
At the beginning and at three months
Title
30-Second Chair Stand Test
Description
To test leg strength and endurance
Time Frame
At the beginning and at three months
Title
Height
Description
The distance between the lowest and highest points of a person standing upright
Time Frame
At the beginning and at three months
Title
Wais Circumference
Description
Is used to assess central fat distribution and degree of abdominal obesity
Time Frame
At the beginning and at three months
Title
Hip Circumference
Description
It is the greatest circumference of hip
Time Frame
At the beginning and at three months
Title
Waist-To-Hip Ratio
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
Time Frame
At the beginning and at three months
10. Eligibility
Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
AFIXA
City
Jaén
ZIP/Postal Code
23009
Country
Spain
12. IPD Sharing Statement
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Pilates Exercises in Spanish Women With Fibromyalgia
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