NCT05484479

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.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

July 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

July 30, 2022

Last Update Submit

December 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Periodontal disease index

    it will assess periodontal health status

    It will be assessed after 6-month intervention

Secondary Outcomes (5)

  • Simplified oral hygiene index

    It will be assessed after 6-month intervention

  • Interleukin 1 beta

    It will be after 6-month intervention

  • interleukin 6

    It will be assessed after 6-month intervention

  • superoxide dismutase

    It will be assessed after 6-month intervention

  • total antioxidant status

    It will be assessed after 6-month intervention

Study Arms (2)

Exercised group

EXPERIMENTAL

For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be trained using sixty-minute Baduanjin training/exercise (5 times weekly)

Behavioral: Baduanjin training/exercise

control group

NO INTERVENTION

For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will receive no training

Interventions

For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be trained using sixty-minute Baduanjin training/exercise (5 times weekly)

Exercised group

Eligibility Criteria

Age65 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • fifty elderly with metabolic syndrome and chronic periodontal disease will be included
  • both sexes will be included

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

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 Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

July 30, 2022

First Posted

August 2, 2022

Study Start

October 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations