NCT05803967

Brief Summary

Females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

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

Study Start

First participant enrolled

December 18, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 27, 2023

Last Update Submit

March 27, 2023

Conditions

Subclinical hypothyroïdismCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • thyroid stimulating hormone

    will be measured in serum of women with hypothyroidism

    it will be measured after 12 weeks

Secondary Outcomes (8)

  • systolic blood pressure

    it will be measured after 12 weeks

  • triglycerides

    it will be measured after 12 weeks

  • Addenbrooke Cognitive Examination

    it will be measured after 12 weeks

  • diastolic blood pressure

    it will be measured after 12 weeks

  • low density lipoprotein

    it will be measured after 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

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).

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).

Interventions

Baduanjin exercisingBEHAVIORAL

baduanjin will be applied 5 times per the week, under supervision, for 12 weeks,

group number 1

Eligibility Criteria

Age65 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • female with sub-clinical hypothyroidism
  • females with mild cognitive impairment
  • females with obesity (obesity class one)

You may not qualify if:

  • neurological problems
  • orthopedic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Ali MA Ismail

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

mona MA morsi

CONTACT

01006372646allooka2012@yahoo.com

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
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Internal Medicine and Geriatrics

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

December 18, 2022

Primary Completion

June 18, 2023

Study Completion

June 30, 2023

Last Updated

April 7, 2023

Record last verified: 2023-03

Locations

EG(1)