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

NCT05165680 | Unknown

• 1 other identifier: P.T.REC/012/003337
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (9)

• RBCs in cells/ml

  3 months

• HB in g/dl

  3 months

• MCV in fl/cell

  3 months

• MCH in pg/cell

  3 months

• MCHC in g/dl

  3 months

Study Arms (2)

experimental group, group A

EXPERIMENTAL

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.

Combination Product: combination of aerobic exercise and healthy diet

healthy diet

ACTIVE COMPARATOR

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

Combination Product: combination of aerobic exercise and healthy diet

Interventions

combination of aerobic exercise and healthy diet 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

experimental group, group A; healthy diet

Eligibility Criteria

• Age: 30 Years - 40 Years
• Gender Eligibility Details: all participants are married women with normal menstrual cycle
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Cognitive impairment that prevents participants from performing the evaluations and who are unable to understand and sign the written informed consent.
• \. 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.
• \. Different types of anemia. 9. Worms' affection. 10. Pregnancy and lactation. 11. Vitamins deficiency. 12. Six months post large surgeries.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Dokki, Giza Governorate, 12511, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity; Anemia, Iron-Deficiency

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• gehan elmeniawy

  Cairo University

  STUDY CHAIR

Central Study Contacts

metwally

CONTACT

01020670619; drsalmaelshafie@gmail.com

marwa daoud, master

CONTACT

01156033818

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded as neither the subjects nor the investigators are aware of the treatment assignment until the end of the trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapy practitioner

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: December 21, 2021
• Study Start: July 3, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years after completion
• Access Criteria: publishing journal

Locations

EG (1)