Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women

NCT06724744 | Recruiting DMC

• 1 other identifier: Manual Diaphragmatic Release
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional capacity

  At baseline and after 12 weeks

Study Arms (2)

Manual diaphragmatic release group

ACTIVE COMPARATOR

30 elderly diabetic women participating in manual diaphragmatic release plus aerobic training

Other: Aerobic training; Other: Manual Diaphragm Release

Control group

ACTIVE COMPARATOR

30 elderly diabetic women participating in aerobic training only

Other: Aerobic training

Interventions

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.

Control group; Manual diaphragmatic release group

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.

Manual diaphragmatic release group

Eligibility Criteria

• Age: 65 Years - 70 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Endocrinology outpatient clinic at Mansoura University

Al Mansurah, Dakahlya, 11831, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Saher Lotfy Elgayar, Ph.D

  Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University Amman Jordan

  STUDY DIRECTOR

Central Study Contacts

Saad Mohamed Elgendy, Ph.D

CONTACT

+201020429911; saherelgayar@yahoo.com

Mohammed Sayed Saif, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: September 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 10, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)