Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
9. september 2021 oppdatert av: Agustín Aibar Almazán, University of Jaén
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
107
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Jaén, Spania, 23002
- Center of active participation of seniors of Jaén "Catedral"
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- 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.
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Pilates gruppe
Denne gruppen får fysisk trening basert på pilatesøvelser
|
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. |
|
Ingen inngripen: Ingen intervensjonsgruppe
Denne gruppen får ingen behandling
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skjelettmuskelmasse (kg)
Tidsramme: I begynnelsen og ved tre måneder
|
Beregnes basert på muskelmassen til lemmene, som nesten består av skjelettmuskulatur og tar opp omtrent 70 % av den totale skjelettmuskulaturen i kroppen
|
I begynnelsen og ved tre måneder
|
|
TUG (Timed Up and Go-test)
Tidsramme: I begynnelsen og ved tre måneder
|
Er en enkel test som brukes til å vurdere en persons mobilitet og fysiske funksjon
|
I begynnelsen og ved tre måneder
|
|
X betyr
Tidsramme: I begynnelsen og ved tre måneder
|
Gjennomsnittlig verdi av sidesvingningene til trykksenteret
|
I begynnelsen og ved tre måneder
|
|
Y mener
Tidsramme: I begynnelsen og ved tre måneder
|
Gjennomsnittlig verdi av de anteroposteriore oscillasjonene til trykksenteret
|
I begynnelsen og ved tre måneder
|
|
Dynamometer
Tidsramme: At the beginning and at three months
|
Dynamometer will be employed to assess hand grip stregth.
|
At the beginning and at three months
|
|
ABC-16 (Activities Specific Balance Confidence Scale)
Tidsramme: At the beginning and at three months
|
Questionnaire that assesses balance confidence in performing activities of daily living.
|
At the beginning and at three months
|
|
FES-I (Falls Efficacy Scale-International)
Tidsramme: At the beginning and at three months
|
Questionnaire that evaluates the fear of falling.
|
At the beginning and at three months
|
|
Barthel index
Tidsramme: At the beginning and at three months
|
Measures disability or dependence in activities of daily living
|
At the beginning and at three months
|
|
KATZ INDEX
Tidsramme: At the beginning and at three months
|
Is a widely used tool to assess the level of independency in older adults.
|
At the beginning and at three months
|
|
FSS (Fatigue Severity Scale)
Tidsramme: 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.
|
At the beginning and at three months
|
|
PSQI (Pittsburgh Sleep Quality Index)
Tidsramme: At the beginning and at three months
|
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
|
At the beginning and at three months
|
|
HADS (The Hospital Anxiety And Depression)
Tidsramme: 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.
|
At the beginning and at three months
|
|
SF-36 (The Short Form-36 Health Survey)
Tidsramme: At the beginning and at three months
|
Used extensively for assessing health-related quality of life.
|
At the beginning and at three months
|
|
MRS (Menopause Rating Scale):
Tidsramme: At the beginning and at three months
|
Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
|
At the beginning and at three months
|
|
FSFI (Female Sexual Function Index)
Tidsramme: At the beginning and at three months
|
Is a brief questionnaire that evaluates sexual functioning in women.
|
At the beginning and at three months
|
|
INBODY
Tidsramme: 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.
|
At the beginning and at three months
|
|
Bone Mineral Content (BMC)
Tidsramme: At the beginning and at three months
|
Is mineral mass in bone.
|
At the beginning and at three months
|
|
Body Weight
Tidsramme: At the beginning and at three months
|
Is the sum of Body Fat and Fat Free Mass.
|
At the beginning and at three months
|
|
Lean Body Mass
Tidsramme: At the beginning and at three months
|
The amount of lean body mass.
|
At the beginning and at three months
|
|
Body Fat Mass
Tidsramme: 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.
|
At the beginning and at three months
|
|
Percent of Body Fat (%)
Tidsramme: At the beginning and at three months
|
Indicates the percentage of body fat to body weight.
|
At the beginning and at three months
|
|
BMI (Body Mass Index)
Tidsramme: 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.
|
At the beginning and at three months
|
|
Segmental Analysis
Tidsramme: 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.
|
At the beginning and at three months
|
|
OPTOGAIT
Tidsramme: 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
|
At the beginning and at three months
|
|
CT10P
Tidsramme: At the beginning and at three months
|
Test that evaluates the balance by walking along a straight line.
|
At the beginning and at three months
|
|
STABILOMETRIC PLATFORM
Tidsramme: 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.
|
At the beginning and at three months
|
|
RMS X
Tidsramme: At the beginning and at three months
|
Mean position of the center of pressure in the mediolateral plane.
|
At the beginning and at three months
|
|
RMS Y
Tidsramme: At the beginning and at three months
|
Mean position of the center of pressure in the anteroposterior plane
|
At the beginning and at three months
|
|
Length
Tidsramme: At the beginning and at three months
|
Length of the path described by the center of pressure.
|
At the beginning and at three months
|
|
Area
Tidsramme: At the beginning and at three months
|
Area of the path described by the center of pressure.
|
At the beginning and at three months
|
|
Velocity
Tidsramme: 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.
|
At the beginning and at three months
|
|
Isaac test
Tidsramme: At the beginning and at three months
|
Questionnaire that measures verbal fluency.
|
At the beginning and at three months
|
|
trail making test part a y b
Tidsramme: At the beginning and at three months
|
Neuropsychological test of visual attention and task switching.
|
At the beginning and at three months
|
|
mmse (mini-mental state examination)
Tidsramme: At the beginning and at three months
|
A tool that can be used to systematically and thoroughly assess mental status.
|
At the beginning and at three months
|
|
chair sit and reach test
Tidsramme: At the beginning and at three months
|
To test low back and hamstring flexibility.
|
At the beginning and at three months
|
|
back scratch test
Tidsramme: At the beginning and at three months
|
To measure general shoulder range of motion.
|
At the beginning and at three months
|
|
30-second chair stand test
Tidsramme: At the beginning and at three months
|
To test leg strength and endurance.
|
At the beginning and at three months
|
|
height
Tidsramme: At the beginning and at three months
|
The distance between the lowest and highest points of a person standing upright.
|
At the beginning and at three months
|
|
waist circumference
Tidsramme: At the beginning and at three months
|
Is used to assess central fat distribution and degree of abdominal obesity.
|
At the beginning and at three months
|
|
hip circumference
Tidsramme: At the beginning and at three months
|
It is the greatest circumference of hip
|
At the beginning and at three months
|
|
waist-to-hip ratio
Tidsramme: 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.
|
At the beginning and at three months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2017
Primær fullføring (Faktiske)
1. november 2017
Studiet fullført (Faktiske)
27. februar 2018
Datoer for studieregistrering
Først innsendt
22. juni 2017
Først innsendt som oppfylte QC-kriteriene
23. juni 2017
Først lagt ut (Faktiske)
28. juni 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UJaen
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .