Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women

Not Applicable

Recruiting

• Conditions: Diabetes; Elderly

• Registration Number: NCT06724744
• Lead Sponsor: Cairo University

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).

Study Timeline

• Study Start: 2024-09-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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).
• Smokers.
• Rheumatoid arthritis.
• Musculoskeletal/ neurological limitations to exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilatory functions	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 Outcome Measures

Name	Time	Method
Functional capacity	At baseline and after 12 weeks	Cardiopulmonary exercise test will be conducted for all women at baseline and post-study based on the guidelines set by the American College of Sports Medicine to determine maximal oxygen consumption for each women.

Trial Locations

Locations (1)

Endocrinology outpatient clinic at Mansoura University; 🇪🇬 Mansoura, Dakahlya, Egypt