NCT04928729

Brief Summary

  1. 1.To determine the Effects of combined pursed lip breathing with diaphragmatic breathing on pulmonary functions in patient with COPD.
  2. 2.To determine the different durations of combined pursed lip breathing with diaphragmatic breathing on Pulmonary functions in patient with COPD.
  3. 3.To determine the Effects of combined pursed lip breathing with diaphragmatic breathing on quality of life in patient with COPD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

June 14, 2021

Last Update Submit

October 19, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • COPD Assessment Test (CAT)

    The COPD Assessment Test (CAT) is a questionnaire for patients with chronic obstructive pulmonary disease (COPD), which can be filled in to quantify their symptoms in the form of scores (0-40). Changes From the Baseline will be Assessed. It is categorized into four groups, that are, low(1) , medium(2), high(3) and very high(4) based on the level of effect of the disease on status of health.

    6th week

  • Forced Expiratory Volume in 1 second (FEV1)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

    6th week

  • Forced vital Capacity (FVC)

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.

    6th Week

  • Peak Expiratory Flow (PEF)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.

    6th Week

  • 6 min walk test: Distance (meters)

    Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.

    6th week

  • Modified Borg Scale of Perceived Exertion

    Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.

    6th week

Study Arms (3)

Pursed Lip Breathing

EXPERIMENTAL
Other: Pursed Lip Breathing

Pursed Lip Breathing +DB

EXPERIMENTAL
Other: Pursed Lip Breathing +DB

Conservative care

EXPERIMENTAL
Other: Conservative care

Interventions

PLB with frequency of three times daily for First 3 days of week for a duration of 5-10 mins is perform.

Pursed Lip Breathing

PLB+DB with frequency of three times daily for Last three days of week for a duration of 10-15 mins is perform.

Pursed Lip Breathing +DB

Participants will be having different dose as per tolerance 5 times daily.

Conservative care

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were diagnosed as COPD
  • The intervention PLB Combine with DB
  • Stable COPD Patients (Mild and Moderate on GOLD criteria) Global Initiative for Chronic Obstructive Lung Disease (GOLD)

You may not qualify if:

  • Patients with other Pulmonary diseases.
  • cardiovascular, neurological and orthopedic diseases
  • Obesity, history of recent exacerbation
  • Uncontrolled arterial hypertension
  • Any surgical complications
  • Patients with ventilatory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonology Department of DHQ Teaching Hospital

Dera Ghazi Khan, Punjab Province, Pakistan

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 Officials

  • Muhammad Iqbal Tariq, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

June 14, 2021

First Posted

June 16, 2021

Study Start

October 15, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations