- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484479
Effect of Baduanjin Exercise on Chronic Periodontal Disease in Elderly
Baduanjin-exercise Efficacy on Chronic Periodontal Disease in Elderly
The metabolic syndrome (MetS) is a spectrum of conditions that increase the risk of cardiovascular disease and diabetes mellitus. The components of MetS include dysglycemia, visceral obesity, atherogenic dyslipidemia (elevated triglycerides and low levels of high-density lipoprotein) and hypertension. An association of periodontal disease and MetS has been suggested. This association is believed to be the result of systemic oxidative stress and an exuberant inflammatory response.
Physical activity is associated as a potential tool for reduction of periodontal disease prevalence. The frequency of physical activity is directly related to a low occurrence of periodontitis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt
- Recruiting
- Faculty of Physical Therapy Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- fifty elderly with metabolic syndrome and chronic periodontal disease will be included
- both sexes will be included
Exclusion Criteria:
- smokers
- elderly engaged in physical activity programs
- any cardiovascular/respiratory diseases that obstacle the conduction of Baduanjin
- elderly on drug therapies for chronic periodontal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercised group
For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be trained using sixty-minute Baduanjin training/exercise (5 times weekly)
|
For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be trained using sixty-minute Baduanjin training/exercise (5 times weekly)
|
|
No Intervention: control group
For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will receive no training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Periodontal disease index
Time Frame: It will be assessed after 6-month intervention
|
it will assess periodontal health status
|
It will be assessed after 6-month intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simplified oral hygiene index
Time Frame: It will be assessed after 6-month intervention
|
it will assess oral hygiene/cleanliness status
|
It will be assessed after 6-month intervention
|
|
Interleukin 1 beta
Time Frame: It will be after 6-month intervention
|
it will be assessed in saliva
|
It will be after 6-month intervention
|
|
interleukin 6
Time Frame: It will be assessed after 6-month intervention
|
it will be assessed in saliva
|
It will be assessed after 6-month intervention
|
|
superoxide dismutase
Time Frame: It will be assessed after 6-month intervention
|
it will be assessed in saliva
|
It will be assessed after 6-month intervention
|
|
total antioxidant status
Time Frame: It will be assessed after 6-month intervention
|
it will be assessed in saliva
|
It will be assessed after 6-month intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003757
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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