NCT06455033

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 22, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

October 15, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 7, 2024

Last Update Submit

October 11, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Study Group

ACTIVE COMPARATOR

30 patients with chronic obstructive pulmonary disease

Other: Manual Diaphragm Release TechniqueOther: Breathing Exercise

Control group

ACTIVE COMPARATOR

30 patients with chronic obstructive pulmonary disease

Other: Breathing Exercise

Interventions

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.

Study Group

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.

Control groupStudy Group

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kz Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Respiration Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Mohammed S Saif, Ph.D

    National institute for Gerontology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical therapy

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 12, 2024

Study Start

August 22, 2024

Primary Completion

August 15, 2025

Study Completion

November 15, 2025

Last Updated

October 15, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations