Fall Due to Loss of EquilibriumNCT03201107
Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
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 on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 years and older, 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
- 107 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2017to 27 Feb 2018
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No menstrual activity for at least 12 months.
- Present obesity and / or sarcopenic.
- 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.
Spain1 site
Center of active participation of seniors of Jaén "Catedral"
Jaén, 23002
About this study
Official title: Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
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
Training based on a basic level Pilates exercise program will be as follows:
A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty.
| Study group | Role | What they receive |
|---|---|---|
| Pilates group | Experimental | This group receives physical training based on pilates exercises Receives: Other: Pilates |
| No intervention group | No intervention | This group does not receive any treatment |
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.
Measured: At the beginning and at three months
FES-I (Falls Efficacy Scale-International)
Questionnaire that evaluates the fear of falling.
Measured: At the beginning and at three months
Barthel index
Measures disability or dependence in activities of daily living
Measured: At the beginning and at three months
KATZ INDEX
Is a widely used tool to assess the level of independency in older adults.
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.
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 sleep quality.
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.
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.
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.
Measured: At the beginning and at three months
FSFI (Female Sexual Function Index)
Is a brief questionnaire that evaluates sexual functioning in women.
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.
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
OPTOGAIT
Is an innovative system for movement analysis and functional assessment of patients with normal or pathological conditions. REACTION TEST: This test detects the time between one optical/acoustic impulse and the patient's movement. It can be used to measure simple reactions or more complex movements
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
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
RMS Y
Mean position of the center of pressure in the anteroposterior 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
Isaac test
Questionnaire that measures verbal fluency.
Measured: At the beginning and at three months
trail making test part a y b
Neuropsychological test of visual attention and task switching.
Measured: At the beginning and at three months
mmse (mini-mental state examination)
A tool that can be used to systematically and thoroughly assess mental status.
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
waist 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 posted28 Jun 2017
- Study start1 Aug 2017
- Primary completion1 Nov 2017
- Study completion27 Feb 2018
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
- 107 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
- NCT03201107
- Sponsor's protocol ID
- UJaen
- Status last verified
- Sep 2021
- First submitted
- 22 Jun 2017
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03201107
- Acronym / sponsor ID
- UJaen
- Conditions
- Fall Due to Loss of Equilibrium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 28 Jun 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 on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
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: PilatesThis group receives physical training based on pilates exercises |
| No intervention group | No intervention | –This group does not receive any treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No menstrual activity for at least 12 months.
- Present obesity and / or sarcopenic.
- 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 |
|---|---|---|
| PilatesTraining based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty. | 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.
FES-I (Falls Efficacy Scale-International)
Time frame: At the beginning and at three months
Questionnaire that evaluates the fear of falling.
Barthel index
Time frame: At the beginning and at three months
Measures disability or dependence in activities of daily living
KATZ INDEX
Time frame: At the beginning and at three months
Is a widely used tool to assess the level of independency in older adults.
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.
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 sleep quality.
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.
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.
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.
FSFI (Female Sexual Function Index)
Time frame: At the beginning and at three months
Is a brief questionnaire that evaluates sexual functioning in women.
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
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.
OPTOGAIT
Time frame: At the beginning and at three months
Is an innovative system for movement analysis and functional assessment of patients with normal or pathological conditions. REACTION TEST: This test detects the time between one optical/acoustic impulse and the patient's movement. It can be used to measure simple reactions or more complex movements
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.
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.
RMS Y
Time frame: At the beginning and at three months
Mean position of the center of pressure in the anteroposterior 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.
Isaac test
Time frame: At the beginning and at three months
Questionnaire that measures verbal fluency.
trail making test part a y b
Time frame: At the beginning and at three months
Neuropsychological test of visual attention and task switching.
mmse (mini-mental state examination)
Time frame: At the beginning and at three months
A tool that can be used to systematically and thoroughly assess mental status.
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.
waist 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 16 Sep 2021.
- Individual participant dataSharing planned: No
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 16 Sep 2021. 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 41 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 16 Sep 2021.