Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04471506
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-07-08
Brief Title:
Effect of Interval Aerobic Training and Mindfulness Breathing on Hormonal Metabolic and Tumor Markers in Postmenopausal
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
High-intensity Interval Training and Mindfulness Breathing Induce Hormonal and Metabolic Effects and Alter Tumor Marker Levels in Obese Postmenopausal Women A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PURPOSE
to determine the effect of interval training and mindfulness breathing on sex hormones metabolic and tumor markers
BACKGROUND
Cancer is one of death top causes in many countries1 In Egypt for example cancer incidence is 1570 per 100 000 women with probability increasing up to three-fold by 2050 especially in older adult women2 Who exhibit multiple factors leading to cancer including but not limited to physical inactivity and postmenopausal obesity which considered the starting point of developing insulin resistance3
High blood insulin level stimulates cancer progression by enhancing cell proliferation decreasing cells apoptosis increased level of fatty acids in conjunction with higher tumor cell formation capacity invasion and survival4 Moreover high level of insulin resistance and adipose tissue increase the hormonal level of estradiol and testosterone coupled with lower SHBG level
It was noticed that being postmenopausal women with high adipose tissue content will increase the risk of having cancer in which adipose tissue is considered as the main source of steroids hormones that functioning in a different way rather than in premenopausal age Based on the mentioned underlying conditions postmenopausal women subjected to have variable types of cancer such as breast endometrial stomach etc6
So regular screening of cancer incidence especially in high-risk women through tumor indicators is necessitated to work against further cancer progression CEA and CA125 are low-cost tumor blood biomarkers used widely for early cancer identification recurrence monitoring and follow up which linked to proinflammatory cytokines production
HYPOTHESES
may have no effect to interval training and mindfulness breathing on sex hormones metabolic and tumor markers in postmenopausal women
RESEARCH QUESTION
Is there effect to interval training and mindfulness on sex hormones metabolic and tumor markers in postmenopausal women
to determine the effect of interval training and mindfulness breathing on sex hormones metabolic and tumor markers
BACKGROUND
Cancer is one of death top causes in many countries1 In Egypt for example cancer incidence is 1570 per 100 000 women with probability increasing up to three-fold by 2050 especially in older adult women2 Who exhibit multiple factors leading to cancer including but not limited to physical inactivity and postmenopausal obesity which considered the starting point of developing insulin resistance3
High blood insulin level stimulates cancer progression by enhancing cell proliferation decreasing cells apoptosis increased level of fatty acids in conjunction with higher tumor cell formation capacity invasion and survival4 Moreover high level of insulin resistance and adipose tissue increase the hormonal level of estradiol and testosterone coupled with lower SHBG level
It was noticed that being postmenopausal women with high adipose tissue content will increase the risk of having cancer in which adipose tissue is considered as the main source of steroids hormones that functioning in a different way rather than in premenopausal age Based on the mentioned underlying conditions postmenopausal women subjected to have variable types of cancer such as breast endometrial stomach etc6
So regular screening of cancer incidence especially in high-risk women through tumor indicators is necessitated to work against further cancer progression CEA and CA125 are low-cost tumor blood biomarkers used widely for early cancer identification recurrence monitoring and follow up which linked to proinflammatory cytokines production
HYPOTHESES
may have no effect to interval training and mindfulness breathing on sex hormones metabolic and tumor markers in postmenopausal women
RESEARCH QUESTION
Is there effect to interval training and mindfulness on sex hormones metabolic and tumor markers in postmenopausal women
Detailed Description:
HIIT group involved in an exercise program three times per week for three months in form of cycling protocol which will comprise 5 minutes warming up before exercise initiation and another 5 minutes for cooling down by the end of exercise session in form slow pedaling 50 of PHR The work interval also will comprise 8-12 cycling intervals 60s cycling work interval with 120s of passive rest or low-intensity cycling 70 of PHR between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program17 Each work interval will be maintained at a range of 50-70 rpm cycle revolutions with a speed between 20 and 40 kmh Exercise intensity will be 85 of peak heart rate PHR according to the Karvonen formula18
which corresponds to 8-10 points on the modified Borg scale19 The exercise will be supervised along the first week only with guidance to ensure that each participant masters the optimal exercise procedure
The participants will be equipped with a pulse oximeter for continuous monitoring of the heart rate prior to the start during or just after the completion of the exercise session Also Mindful breathing is a exercise that involves using breathing as an object of attention 15-minute mindful breathing intervention will be adapted It consists of the following three steps a adopt a physical posture b establish a mindfulness anchor and c maintain mindfulness Healthy diet instructions will be recommended for those non-dietitian obese women without following specific diet programs that could influence our results
which corresponds to 8-10 points on the modified Borg scale19 The exercise will be supervised along the first week only with guidance to ensure that each participant masters the optimal exercise procedure
The participants will be equipped with a pulse oximeter for continuous monitoring of the heart rate prior to the start during or just after the completion of the exercise session Also Mindful breathing is a exercise that involves using breathing as an object of attention 15-minute mindful breathing intervention will be adapted It consists of the following three steps a adopt a physical posture b establish a mindfulness anchor and c maintain mindfulness Healthy diet instructions will be recommended for those non-dietitian obese women without following specific diet programs that could influence our results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None