NCT05448235

Brief Summary

the study aims to investigate effectiveness of thoracic cage mobilizations on the chronic obstructive pulmonary diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

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 22, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

June 22, 2022

Last Update Submit

February 15, 2023

Conditions

Keywords

Thoracic cage mobilizationconventional treatment

Outcome Measures

Primary Outcomes (2)

  • ABG

    to measure pH (7.35-7.45), PaO2 (75-100 mmHg), PaCO2 (35-45 mmHg), HCO3 (22-26 meq/L) and SaO2 (95-100%) we will measure these types of ABG Before and after the treatment and measure the difference before and after and compared it with the standard to detect the effect of the treatment on the lung function

    up for one week

  • chest expansion with tape measurement

    using tape to measure chest exp ansion during inspiration and expiration at axillary level and at the level of T10 using CM units

    up for one week

Secondary Outcomes (2)

  • CAT questionnaire

    up for one week

  • Dyspnea index

    up for one week

Study Arms (2)

conventional treatment

EXPERIMENTAL

the patient will receive conventional treatment daily for up to one week

Other: conventional treatment

thoracic cage mobilization

EXPERIMENTAL

the patient will receive thoracic cage mobilization added to conventional treatment daily for up to one week

Other: conventional treatmentOther: thoracic mobilization

Interventions

the patient will be asked to make pursed lip breathing (Breathe in for 2 seconds through his nose and Breathe out for 4 seconds through pursed lips)for 5-10 min ,3-4 times , 8-10 rep each cycle then asked to make diaphragmatic breathing exercise (Lie on his/her back and Inhale deeply through his/her nose for a count of three)for 5-10 min , 3-4 times , 8-10 repetition then postural drainage , furthermore the patient takes different position (prone to make percussion on lower lobes, side lying on anterior basal segment then sitting position on the upper lobe). After that a vibration on the chest (place a flat hand firmly atop the lung segment to be drained., and should apply light pressure and create a rapid, shaking movement) 1 min inhale and 5 time of repetition at the exhale and finally asked the patient to make productive cough for 5 times to get out the sputum.

conventional treatmentthoracic cage mobilization

we will use A SNAG to mobilization using type 3 oscillatory and sustain for 90 second, at first put the patient in 3 position (side lying to make mobilization of upper 6 ribs in downward direction then make on lower 6 ribs ,furthermore flexion of the thoracic and next rotation toward the midline then ask the patient to transfer to supine lying position and mobilize the sternum in downward direction the next mobilize the clavicle and ask the patient to take sitting position and put his hand on his head in adduction position and make extension on the thoracic vertebrae with inward mobilize with the investigator knees ,take each 4 vertebrae along the 12 thoracic vertebrae.

thoracic cage mobilization

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic obstructive pulmonary disease.
  • Age \>35 years.
  • Received conventional medical treatment.
  • the presence of at least two of the following three clinical criteria: a recent increase in breathlessness, sputum volume or sputum purulence.
  • All enrolled patients either had previously been given a diagnosis of COPD by a physician or had at least a one-year history of chronic breathlessness or cough with sputum production

You may not qualify if:

  • Admitted to the hospital, had been given a diagnosis of asthma or atrophy.
  • Patients who had received oral or intravenous corticosteroid in the emergency department within the preceding 30 days.
  • patient put on the mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariam omran Grase

Giza, 12511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the patients , care provider and investigator do not know the groups receive treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: comparison between two groups one receive conventional treatment and other receives conventional treatment and thoracic mobilization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 7, 2022

Study Start

October 21, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations