NCT06966063

Brief Summary

A heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction. Breathing exercises help to manage dyspnea and reduced pulmonary function often seen in COPD patients. To handle respiratory complications COPD patients are advised to practice breathing techniques in conjunction with their prescribed medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

Study Start

First participant enrolled

June 15, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

May 2, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Dyspneapulmonary functionquality of life

Outcome Measures

Primary Outcomes (3)

  • Dyspnea

    Evaluation will be done using Dyspnea-12 questionnaire for dyspnea

    4 weeks

  • pulmonary function

    spirometer to measure volume of air inspired and exhale through lungs.

    4 weeks

  • Quality of Life of COPD patients

    COPD assessment test (CAT) will be used to evaluate quality of life of COPD patients

    4 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

Patients in interventional group will recieve 4-7-8 breathing along with standard management. For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time. Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. A home diary will be provided in order to ensure and follow-up that participants are performing breathing exercise at home along with medications prescribed by pulmonologist.

Procedure: 4-7-8 breathing along with standard management.

Control group

ACTIVE COMPARATOR

Patients will receive medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity. Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken. Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist.

Procedure: Control Group

Interventions

For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time. Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. Week 01 and 02 Frequenc: 01 session/day Intensity: Start with comfortable duration. Time: 10 minutes Week 03 and 04 Frequecy: 02 sessions/day Intensity: 4 sec inhale, 7 sec hold and 8 sec exhale Time: 15 minutes

Interventional group
Control GroupPROCEDURE

Patients will recieve medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity. Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken. Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist.

Control group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults: aged (40-64 years)
  • Gender: Both males and females
  • Grade1- Grade 1-3 on Modified MRC dyspnea scale
  • COPD mild and moderate according to GOLD classification
  • Mild: FEV1 \> 80% predicted
  • Moderate: FEV1 \>50% predicted

You may not qualify if:

  • Severe and very severe stage of COPD according to GOLD classification.
  • Patients having Acute exacerbation of COPD.
  • Patients diagnosed with acute infections.
  • Patients unable to follow commands/ instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

June 15, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations