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

Primary Purpose

Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
interval training in addition to diet recommendations
diet recommendations
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Resistance

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

study group will receive interval training and diet advices

diet recommendations

Arm Description

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)17.

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

Outcomes

Primary Outcome Measures

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
sex hormones
change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'
blood lipids
blood lipids will be measured by blood analysis,
tumor markers
tumor markers will be measured by blood analysis,

Secondary Outcome Measures

Full Information

First Posted
July 8, 2020
Last Updated
May 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04471506
Brief Title
Effect of Interval Aerobic Training on Hormonal, Metabolic, and Tumor Markers in Postmenopausal
Official Title
High-intensity Interval Training Induces Hormonal and Metabolic Effects and Alters Tumor Markers Level in Obese Postmenopausal Women: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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?
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group will receive interval training and diet advices
Arm Type
Other
Arm Description
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)17.
Arm Title
diet recommendations
Arm Type
Other
Arm Description
The control group will receive diet recommendations. The volunteers will follow diet recommendations for 12 weeks
Intervention Type
Other
Intervention Name(s)
interval training in addition to diet recommendations
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
diet recommendations
Intervention Description
the control group will follow diet recommendations for 12 weeks
Primary Outcome Measure Information:
Title
insulin resistance
Description
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
Time Frame
12 weeks
Title
sex hormones
Description
change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'
Time Frame
12 weeks
Title
blood lipids
Description
blood lipids will be measured by blood analysis,
Time Frame
12 weeks
Title
tumor markers
Description
tumor markers will be measured by blood analysis,
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marwa m elsayed, phd
Phone
01156033818
Ext
02
Email
marwadd999@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marwa m elsayed, phd
Organizational Affiliation
lecturer at physical therapy faculty cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marwa m elsayed, Phd
Phone
01156033818
Ext
02
Email
marwadd999@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
one year after completion the study
IPD Sharing Access Criteria
students and scientific researchers will be allowed to access
IPD Sharing URL
http://Scholar.cu.edu.eg/p_t

Learn more about this trial

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

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