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Effect of Aerobic Exercise and Diet on Anthropometric and Hematological Measurements in Obese Anemic Women

Primary Purpose

Obesity, Iron Deficiency Anemia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
combination of aerobic exercise and healthy diet
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Age will ranges from 30 to 40 years. 2. BMI will ranges from 30 to 34.9 kg/m2 3. Hemoglobin level will ranges from 8 to 11 g/dl. 4. All of participants suffer from iron deficiency anemia. 5. Same level of physical activity according to physical activity index. 6. Same level of education and income.

Exclusion Criteria:

  • 1. Cognitive impairment that prevents participants from performing the evaluations and who are unable to understand and sign the written informed consent.

    2. Hypertension. 3. diabetes mellitus 4. Disabling musculoskeletal disorder. 5. Patients with coronary artery disease or heart failure 6. Peripheral vascular disease in lower limb as deep venous thrombosis. 7. Stroke and bone disease, renal, liver, endocrinal disorders, cancer, or chemotherapy.

    8. Different types of anemia. 9. Worms' affection. 10. Pregnancy and lactation. 11. Vitamins deficiency. 12. Six months post large surgeries.

Sites / Locations

  • Faculty of Physical Therapy, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group, group A

healthy diet

Arm Description

Thirty patients in this group will perform aerobic exercise in the form of walking on electric treadmill three times/ week day after day and low caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks.

ow caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks.

Outcomes

Primary Outcome Measures

BMI in kg/m2
The anthropometric measurements will be detected via the in body scale. BMI (kg/m2) will be measured for all participants by dividing each participant's body weight (kg) by their heights (m2). Further, WC will be estimated during full expiration using an elastic tape midway between the last rib and the upper iliac crest border.

Secondary Outcome Measures

RBCs in cells/ml
Blood sample analysis to show the hematological measurements level, each participant will be asked to lie in half- lying position, with well supported back and arms. The antecubital area will be cleaned with alcohol. Blood sample will be drawn from the brachial vein from all participants by disposable sterile syringe.
HB in g/dl
blood sample analysis
MCV in fl/cell
blood sample analysis
MCH in pg/cell
blood sample analysis
MCHC in g/dl
blood sample analysis
RDW in %
blood sample analysis
WBCs /mm3
blood sample analysis
Platelets count /mm3
blood sample analysis
serum ferritin in ng/ml
blood sample analysis

Full Information

First Posted
November 7, 2021
Last Updated
December 14, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05165680
Brief Title
Effect of Aerobic Exercise and Diet on Anthropometric and Hematological Measurements in Obese Anemic Women
Official Title
Effect of Aerobic Exercise and Diet on Anthropometric and Hematological Measurements in Obese Anemic Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (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
No

5. Study Description

Brief Summary
Obesity and iron deficiency (ID) are two forms of the most usual nutritional disorders worldwide. Iron deficiency remains the most common nutritional deficiency and cause of anemia worldwide. Populations in the developing countries, premenopausal females, pregnant women, children, vegetarians and frequent blood donors are largely affected by iron deficiency due to low dietary intake, inadequate bioavailable iron, increased iron demand required for growth and development, iron losses and changes in blood volume. WHO recognized obesity as disease, which is prevalent in both developing and developed countries. Overweight and obesity are now so common and thereby replacing the more traditional public health concerns (under nutrition and infectious diseases) as some of most significant contributors to ill health. The aim of this study is to investigate effect of aerobic exercise and diet on obese anemic premenopausal women which not clarified previously. It will be hypothesized that: There will be no significant effect of aerobic exercise and diet on the anthropometric and hematological measurements in obese anemic women.
Detailed Description
Low level of serum iron was observed with weight gain and increasing BMI, both iron deficiency and obesity are worldwide epidemics affecting billions with regional variation. Iron-deficiency anemia has a substantial effect on the lives of premenopausal women in both low-income and developed countries. A low level of iron, leading to anemia, can result from various causes. The causes of iron-deficiency anemia are pregnancy or childhood growth spurts, Heavy menstrual periods. Iron-deficiency anemia is chronic and frequently asymptomatic and thus may often go undiagnosed. Symptoms include tiredness, lethargy, feeling faint and becoming breathless easily, headaches, irregular heartbeats (palpitations), altered taste, sore mouth and ringing in the ears (tinnitus). Anemia in pregnancy increases the risk of complications in both mother and baby such as low birth weight baby, preterm (premature) delivery and postnatal depression. Low iron reserves in the baby may also lead to anemia in the newborn baby. Several factors may explain why greater adiposity increases risk for anemia. However, even if diets of overweight individuals are not lower in iron, the absorption of the iron may be reduced because increased circulating hepcidin (a 25-amino-acid peptide hormone with a key role in body iron regulation, is produced mainly by the liver but also, possibly, by adipose tissue in obesity may reduce iron absorption, Iron requirements in overweight individuals may be increased due to larger blood volume and higher basal iron losses with higher body weight. women suggest greater adiposity is associated with lower fractional iron absorption in humans. Exercise training can increase total Hb and red cell mass, which enhances oxygen-carrying capacity. The possible underlying mechanisms are proposed to come mainly from bone marrow, including stimulated erythropoiesis with hyperplasia of the hematopoietic bone marrow, improvement of the hematopoietic microenvironment induced by exercise training, and hormone- and cytokine-accelerated erythropoiesis. The effects of exercise training on counteracting anemia have been explored and evaluated. The results of the research available to date are controversial, and it seems that significant methodological limitations exist. However, exercise training might be a promising, additional, safe and economical method to help improve anemia. There is a need for further investigation into the effects of and guidelines for exercise interventions in this population of patients. Largely, the prevailing evidence suggests that a healthy mode of weight loss in obese subjects is accompanied by an improvement of inflammatory markers along with re-established dietary iron absorption and serum iron concentrations as an indication for re-establishment of physiological iron homeostasis. Treating anemia is a matter of how much food we eat that aid in hemoglobin synthesis. In general, to treat anemia, focus should be placed on foods that are good sources of iron, copper, zinc, folic acid, Vitamin B-12, protein, fruits, vegetables, meat, honey, legumes and nuts. Sixty anemic obese premenopausal women participants, their ages will range from 30 to 40 years. The participants will be selected from General Zagazig Hospital. All participants will be randomly assigned into two groups equal in number; Experimental group and control group. Experimental group will receive a program of aerobic exercise, low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks , while control group will only receive low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks . Participants' demographic data will be collected as marital status, length of menstrual cycle, level of income, level of education, occupation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty anemic obese premenopausal women, their ages will range from 30 to 40 years. The participants will be selected from General Zagazig Hospital. All participants will be randomly assigned into two groups equal in number; Experimental group and control group. Experimental group will receive a program of aerobic exercise, low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks , while control group will only receive low caloric diet rich in iron, vitamin c, and folate for 3 times per week and Iron supplements for 12 weeks . Participants' demographic data will be collected as marital status, length of menstrual cycle, level of income, level of education, occupation.
Masking
ParticipantInvestigator
Masking Description
double blinded as neither the subjects nor the investigators are aware of the treatment assignment until the end of the trial
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group, group A
Arm Type
Experimental
Arm Description
Thirty patients in this group will perform aerobic exercise in the form of walking on electric treadmill three times/ week day after day and low caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks.
Arm Title
healthy diet
Arm Type
Active Comparator
Arm Description
ow caloric diet rich in iron, vitamin C and folate and iron supplement for 12 weeks.
Intervention Type
Combination Product
Intervention Name(s)
combination of aerobic exercise and healthy diet
Intervention Description
The 30 patients in this group will receive iron supplements, a personalized low caloric diet therapy based on Harris-Benedict equation. A restricted balanced diet will be prescribed which will be included. Perform aerobic exercise in the form of walking on electrical treadmill three times/ week day after day for 12 weeks according to following parameters. Type: moderate treadmill aerobic exercise Time: 40 minutes (5 minutes warm up phase, 30 minutes target heart rate (THR) phase, 5 minutes cooling down phase) Intensity: THR will be at 75% of maximum heart rate (which will be determined by submaximal graded exercise test and predicated MHR=220-age) Frequency: three times per week for 12 weeks
Primary Outcome Measure Information:
Title
BMI in kg/m2
Description
The anthropometric measurements will be detected via the in body scale. BMI (kg/m2) will be measured for all participants by dividing each participant's body weight (kg) by their heights (m2). Further, WC will be estimated during full expiration using an elastic tape midway between the last rib and the upper iliac crest border.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
RBCs in cells/ml
Description
Blood sample analysis to show the hematological measurements level, each participant will be asked to lie in half- lying position, with well supported back and arms. The antecubital area will be cleaned with alcohol. Blood sample will be drawn from the brachial vein from all participants by disposable sterile syringe.
Time Frame
3 months
Title
HB in g/dl
Description
blood sample analysis
Time Frame
3 months
Title
MCV in fl/cell
Description
blood sample analysis
Time Frame
3 months
Title
MCH in pg/cell
Description
blood sample analysis
Time Frame
3 months
Title
MCHC in g/dl
Description
blood sample analysis
Time Frame
3 months
Title
RDW in %
Description
blood sample analysis
Time Frame
3 months
Title
WBCs /mm3
Description
blood sample analysis
Time Frame
3 months
Title
Platelets count /mm3
Description
blood sample analysis
Time Frame
3 months
Title
serum ferritin in ng/ml
Description
blood sample analysis
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
all participants are married women with normal menstrual cycle
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age will ranges from 30 to 40 years. 2. BMI will ranges from 30 to 34.9 kg/m2 3. Hemoglobin level will ranges from 8 to 11 g/dl. 4. All of participants suffer from iron deficiency anemia. 5. Same level of physical activity according to physical activity index. 6. Same level of education and income. Exclusion Criteria: 1. Cognitive impairment that prevents participants from performing the evaluations and who are unable to understand and sign the written informed consent. 2. Hypertension. 3. diabetes mellitus 4. Disabling musculoskeletal disorder. 5. Patients with coronary artery disease or heart failure 6. Peripheral vascular disease in lower limb as deep venous thrombosis. 7. Stroke and bone disease, renal, liver, endocrinal disorders, cancer, or chemotherapy. 8. Different types of anemia. 9. Worms' affection. 10. Pregnancy and lactation. 11. Vitamins deficiency. 12. Six months post large surgeries.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
metwally
Phone
01020670619
Email
drsalmaelshafie@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
marwa daoud, master
Phone
01156033818
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gehan elmeniawy
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Dokki
State/Province
Giza
ZIP/Postal Code
12511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
metwally
Phone
01020670619
Email
drsalmaelshafie@gmail.com
First Name & Middle Initial & Last Name & Degree
marwa daoud

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
sharing study protocols with other researchers
IPD Sharing Time Frame
5 years after completion
IPD Sharing Access Criteria
publishing journal
IPD Sharing URL
http://Scholar.cu.edu.eg/p_t

Learn more about this trial

Effect of Aerobic Exercise and Diet on Anthropometric and Hematological Measurements in Obese Anemic Women

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