Back to resultsBaduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems
Primary Purpose
Subclinical hypothyroïdism, Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Baduanjin exercising
Sponsored by
About this trial
This is an interventional treatment trial for Subclinical hypothyroïdism
Eligibility Criteria
Inclusion Criteria: female with sub-clinical hypothyroidism females with mild cognitive impairment females with obesity (obesity class one) Exclusion Criteria: neurological problems orthopedic problems
Sites / Locations
- Cairo UnoversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
group number 1
group number 2
Arm Description
Females with sub-clinical hypothyroidism exhibit cognitive problems (mild cognitive impairement), they will be elderly, will receive baduanjin training that will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20), also women of this group will receive their prescribed daily one-dose medication tablet (levothyroxine).
Females with sub-clinical hypothyroidism exhibit cognitive problems (mild cognitive impairement), they will be elderly, will receive will receive their prescribed daily one-dose medication tablet (levothyroxine).
Outcomes
Primary Outcome Measures
thyroid stimulating hormone
will be measured in serum of women with hypothyroidism
Secondary Outcome Measures
systolic blood pressure
will be measured by manual sphygmomanometer
triglycerides
will be measured in serum of women with hypothyroidism
Addenbrooke Cognitive Examination
will assess Cognitive impairment
diastolic blood pressure
will be measured by manual sphygmomanometer
low density lipoprotein
will be measured in serum of women with hypothyroidism
cholesterol
will be measured in serum of women with hypothyroidism
high density lipoprotein
will be measured in serum of women with hypothyroidism
body mass index
it will be measure on empty bladder and stomach
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05803967
Brief Title
Baduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems
Official Title
Baduanjin Exercising Effects on Women With Hypothyroidism and Cognitive Problems
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2022 (Actual)
Primary Completion Date
June 18, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly
Detailed Description
Females (forty in number) with sub-clinical hypothyroidism exhibit cognitive problems, they are elderly, will be divided to exercised group (baduanjin training will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20) and other non exercised group (number of patients will be 20) . all women of groups will received their prescribed daily one-dose medication tablet (levothyroxine).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subclinical hypothyroïdism, Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group number 1
Arm Type
Experimental
Arm Description
Females with sub-clinical hypothyroidism exhibit cognitive problems (mild cognitive impairement), they will be elderly, will receive baduanjin training that will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20), also women of this group will receive their prescribed daily one-dose medication tablet (levothyroxine).
Arm Title
group number 2
Arm Type
No Intervention
Arm Description
Females with sub-clinical hypothyroidism exhibit cognitive problems (mild cognitive impairement), they will be elderly, will receive will receive their prescribed daily one-dose medication tablet (levothyroxine).
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin exercising
Intervention Description
baduanjin will be applied 5 times per the week, under supervision, for 12 weeks,
Primary Outcome Measure Information:
Title
thyroid stimulating hormone
Description
will be measured in serum of women with hypothyroidism
Time Frame
it will be measured after 12 weeks
Secondary Outcome Measure Information:
Title
systolic blood pressure
Description
will be measured by manual sphygmomanometer
Time Frame
it will be measured after 12 weeks
Title
triglycerides
Description
will be measured in serum of women with hypothyroidism
Time Frame
it will be measured after 12 weeks
Title
Addenbrooke Cognitive Examination
Description
will assess Cognitive impairment
Time Frame
it will be measured after 12 weeks
Title
diastolic blood pressure
Description
will be measured by manual sphygmomanometer
Time Frame
it will be measured after 12 weeks
Title
low density lipoprotein
Description
will be measured in serum of women with hypothyroidism
Time Frame
it will be measured after 12 weeks
Title
cholesterol
Description
will be measured in serum of women with hypothyroidism
Time Frame
it will be measured after 12 weeks
Title
high density lipoprotein
Description
will be measured in serum of women with hypothyroidism
Time Frame
it will be measured after 12 weeks
Title
body mass index
Description
it will be measure on empty bladder and stomach
Time Frame
it will be measured after 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity.
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female with sub-clinical hypothyroidism
females with mild cognitive impairment
females with obesity (obesity class one)
Exclusion Criteria:
neurological problems
orthopedic problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail
Phone
01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mona MA morsi
Phone
01006372646
Email
allooka2012@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali MA Ismail
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
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Baduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems
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