Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women

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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Elderly
• Intervention / Treatment: Other: Aerobic training; Other: Manual Diaphragm Release

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed Sayed Saif, Ph.D
• Study Contact Backup: Name: Saad Mohamed Elgendy, Ph.D; Phone Number: +201020429911; Email: saherelgayar@yahoo.com

Study Locations

• Egypt
  • Dakahlya
    • Mansoura, Dakahlya, Egypt, 11831
      • Recruiting
      • Endocrinology outpatient clinic at Mansoura University
      • Contact: Hossam Arafa Ghazi, PhD; Phone Number: 00201281064314; Email: selgayar@meu.edu.jo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual diaphragmatic release group; 30 elderly diabetic women participating in manual diaphragmatic release plus aerobic training	Other: Aerobic training; For twelve weeks, the women participate in aerobic training on cycle ergometer. Each session consists of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session ends with a brief 3-minute period of cool-down.; Other: Manual Diaphragm Release; The participant is asked assume a supine position with relaxed limbs. The therapist should position themselves at the head of the participant and make manual contact with the pisiform, hypothenar region, and the last three fingers on both sides, underneath the seventh to tenth rib costal cartilages. The therapist's forearms should be aligned towards the participant's shoulders. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. Therapist progressively increases the depth of their contact within the costal margin.
Active Comparator: Control group; 30 elderly diabetic women participating in aerobic training only	Other: Aerobic training; For twelve weeks, the women participate in aerobic training on cycle ergometer. Each session consists of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session ends with a brief 3-minute period of cool-down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilatory functions	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.	At baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	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.	At baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Saher Lotfy Elgayar, Ph.D, Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University Amman Jordan

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 10, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Manual Diaphragmatic Release

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No