NCT05949437

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 29, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

June 27, 2023

Last Update Submit

August 27, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    it will be measured after 12 weeks

Secondary Outcomes (2)

  • six minute walking distance

    it will be measured after 12 weeks

  • The fatigue severity scale(FSS)

    it will be measured after 12 weeks

Study Arms (2)

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

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.

Other: Aerobic exercises

Interventions

YugaOTHER

Traditional yoga body posture for 15 minutes, yoga breathing exercises for 30 minutes and meditation for 5 minutes for 12 weeks

Group (I)

in form of treadmill according to the target exercise heart rate for 12 weeks

Group (II)

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • shoukry MA youssef, ass lecturer

    6 october University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of physical therapy for Internal Medicine and Geriatrics

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 18, 2023

Study Start

July 17, 2023

Primary Completion

December 1, 2023

Study Completion

December 30, 2023

Last Updated

August 29, 2023

Record last verified: 2023-07

Locations