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

NCT ID: NCT05165680

Last Updated: 2021-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-03
• Study Completion Date: 2022-02-01

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.

Conditions

Obesity; Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

experimental group, group A

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.

Group Type: EXPERIMENTAL

combination of aerobic exercise and healthy diet

Intervention Type: COMBINATION_PRODUCT

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

healthy diet

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

Group Type: ACTIVE_COMPARATOR

combination of aerobic exercise and healthy diet

Intervention Type: COMBINATION_PRODUCT

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

Interventions

combination of aerobic exercise and healthy diet

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

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Salma Nabil Fathy Ahmed

physical therapy practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

gehan elmeniawy

Role: STUDY_CHAIR

Cairo University

Locations

Faculty of Physical Therapy, Cairo University

Dokki, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

metwally

Role: CONTACT

Phone: 01020670619

Email: drsalmaelshafie@gmail.com

marwa daoud, master

Role: CONTACT

Phone: 01156033818

Facility Contacts

metwally

Role: primary

marwa daoud

Role: backup

Other Identifiers

P.T.REC/012/003337

Identifier Type: -

Identifier Source: org_study_id