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Recruiting NCT06724744

Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women

No phase Interventional Diabetes Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic training, Manual Diaphragm Release.
Who it may be relevant to
Registry conditions: Diabetes, Elderly. Basic parameters: 65 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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

Primary outcome measures

  • Ventilatory functions [Time frame: At baseline and after 12 weeks]
Secondary outcome measures (1)
  • Functional capacity [Time frame: At baseline and after 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Endocrinology outpatient clinic at Mansoura University — Al Mansurah

Identifiers

NCT: NCT06724744 · Manual Diaphragmatic Release

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗