Iron Deficiency AnemiaNCT05949437
Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters
A study testing Yuga and Aerobic exercises in people with Iron Deficiency Anemia, run by Shokry Mahmoud Youssef Mohamed at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Yuga and Aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jul 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
October 6 university
Giza
Shokry Ms Youssef, Ass lecturer, 01008111991, drshokry2015@gmail.com
Hossam Mh Metwaly, Lecturer, 01112730605, hosammagdy40@yahoo.com
About this study
Official title: The Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters in Iron Deficiency Anemic Females
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
Read the 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
- Conditions
- Iron Deficiency Anemia
- Being tested
- Yuga, Aerobic exercises
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YugaOther
Traditional yoga body posture for 15 minutes, yoga breathing exercises for 30 minutes and meditation for 5 minutes for 12 weeks
Aerobic exercisesOther
in form of treadmill according to the target exercise heart rate for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group (I) | Experimental | 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 Receives: Other: Yuga |
| Group (II) | Other | 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. Receives: Other: Aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: it will be measured after 12 weeks
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.
Measured: it will be measured after 12 weeks
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.
Measured: it will be measured after 12 weeks
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.
Measured: it will be measured after 12 weeks
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.
Measured: it will be measured after 12 weeks
hematocrite level
it will be measured in serum from complete blood picture. Reference range from 36% till 45%. Number of participants are 60 females.
Measured: it will be measured after 12 weeks
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.
Measured: it will be measured after 12 weeks
Secondary outcomes (2)
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.
Measured: it will be measured after 12 weeks
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.
Measured: it will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start17 Jul 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shokry Mahmoud Youssef Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shokry Mahmoud Youssef Mohamed, October 6 University
- Investigators
- shoukry MA youssef, ass lecturer, Principal investigator, 6 october University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949437
- Sponsor's protocol ID
- P.T.REC/012/004556
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters in Iron Deficiency Anemic Females
- ClinicalTrials.gov ID
- NCT05949437
- Acronym / sponsor ID
- P.T.REC/012/004556
- Conditions
- Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shokry Mahmoud Youssef MohamedUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (I) | Experimental | Other: Yugaconsists 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 |
| Group (II) | Other | Other: Aerobic exercisesconsists 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. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YugaTraditional yoga body posture for 15 minutes, yoga breathing exercises for 30 minutes and meditation for 5 minutes for 12 weeks | Other | Group (I) |
| Aerobic exercisesin form of treadmill according to the target exercise heart rate for 12 weeks | Other | Group (II) |
Primary outcome
serum iron level
Time frame: it will be measured after 12 weeks
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
Time frame: it will be measured after 12 weeks
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
Time frame: it will be measured after 12 weeks
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
Time frame: it will be measured after 12 weeks
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
Time frame: it will be measured after 12 weeks
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
Time frame: it will be measured after 12 weeks
it will be measured in serum from complete blood picture. Reference range from 36% till 45%. Number of participants are 60 females.
lymphocytes level
Time frame: it will be measured after 12 weeks
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.
2 secondary outcomes
six minute walking distance
Time frame: it will be measured after 12 weeks
The fatigue severity scale(FSS)
Time frame: it will be measured after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shoukry MA youssef, ass lecturer principal investigator
6 october University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yuga and Aerobic exercises in people with Iron Deficiency Anemia, run by Shokry Mahmoud Youssef Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, Phd (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum iron level (time frame: it will be measured after 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.