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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455033
Other study ID # Manual Diaphragm Release
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2024
Est. completion date May 15, 2025

Study information

Verified date June 2024
Source Beni-Suef University
Contact Mohammed Yo Elhamrawy, Ph.D
Phone +201282805567
Email dr_melhamrawy@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Finding the effect of diaphragm release exercises on stepping reaction time and balance in patients with chronic obstructive pulmonary disease patients.


Description:

Sixty patients with Chronic Obstructive Pulmonary Disease (COPD) will be randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be 55 years and above with history of COPD. The Ex group will attend 4 sessions/week of Manual Diaphragm Release Technique Combined with Deep Breathing (10:15-min) for 8 weeks, the CON will attend 4 sessions/week of Deep Breathing (10:15-min) for 8 weeks. The stepping reaction time will be assessed by the choice stepping reaction time (CSRT). The Balance will be determined using a Time up and Go test (TUG) an d Berg balance scale (BBS). All the outcomes will be examined at baseline, and 8 weeks of the intervention.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date May 15, 2025
Est. primary completion date March 15, 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years to 70 Years
Eligibility Inclusion Criteria: - All participants with a history of COPD - Adults ranging from 55- 70 years old of both genders. - Medically stable Exclusion Criteria: - Obesity (BMI = 30 kg/m2) - History of Pneumonia - Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm. - History of Myocardial infarction and/or cardiothoracic surgery - orthopedics, or neurological that may interfere the intervention. - Visual impairments, vestibular disorders, and postural hypotension. - Dementia that interferes with the ability to follow instructions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Manual Diaphragm Release Technique
The participant will 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. During exhalation, the therapist deepens their contact towards the inner costal margin while maintaining resistance. As the respiratory cycles continues, the therapist progressively increases the depth of their contact within the costal margin.
Breathing Exercise
Sit up straight in a chair lengthen the distance between your navel and sternum. Keep your shoulders relax. Keep the pelvis in neutral position (Sit on your sitting bones). Place your hands at either side of your lower ribs. Breath in slowly through your nose. As you inhale feel your ribs expanding outwards and upwards. During inhalation is generated expansion of the trunk in three directions front , sides and back. Breath out from your nose. As you exhale feel your lower ribs moving inwards.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Outcome

Type Measure Description Time frame Safety issue
Primary stepping reaction time stepping reaction time will be assessed by choice stepping reaction time test. The test procedure is as follows: when the stepping target is illuminated in a random order, the subject steps onto the illuminated target as quickly as possible.4 The faster the reaction, the shorter the reaction time. up to 8 weeks
Primary Balance Balance Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score < 10 seconds = normal < 20 seconds = good mobility; can walk outside alone; does not require a walking aid < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid. up to 8 weeks
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