Subclinical hypothyroïdismNCT05803967
Baduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems
A study testing Baduanjin exercising in people with Subclinical hypothyroïdism and Cognitive Impairment, run by Cairo University at 1 site in Egypt.
Trial summary
Females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly Read more about this study
- Who is it for?
- Ages 65 to 75 years, women only
- Conditions the study is for
- Subclinical hypothyroïdism, Cognitive Impairment
- What is being tested?
- Baduanjin exercising
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2022to 30 Jun 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 65 to 75 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- female with sub-clinical hypothyroidism
- females with mild cognitive impairment
- females with obesity (obesity class one)
Who cannot join
- neurological problems
- orthopedic problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
Official title: Baduanjin Exercising Effects on Women With Hypothyroidism and Cognitive Problems
Females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly
Read the 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).
- Conditions
- Subclinical hypothyroïdism, Cognitive Impairment
- Being tested
- Baduanjin exercising
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exercisingBehavioural
baduanjin will be applied 5 times per the week, under supervision, for 12 weeks,
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | 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). Receives: Behavioral: Baduanjin exercising |
| group number 2 | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid stimulating hormone
will be measured in serum of women with hypothyroidism
Measured: it will be measured after 12 weeks
Secondary outcomes (8)
systolic blood pressure
will be measured by manual sphygmomanometer
Measured: it will be measured after 12 weeks
triglycerides
will be measured in serum of women with hypothyroidism
Measured: it will be measured after 12 weeks
Addenbrooke Cognitive Examination
will assess Cognitive impairment
Measured: it will be measured after 12 weeks
diastolic blood pressure
will be measured by manual sphygmomanometer
Measured: it will be measured after 12 weeks
low density lipoprotein
will be measured in serum of women with hypothyroidism
Measured: it will be measured after 12 weeks
cholesterol
will be measured in serum of women with hypothyroidism
Measured: it will be measured after 12 weeks
high density lipoprotein
will be measured in serum of women with hypothyroidism
Measured: it will be measured after 12 weeks
body mass index
it will be measure on empty bladder and stomach
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 posted7 Apr 2023
- Study start18 Dec 2022
- Primary completion18 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical hypothyroïdismStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803967
- Sponsor's protocol ID
- P.T.REC/012/004294
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baduanjin Exercising Effects on Women With Hypothyroidism and Cognitive Problems
- ClinicalTrials.gov ID
- NCT05803967
- Acronym / sponsor ID
- P.T.REC/012/004294
- Conditions
- Subclinical hypothyroïdism, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Dec 2022 (actual)
- Primary completion
- 18 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 7 Apr 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: Baduanjin exercisingFemales 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). |
| group number 2 | No intervention | –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). |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- female with sub-clinical hypothyroidism
- females with mild cognitive impairment
- females with obesity (obesity class one)
Key exclusion criteria (2 listed)
- neurological problems
- orthopedic 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 |
|---|---|---|
| Baduanjin exercisingbaduanjin will be applied 5 times per the week, under supervision, for 12 weeks, | Behavioural | group number 1 |
Primary outcome
thyroid stimulating hormone
Time frame: it will be measured after 12 weeks
will be measured in serum of women with hypothyroidism
8 secondary outcomes
systolic blood pressure
Time frame: it will be measured after 12 weeks
triglycerides
Time frame: it will be measured after 12 weeks
Addenbrooke Cognitive Examination
Time frame: it will be measured after 12 weeks
diastolic blood pressure
Time frame: it will be measured after 12 weeks
low density lipoprotein
Time frame: it will be measured after 12 weeks
cholesterol
Time frame: it will be measured after 12 weeks
high density lipoprotein
Time frame: it will be measured after 12 weeks
body mass index
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 7 Apr 2023.
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Subclinical hypothyroïdism
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.
Ali MA Ismail principal investigator
Cairo 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 Baduanjin exercising in people with Subclinical hypothyroïdism and Cognitive Impairment, run by Cairo University 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 3 inclusion and 2 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 7 Apr 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 (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?
thyroid stimulating hormone (time frame: it will be measured after 12 weeks). 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 7 Apr 2023.