ClinicalTrials.gg
Status unknownNCT06455033Updated Oct 15, 2024

Manual Diaphragm Release on Stepping Reaction Time in Chronic Obstructive Pulmonary Disease

An interventional study of Manual Diaphragm Release Technique and Breathing Exercise in Respiratory Disease, sponsored by Beni-Suef University. Status unknown at 1 site in Egypt. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
55 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Respiratory Disease

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03

In context

Respiration Disorders

520 studies on the registry are indexed under Respiration Disorders; 99 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 296 interventional studies indexed under Respiration Disorders.

Browse Respiration Disorders studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 337 studies on the registry; 114 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All participants with a history of COPD
  • Adults ranging from 55- 70 years old of both genders.
  • Medically stable

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Study Group

    30 patients with chronic obstructive pulmonary disease

    Other: Manual Diaphragm Release Technique · Other: Breathing Exercise

  • Active comparator
    Control group

    30 patients with chronic obstructive pulmonary disease

    Other: Breathing Exercise

Interventions

  • OtherManual 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.

  • OtherBreathing 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 8 weeks

  2. 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.

    Time frame: up to 8 weeks

07

Study locations

1 site
  • Kz Hospital
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Aug 2025, 11 months after the start.

Of 135 non-industry interventional studies with no phase under Respiration Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 11 months is below that.

Counting every sponsor, half of 158 studies reached it within 15 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2024
First posted
Jun 12, 2024
StartActual
Aug 22, 2024
Primary completionEst.
Aug 15, 2025
CompletionEst.
Nov 15, 2025
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06455033
Responsible party
Mohammed Youssef Elhamrawy (Lecturer of Physical therapy, Beni-Suef University) — Principal investigator
First posted
Jun 12, 2024
Start date
Aug 22, 2024
Primary completion
Aug 15, 2025 (estimated)
Completion
Nov 15, 2025 (estimated)
Last update
Oct 15, 2024

Study contacts

Mohammed S Saif, Ph.D
study director · National institute for Gerontology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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