search
Back to results

Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters

Primary Purpose

Iron Deficiency Anemia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Yuga
Aerobic exercises
Sponsored by
Shokry Mahmoud Youssef Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

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

Inclusion Criteria: Sixty female patients referred with iron deficiency anemia Their age will be ranged from 30-40 years old. All patients have a history of anemia. All patients should be medically stable. The body mass index (BMI) ranged from 25:29.9 Kg/m2 Number of parity not exceed 3 times. Period of menses from 3-5 days Exclusion Criteria: Patients with cognitive impairments. All types of anemia except iron deficiency anemia patients with hearing problems. patients with Diabetes, Hypertension. Patients with Musculoskeletal, Neurological, Cardiovascular and Respiratory problems patients with mental problems.

Sites / Locations

  • October 6 universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group (I)

Group (II)

Arm Description

consists of 30 patients with iron deficiency anemia and will receive medical treatment of anemia, Dietary advices and 50 minutes yoga therapy 6 days a week for 12 weeks

consists of 30 patients with iron deficiency anemia and will receive medical treatment for anemia, Diet advices and 30 minutes of aerobic exercises in form of treadmill according to the target exercise heart rate for 12 weeks.

Outcomes

Primary Outcome Measures

serum iron level
it will be measured in serum from complete blood picture. Reference range from 50 till 212 ug/dl. Number of participants are 60 females.
ferritin level
it will be measured in serum from iron profile. Reference range from 10 till 158 ng/ml. Number of participants are 60 females.
iron binding capacity level
it will be measured in serum from iron profile. Reference range from 250 till 400 ug/dl. Number of participants are 60 females.
count of red blood cells
it will be measured in serum from complete blood picture. Reference range from 3.80 till 4.80 million cell/cmm. Number of participants are 60 females.
Hemoglobin level
it will be measured in serum from complete blood . picture. Reference range from 12 till 15 g/dl. Number of participants are 60 females.
hematocrite level
it will be measured in serum from complete blood picture. Reference range from 36% till 45%. Number of participants are 60 females.
lymphocytes level
it will be measured in serum from differential white cell count. Reference range absolute from 1000 till 4000 and relative from 20% till 45%. Number of participants are 60 females.

Secondary Outcome Measures

six minute walking distance
The six minute walking distance is measured using six Minute Walk Test which is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The tools are used include 30 meters corridor,2 cones,stopwatch,chair,mechanical lap counter and sphygmomanometer Number of participants are 60 females.
The fatigue severity scale(FSS)
The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician. Number of participants are 60 females.

Full Information

First Posted
June 27, 2023
Last Updated
August 27, 2023
Sponsor
Shokry Mahmoud Youssef Mohamed
search

1. Study Identification

Unique Protocol Identification Number
NCT05949437
Brief Title
Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters
Official Title
The Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters in Iron Deficiency Anemic Females
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shokry Mahmoud Youssef Mohamed

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
Is there effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females? The purpose of the study is to investigate the effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females
Detailed Description
60 patients with iron deficiency anemia and will receive medical treatment of anemia and Dietary advice for 12 weeks . thirty patient from the 60 patients will receive yoga therapy and 50 minutes yoga therapy 6 days a week for 12 weeks while the other 30 patients will receive aerobic exercise for 12 weeks

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (I)
Arm Type
Experimental
Arm Description
consists of 30 patients with iron deficiency anemia and will receive medical treatment of anemia, Dietary advices and 50 minutes yoga therapy 6 days a week for 12 weeks
Arm Title
Group (II)
Arm Type
Other
Arm Description
consists of 30 patients with iron deficiency anemia and will receive medical treatment for anemia, Diet advices and 30 minutes of aerobic exercises in form of treadmill according to the target exercise heart rate for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Yuga
Intervention Description
Traditional yoga body posture for 15 minutes, yoga breathing exercises for 30 minutes and meditation for 5 minutes for 12 weeks
Intervention Type
Other
Intervention Name(s)
Aerobic exercises
Intervention Description
in form of treadmill according to the target exercise heart rate for 12 weeks
Primary Outcome Measure Information:
Title
serum iron level
Description
it will be measured in serum from complete blood picture. Reference range from 50 till 212 ug/dl. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Title
ferritin level
Description
it will be measured in serum from iron profile. Reference range from 10 till 158 ng/ml. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Title
iron binding capacity level
Description
it will be measured in serum from iron profile. Reference range from 250 till 400 ug/dl. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Title
count of red blood cells
Description
it will be measured in serum from complete blood picture. Reference range from 3.80 till 4.80 million cell/cmm. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Title
Hemoglobin level
Description
it will be measured in serum from complete blood . picture. Reference range from 12 till 15 g/dl. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Title
hematocrite level
Description
it will be measured in serum from complete blood picture. Reference range from 36% till 45%. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Title
lymphocytes level
Description
it will be measured in serum from differential white cell count. Reference range absolute from 1000 till 4000 and relative from 20% till 45%. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Secondary Outcome Measure Information:
Title
six minute walking distance
Description
The six minute walking distance is measured using six Minute Walk Test which is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The tools are used include 30 meters corridor,2 cones,stopwatch,chair,mechanical lap counter and sphygmomanometer Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks
Title
The fatigue severity scale(FSS)
Description
The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician. Number of participants are 60 females.
Time Frame
it will be measured after 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sixty female patients referred with iron deficiency anemia Their age will be ranged from 30-40 years old. All patients have a history of anemia. All patients should be medically stable. The body mass index (BMI) ranged from 25:29.9 Kg/m2 Number of parity not exceed 3 times. Period of menses from 3-5 days Exclusion Criteria: Patients with cognitive impairments. All types of anemia except iron deficiency anemia patients with hearing problems. patients with Diabetes, Hypertension. Patients with Musculoskeletal, Neurological, Cardiovascular and Respiratory problems patients with mental problems.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail, Phd
Phone
01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail
Phone
01005154209
Email
ali.mohamed@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shoukry MA youssef, ass lecturer
Organizational Affiliation
6 october University
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 university
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shokry Ms Youssef, Ass lecturer
Phone
01008111991
Email
drshokry2015@gmail.com
First Name & Middle Initial & Last Name & Degree
Hossam Mh Metwaly, Lecturer
Phone
01112730605
Email
hosammagdy40@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters

We'll reach out to this number within 24 hrs