- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07683286
Pilates Exercises Versus Intermittent Fasting Diet on Physical and Metabolic Aging Process in Obese Perimenopausal Women
Effect of Pilates Exercises Versus Intermittent Fasting Diet on Physical and Metabolic Aging Process in Obese Perimenopausal Women
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Obesity is associated with a shorter life expectancy, partly due to its role in accelerating the aging process. The conditions and comorbidities linked to obesity mirror those of age-related diseases. Individuals with obesity are at a higher risk for various age-related conditions, including cardiovascular disease (CVD), hypertension, type 2 diabetes mellitus (T2DM), and cance.
Aging is a natural part of the human life cycle, characterized by a gradual loss of physiological integrity, leading to functional decline and increased vulnerability to mortality. Alongside the onset of age-related diseases in older adults, common aging phenotypes, such as redox imbalance, mitochondrial dysfunction, increased apoptosis, cellular senescence, insufficient autophagy, and chronic inflammation, are observed in both humans and animals. Similar mechanisms underpin the onset of age-related diseases in obesity and excessive calorie intake, suggesting that obesity accelerates aging through these interconnected pathways.
Pilates has gained popularity as a holistic exercise approach that emphasizes respiration, body control, and movement precision. Current research supports the positive effects of Pilates on respiratory muscle strength, balance, overall physical performance, and quality of life. Additionally, a recent systematic review and meta-analysis concluded that Pilates is an effective alternative for improving maximal oxygen uptake (VO2max) values.
Fasting, which involves abstaining from food for extended periods ranging from hours to days, triggers significant metabolic changes referred to as the 'metabolic switch'. One of the most important metabolic shifts during fasting is the increased production of ketone bodies, such as acetoacetic acid, β-hydroxybutyric acid (β-HB), and acetone, in the liver.
Given the heightened vulnerability of obese perimenopausal women to accelerated aging processes and metabolic dysfunction, there is a critical need to identify the most effective lifestyle interventions for this high-risk population. While both Pilates exercise and intermittent fasting show promise in addressing aging-related parameters through different mechanisms, no direct comparative studies have evaluated their relative efficacy on comprehensive physical and metabolic aging markers in obese perimenopausal women.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hadeel Mohammed, Master
- Telefonní číslo: 01065489193
- E-mail: hadeltv@yahoo.com
Studijní záloha kontaktů
- Jméno: Mohamed Abo Eleinien, PHD
- Telefonní číslo: 01001414404
- E-mail: Drfawzygyna61@gmail.com
Studijní místa
-
-
-
Al Fayyum, Egypt
- Hadeel Adil Mohamed
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Their body mass index will be ranged from 30 to 35 kg/m2.
- Waist hip ratio will be > 1.
- Total cholesterol (TC) will be > 200 mg/dl.
- Triglycerides (TG) will be > 150 mg/dl.
- Low-density lipoprotein (LDL) will be > 100 mg/dl.
- High-density lipoprotein (HDL) will be < 40 mg/dl.
Exclusion Criteria:
- Diabetes type I.
- Concomitant cardiac disorders.
- Pregnant or breastfeeding.
- Eating disorders as Anorexia.
- Thyroid disorders.
- Kidney disorders.
- Severe joint issues as arthritis and post-joint replacement.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Pilates exercise group
The participants will be treated with Pilates exercises, 4 times per week, 60 minutes per session, for 12 weeks.
|
Each exercise will be ranged from 1 to 3 minutes, with a break of 10 seconds.
The exercises include: Flat Abs: Pilates Hundred; Flat Abs: Roll-Up; Obliques: Twist and Reach; Lower Back: Shoulder Bridge; Lower Body: Kneeling Side Kicks; Lower Body: Leg Swings; Stamina: Wall Chair.
|
|
Experimentální: Intermittent Fasting Diet
The participants will follow intermittent fasting diet for 12 weeks.
|
This fasting regimen involves fasting for 16 hours each day and limiting eating to an 8-hour window.
The 16:8 intermittent fasting protocol is relatively straightforward.
It divides the day into two main periods: the fasting period which is 16 hours and the 8 hours eating window .
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body weight
Časové okno: 12 weeks
|
Weight will be measured in kilograms by weight-height scale for all participants before and after treatment program.
|
12 weeks
|
|
Body mass index
Časové okno: 12 weeks
|
It will be measured by weight-height scale by dividing body weight in kilograms by height meter square.
|
12 weeks
|
|
Waist circumference
Časové okno: 12 weeks
|
The waist circumference will be measured in centimeters at the narrowest point between xipho-sternum and the iliac crest at the end of a gentle expiration.
|
12 weeks
|
|
Hip circumference
Časové okno: 12 weeks
|
Hip circumference will be measured in centimeters at the maximum circumference at the level of the femoral trochanter.
|
12 weeks
|
|
Waist-hip ratio
Časové okno: 12 weeks
|
It will be calculated by dividing waist circumference by hip circumference for all participants before and after treatment.
|
12 weeks
|
|
Resting Heart Rate Measurement
Časové okno: 12 weeks
|
Resting heart rate (RHR) is the number of heartbeats per minute (bpm) when a person is at complete rest. It is a simple indicator of cardiovascular health. it will be measured by pulse oximeter. Normal Range: Adults: 60-100 bpm |
12 weeks
|
|
Maximum Heart Rate
Časové okno: 12 weeks
|
It will be calculated through equation: 220- age
|
12 weeks
|
|
Maximum oxygen consumption (VO2 max)
Časové okno: 12 weeks
|
It will be calculated through the equation:VO2 max = 15.3 x (maximum heart rate / resting heart rate).
|
12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Assessment of the health-related quality of life
Časové okno: 12 weeks
|
It will be assessed using the short form (SF-36) questionnaire, which consists of 36 questions.
Answers will be awarded a score on a five-point scale (0-4).
The 36-question SF-36 evaluates eight health domains: physical functioning (10 questions), physical role limits (4 questions), bodily pain (2 questions), general health perceptions (5 questions), energy/vitality (4 questions), social function (2 questions), emotional role limits (3 questions), and mental health (5 questions).
The scores will be transformed to range from 0 for the worst health to 100 for the ideal health.
|
12 weeks
|
|
Total cholesterol (TC)
Časové okno: 12 weeks
|
Total cholesterol (TC) is the total concentration of cholesterol in the blood.
Normal range: <200 mg/dL (<5.2 mmol/L)
|
12 weeks
|
|
Triglycerides
Časové okno: Normal: <150 mg/dL (<1.7 mmol/L)
|
Triglycerides (TG) are the primary form of fat stored in the body and circulate in the blood as an important source of energy.
Elevated triglyceride levels are associated with an increased risk of cardiovascular disease.
Normal: <150 mg/dL (<1.7 mmol/L)
|
Normal: <150 mg/dL (<1.7 mmol/L)
|
|
High-density lipoprotein
Časové okno: 12 weeks
|
High-density lipoprotein is commonly referred to as "good cholesterol" because it transports excess cholesterol from peripheral tissues to the liver for excretion, thereby reducing cardiovascular risk.
Normal range for women: <50 mg/dL (<1.3 mmol/L)
|
12 weeks
|
|
Low-density lipoprotein
Časové okno: 12 weeks
|
Low-density lipoprotein is often called "bad cholesterol," transports cholesterol from the liver to peripheral tissues.
Elevated LDL-C is a major risk factor for atherosclerosis and cardiovascular disease.
Normal: <100 mg/dL (<2.6 mmol/L)
|
12 weeks
|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Časové okno: 12 weeks
|
It is a widely used index for estimating insulin resistance based on fasting plasma glucose and fasting serum insulin concentrations.
It is commonly used in clinical research to assess insulin sensitivity.
Normal insulin sensitivity: <2.0
|
12 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Mohamed Awad, Professor, Cairo University
- Ředitel studie: Doaa Osman, As Professor, Cairo University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P.T.REC/012/006542
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .