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El ensayo clínico NCT06445842 para Postmenopáusica está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Short-term Circuit Training on Muscle Mass and Quality of Life in Sedentary Postmenopausal Women

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Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06445842 es un ensayo intervencionista para Postmenopáusica. Su estado actual es: reclutando. El ensayo se inició el 29 de mayo de 2024, con el objetivo de reclutar a 46 participantes. Dirigido por la Universidad de Loma Linda, se espera que finalice el 31 de enero de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 4 de julio de 2025.
Resumen
The purpose of this graduate student research study is to provide healthcare professionals with evidence of the potential of circuit strength training in improving the physical and psychosocial well-being of postmenopausal women.
Descripción detallada
A randomized controlled trial design will investigate the effects of circuit training on the following dependent variables: muscle mass, strength, inflammatory markers, balance, functional capacity, and quality of life.

Body composition measurements will utilize IN-BODY technology. The Motor Control Screen Lower Body (MCS) will determine balance. For assessing strength, we will use the Dynamometer, specifically for grip strength. Ultrasound will gauge muscle mass, while the BTE (Baltimore Therapeutic Equipment) will handle quadriceps isometric muscle tests. The Peak Expiratory Flow (PEF) will evaluate respiratory strength. Participants' aerobic capacity will be gauged via the 6-minute Walk Test. Heart Rate Variability (HRV) evaluations will rely on Polar devices, and the Fitbit Inspire3. We will also employ the Fitbit Inspire3for tracking sleep quality. Psychosocial factors will be examined through: Falls Efficacy Scale-International (FES-I), SF-36 QOL Questionnaire, PHQ-ADS, and the Pittsburgh Sleep Quality Index (PSQI). Activity levels will be determined through the IPAQ-SF questionnaire. The questionnaires will be completed on Qualtrics or in hardcopy format. Blood tests will monitor inflammatory markers such as IL-6, TNF-α, and hs-CRP. The study will be conducted over 10 weeks, starting from the initial and final data collection. During the first week, participants will need to visit the research laboratory to undergo basic tests. After completing all procedures, including informed consent and blood collection, participants will be randomly assigned (computerized generated) to the experimental (exercise) group (N=18) or control (non-exercise) group (N=18).

In the first week, the exercise group will participate for two additional days to introduce the exercise, evaluate their movements, and determine their maximum exercise capacity. The experimental group will participate in circuit strength training sessions lasting approximately 45 minutes three times a week for 8 weeks. The exercise protocol will consist of a 10-minute warm-up and cool-down, two sets of 12-minute high-intensity circuit training exercises, and a 3-minute break between sets. The intensity of the exercises will be gradually increased every two weeks for 8 weeks.

Meanwhile, the control group will need to maintain their sedentary lifestyle without changing their activity levels or diet.

After completing the 8-week exercise protocol, all participants will visit the lab for a second round of data collection. Additionally, the exercise protocol will be shown to the control group during the retest day of the study.

Título oficial

The Effects of Short-Term Circuit Strength Training Intervention on Muscle Mass, Metabolic Health, Balance, Quality of Life, and Inflammaging in Sedentary Postmenopausal Women

Condiciones médicas
Postmenopáusica
Otros ID del ensayo
  • 5230490
Número del NCT
Inicio del ensayo (real)
2024-05-29
Última actualización
2025-07-04
Fecha de finalización (estimada)
2026-01-31
Inscripción (prevista)
46
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
postmenopausal
balance
Objetivo principal
Otros
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalExercise Group
This group will perform exercises three times a week for eight weeks, with each session lasting approximately 45 minutes.
Ejercicio
The protocol involves a 10-minute warm-up and cool-down session, followed by two sets of high-intensity circuit training exercises (bench press, squats, overhead press, calf raising, barbell row, deadlifts) that last 12 minutes each (6 stations×2sets). There will be a 3-minute break between the exercise sets. The heart rate required during the exercise will be between 70-90% of their maximum capacity and a pre-scale rate of 7.5. The intensity of the exercise will be progressive each two weeks, commencing at 50% of their one rep max and increasing to 80% in their last week. During the initial phase, participants will be required to complete eight reps for each exercise. We will encourage them to increase their intensity level every two weeks.
Comparador activoNon-Exercise Group
This group will maintain their sedentary lifestyle and will not make any changes to their diet or activity levels during this period
Sin ejercicio
This group will need to maintain their sedentary lifestyle without changing their activity levels or diet
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
sleep quality
The Pittsburgh Sleep Quality Index will be used to measure any trouble sleeping.
change between baseline and eight weeks
IL-6 Biomarker
Inflammatory biomarker IL-6 will be tested using a blood draw.
change between baseline and eight weeks
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
50 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
  • Females aged between 50 and 75 years.
  • Self-reported postmenopausal status (i.e., cessation of menstruation for a minimum of 12 months).
  • Physically capable of participating in an exercise intervention.
  • No engagement in structured resistance or aerobic training programs in the six months preceding the study.

  • Classification as moderate and highly active on the International Physical Activity Questionnaire (IPAQ) (600-3000 MET-minutes/week for "moderate" and higher than 3000 MET-minutes/week for "high" score)
  • Diagnosis of any health condition that constitutes a contraindication to physical exercise (e.g., significant cardiovascular disease, orthopedic or neuromuscular restrictions impacting exercise performance or safety).
  • Regular use of medication with the potential to affect study outcomes (e.g., corticosteroids, immunosuppressants).
Contactos centrales del ensayo
Contacto: Everett Lohman, Dsc, (909) 558-1000, [email protected]
1 Sitios del ensayo en 1 países

California

Loma Linda University, Loma Linda, California, 92354, United States
Everett Lohman, DSc, Contacto, 909-558-1000, [email protected]
Reclutando