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

NCT04471506 | Recruiting DMC

• 1 other identifier: P.T.REC/012/004118
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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?

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (4)

• 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

• sex hormones

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

  12 weeks

• blood lipids

  blood lipids will be measured by blood analysis,

  12 weeks

• tumor markers

  tumor markers will be measured by blood analysis,

  12 weeks

Study Arms (2)

study group will receive interval training and mindfulness breathing

OTHER

exercise 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). 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

Other: interval training; Other: diet recommendations; Other: mindfulness breathing

diet recommendations

OTHER

The control group will receive diet recommendations. The volunteers will follow diet recommendations for 12 weeks

Other: diet recommendations

Interventions

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).

study group will receive interval training and mindfulness breathing

diet recommendations OTHER

the control group will follow diet recommendations for 12 weeks

diet recommendations; study group will receive interval training and mindfulness breathing

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

study group will receive interval training and mindfulness breathing

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sixty Postmenopausal women (55-65 y)
• Body mass index (BMI) ranged from 35 to 39.9 kg/m2
• Postmenopausal more than 2 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy

Cairo, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• marwa m elsayed, phd

  lecturer at physical therapy faculty cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa m elsayed, phd

CONTACT

01156033818; marwadd999@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 15, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 12, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year after completion the study
• Access Criteria: students and scientific researchers will be allowed to access

Locations

EG (1)