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NCT Number: NCT06724744

Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women

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

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Key information

Conditions

Diabetes Diabetes Mellitus Elderly Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinology outpatient clinic at Mansoura University

Al Mansurah, Dakahlya, 11831, Egypt

Location status: Recruiting

Location contact

Hossam Arafa Ghazi, PhD

CONTACT

[email protected]

00201281064314

About this study

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:

  • Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second).
  • Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic training

Other

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.

Manual Diaphragm Release

Other

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.

Primary outcomes

  1. 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

  1. Functional capacity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Sayed Saif, Ph.D

CONTACT

Saad Mohamed Elgendy, Ph.D

CONTACT

[email protected]

+201020429911

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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