NCT04471506

Effect of Interval Aerobic Training and Mindfulness Breathing on Hormonal, Metabolic, and Tumor Markers in Postmenopausal

Recruiting now NA Last updated 4 September 2024

What this trial tests

NA trial testing interval training in Insulin Resistance in 60 participants. Currently enrolling.

Timeline

1 August 2020

Primary endpoint
1 December 2024

12 December 2025

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	60
Start date	1 August 2020
Primary completion	1 December 2024
Estimated completion	12 December 2025
Sites	1 location across Egypt

Drugs / interventions tested

• interval training
• diet recommendations
• mindfulness breathing

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

Cairo University

Who can join

Adults 55 to 65, female only, with Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 157.0 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?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. High-intensity Interval Training and Mindfulness Breathing Induce Hormonal, Metabolic, and Anticarcinogenic Effects in Obese Postmenopausal Women: A Randomized Controlled Trial.
   Nagy EN, Shafiek M, Elsheimy H, Mogahed HG, et al · · 2025 · PMID 40891691 · DOI 10.1177/2515690x251372718