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Effect of Baduanjin Exercise on Chronic Periodontal Disease in Elderly

Primary Purpose

Chronic Periodontal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Baduanjin training/exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontal Disease

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercised group

control group

Arm Description

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 receive no training

Outcomes

Primary Outcome Measures

Periodontal disease index
it will assess periodontal health status

Secondary Outcome Measures

Simplified oral hygiene index
it will assess oral hygiene/cleanliness status
Interleukin 1 beta
it will be assessed in saliva
interleukin 6
it will be assessed in saliva
superoxide dismutase
it will be assessed in saliva
total antioxidant status
it will be assessed in saliva

Full Information

First Posted
July 30, 2022
Last Updated
December 22, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05484479
Brief Title
Effect of Baduanjin Exercise on Chronic Periodontal Disease in Elderly
Official Title
Baduanjin-exercise Efficacy on Chronic Periodontal Disease in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 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
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.
Detailed Description
For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be involved in sixty-minute Baduanjin physical training (5 session weekly). Also, for 6 months, another MeTS elderly (25 elderly) with chronic periodontal disease will serve as a control non-trained group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercised group
Arm Type
Experimental
Arm Description
For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be trained using sixty-minute Baduanjin training/exercise (5 times weekly)
Arm Title
control group
Arm Type
No Intervention
Arm Description
For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will receive no training
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin training/exercise
Intervention Description
For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be trained using sixty-minute Baduanjin training/exercise (5 times weekly)
Primary Outcome Measure Information:
Title
Periodontal disease index
Description
it will assess periodontal health status
Time Frame
It will be assessed after 6-month intervention
Secondary Outcome Measure Information:
Title
Simplified oral hygiene index
Description
it will assess oral hygiene/cleanliness status
Time Frame
It will be assessed after 6-month intervention
Title
Interleukin 1 beta
Description
it will be assessed in saliva
Time Frame
It will be after 6-month intervention
Title
interleukin 6
Description
it will be assessed in saliva
Time Frame
It will be assessed after 6-month intervention
Title
superoxide dismutase
Description
it will be assessed in saliva
Time Frame
It will be assessed after 6-month intervention
Title
total antioxidant status
Description
it will be assessed in saliva
Time Frame
It will be assessed after 6-month intervention

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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Effect of Baduanjin Exercise on Chronic Periodontal Disease in Elderly

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