Fall Due to Loss of EquilibriumNCT03318458
Pilates Exercises in Spanish Women With Fibromyalgia
A study testing Pilates in people with Fall Due to Loss of Equilibrium, run by University of Jaén at 1 site in Spain.
Trial summary
To analyze the effects of a Pilates exercise program in Spanish postmenopausal women with Fibromyalgia Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fall Due to Loss of Equilibrium
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Program of Pilates Exercises in Spanish Women With Fibromyalgia
To analyze the effects of a Pilates exercise program in Spanish postmenopausal women with Fibromyalgia
Read the 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.
- Conditions
- Fall Due to Loss of Equilibrium
- Being tested
- Pilates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pilates group | Experimental | Not described Receives: Other: Pilates |
| No intervention group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamometer
Dynamometer will be employed to assess hand grip stregth
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the beginning and at three months
Bone Mineral Content (BMC)
Is mineral mass in bone
Measured: 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
Measured: 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
Measured: At the beginning and at three months
Lean Body Mass
The amount of lean body mass
Measured: 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
Measured: At the beginning and at three months
Percent of Body Fat (%)
Indicates the percentage of body fat to body weight
Measured: 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
Measured: 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
Measured: 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
Measured: At the beginning and at three months
CT10P
Test that evaluates the balance by walking along a straight line
Measured: 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.
Measured: 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
Measured: At the beginning and at three months
X mean
Mean value of the lateral oscillations of the Pressure Center
Measured: At the beginning and at three months
Y mean
Mean value of the anteroposterior oscillations of the Pressure Center
Measured: At the beginning and at three months
RMS X
Mean position of the center of pressure in the mediolateral plane
Measured: At the beginning and at three months
Length
Length of the path described by the center of pressure
Measured: At the beginning and at three months
Area
Area of the path described by the center of pressure
Measured: 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
Measured: At the beginning and at three months
Chair Sit and Reach Test
To test low back and hamstring flexibility
Measured: At the beginning and at three months
Back Scratch Test
To measure general shoulder range of motion
Measured: At the beginning and at three months
30-Second Chair Stand Test
To test leg strength and endurance
Measured: At the beginning and at three months
Height
The distance between the lowest and highest points of a person standing upright
Measured: At the beginning and at three months
Wais Circumference
Is used to assess central fat distribution and degree of abdominal obesity
Measured: At the beginning and at three months
Hip Circumference
It is the greatest circumference of hip
Measured: 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
Measured: At the beginning and at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Due to Loss of EquilibriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318458
- Sponsor's protocol ID
- Jaen University
- Status last verified
- Dec 2017
- First submitted
- 3 Oct 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Program of Pilates Exercises in Spanish Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03318458
- Acronym / sponsor ID
- Jaen University
- Conditions
- Fall Due to Loss of Equilibrium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pilates group | Experimental | Other: Pilates |
| No intervention group | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PilatesThe 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 | Other | Pilates group |
Primary outcome
Dynamometer
Time frame: At the beginning and at three months
Dynamometer will be employed to assess hand grip stregth
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Bone Mineral Content (BMC)
Time frame: At the beginning and at three months
Is mineral mass in bone
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
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
Lean Body Mass
Time frame: At the beginning and at three months
The amount of lean body mass
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
Percent of Body Fat (%)
Time frame: At the beginning and at three months
Indicates the percentage of body fat to body weight
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
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
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
CT10P
Time frame: At the beginning and at three months
Test that evaluates the balance by walking along a straight line
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.
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
X mean
Time frame: At the beginning and at three months
Mean value of the lateral oscillations of the Pressure Center
Y mean
Time frame: At the beginning and at three months
Mean value of the anteroposterior oscillations of the Pressure Center
RMS X
Time frame: At the beginning and at three months
Mean position of the center of pressure in the mediolateral plane
Length
Time frame: At the beginning and at three months
Length of the path described by the center of pressure
Area
Time frame: At the beginning and at three months
Area of the path described by the center of pressure
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
Chair Sit and Reach Test
Time frame: At the beginning and at three months
To test low back and hamstring flexibility
Back Scratch Test
Time frame: At the beginning and at three months
To measure general shoulder range of motion
30-Second Chair Stand Test
Time frame: At the beginning and at three months
To test leg strength and endurance
Height
Time frame: At the beginning and at three months
The distance between the lowest and highest points of a person standing upright
Wais Circumference
Time frame: At the beginning and at three months
Is used to assess central fat distribution and degree of abdominal obesity
Hip Circumference
Time frame: At the beginning and at three months
It is the greatest circumference of hip
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates in people with Fall Due to Loss of Equilibrium, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamometer (time frame: At the beginning and at three months). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.