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NCT Number: NCT04471506

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

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?

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

55 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy

Cairo, 11432, Egypt

Location status: Recruiting

Location contact

marwa m elsayed, Phd

CONTACT

[email protected]

01156033818 ext. 02

About this study

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 .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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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., β-blockers, α-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

Treatment and study plan

Interval training

Other

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

Other

the control group will follow diet recommendations for 12 weeks

Mindfulness breathing

Other

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

Primary outcomes

  1. insulin resistance

    Time frame: 12 weeks

    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

  2. sex hormones

    Time frame: 12 weeks

    change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'

  3. blood lipids

    Time frame: 12 weeks

    blood lipids will be measured by blood analysis,

  4. tumor markers

    Time frame: 12 weeks

    tumor markers will be measured by blood analysis,

Study contacts

Contact information is provided by the study sponsor or research team.

marwa m elsayed, phd

CONTACT

[email protected]

01156033818 ext. 02

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 15, 2020
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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