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

Insulin Resistance Clinical Trial

Official title:

High-intensity Interval Training Induces Hormonal and Metabolic Effects and Alters Tumor Markers Level in Obese Postmenopausal Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04471506
• Other study ID #: P.T.REC/012/004118
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 12, 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: marwa m elsayed, phd
• Phone: 01156033818
• Email: marwadd999[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PURPOSE:

to determine the effect of interval training 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 on sex hormones , metabolic and tumor markers in postmenopausal women

RESEARCH QUESTION:

Is there effect to interval training on sex hormones , metabolic and tumor markers in postmenopausal women?

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 program)17. Each work interval will be maintained at a range of 50-70 rpm (cycle revolutions) with a speed between 20 and 40 km/h. 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. Healthy diet instructions will be recommended for those non-dietitian obese women without following specific diet programs that could influence our results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 12, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 65 Years

Eligibility

Inclusion Criteria:

• Sixty Postmenopausal women (55-65 y)

• Body mass index (BMI) ranged from 35 to 39.9 kg/m2

• Postmenopausal more than 2 years

Exclusion Criteria:

• • women receiving weight-reduction interventions

• taking lipid lowering drugs

• regular medications(e.g., ß-blockers, a-blockers, digoxin, diuretics, aspirin, nitrates, Presently using sex hormones)

• having active chronic illness (e.g., rheumatoid arthritis, hyperthyroidism, and inflammatory bowel disease) and diabetes mellitus or other (unstable) endocrine-related diseases

• cognitive impairment that will make it difficult to partake in the study

• presence of malignant disease

• blood donation within the last 30 days

• Participation as a subject in any type of study or research during the prior 90 days

• smoking

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• interval training in addition to diet recommendations
Ixercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 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 program).
• diet recommendations
the control group will follow diet recommendations for 12 weeks

Locations

Country	Name	City	State
Egypt	Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance	insulin resistance will be measured by homeostasis model assessment (HOMA) index of change of insulin-resistance by homeostasis model assessment insulin resistance ( HOMA -IR )index	12 weeks
Primary	sex hormones	change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'	12 weeks
Primary	blood lipids	blood lipids will be measured by blood analysis,	12 weeks
Primary	tumor markers	tumor markers will be measured by blood analysis,	12 weeks