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Clinical Trials/NCT06724744
NCT06724744
Recruiting
Not Applicable

Effect of Manual Diaphragmatic Release on Ventilatory Functions and Functional Capacity in Elderly Diabetic Women

Cairo University1 site in 1 country60 target enrollmentSeptember 15, 2024
ConditionsDiabetesElderly

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Ventilatory functions
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women.

Detailed Description

Sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at Mansoura University hospitals in Egypt, with referrals from endocrinologists. Patients were randomly assigned into two groups. The study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes are assessed: 1. Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second). 2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).

Registry
clinicaltrials.gov
Start Date
September 15, 2024
End Date
February 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saad

Assistant Professor of Physical Therapy

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetic for more than 5 years.
  • Well controlled diabetes with glycated hemoglobin≤7%.
  • Normal to mild ventilatory functions impairment.
  • Their ages ranges from 65 to 70 years old.
  • Their body mass index are less than 30 Kg/m2.

Exclusion Criteria

  • Other types of diabetes.
  • Patients with any other chronic chest diseases .
  • Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
  • Rheumatoid arthritis.
  • Musculoskeletal/ neurological limitations to exercise.

Outcomes

Primary Outcomes

Ventilatory functions

Time Frame: At baseline and after 12 weeks

Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second are measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.

Secondary Outcomes

  • Functional capacity(At baseline and after 12 weeks)

Study Sites (1)

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