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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06724744
Enrollment
60
Registered
2024-12-09
Start date
2024-09-15
Completion date
2025-02-10
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Elderly

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).

Interventions

OTHERAerobic 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.

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
65 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ventilatory functionsAt baseline and after 12 weeksVentilatory 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

MeasureTime frameDescription
Functional capacityAt baseline and after 12 weeksCardiopulmonary 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.

Countries

Egypt

Contacts

Primary ContactSaad Mohamed Elgendy, Ph.D
saherelgayar@yahoo.com+201020429911
Backup ContactMohammed Sayed Saif, Ph.D

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026