NCT05651958

Brief Summary

It will be randomized controlled trial. The research will be conducted at Bahawal Victoria hospital Bahawalpur and civil hospital Bahawalpur. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Group A will get conventional medical treatment and Group B will get both conventional medical treatment and pranayama breathing exercise. Both gender of age group 30 to 55, Patient with diagnosed Chronic obstructive pulmonary disease ,Moderate to severe Chronic obstructive pulmonary disease with productive cough, Shortness of breathe and no surgical procedure performed will be included in this study. And patients of lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

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

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

December 6, 2022

Last Update Submit

February 20, 2023

Conditions

Keywords

PranayamaCOPDDyspneaExercise tolerance

Outcome Measures

Primary Outcomes (3)

  • 6 min walk test.

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    Six Weeks

  • IPAQ- quality of life

    The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants.

    Six Weeks

  • VSAQ-exercise capacity

    The VSAQ, capturing patient-reported outcome measures, is an efficient and quantifiable measure of exercise capacity that can be readily employed in clinical services particularly where patients have normal to high exercise tolerance

    Six Weeks

Study Arms (2)

Pranayma Breathing Technique

EXPERIMENTAL

Pranayma Breathing Technique protocol includes 15 breaths in the morning and 15 breaths in evening for atleast weeks.

Other: Breathing Technique

Conventional Treatment

ACTIVE COMPARATOR

Long-acting beta-2 agonist, nebulizers and long acting anti-mucosic drugs.

Other: Nebulizer

Interventions

Active Comparator: Nebulization every 3 days with the other medicine to the active comparator.

Conventional Treatment

15 repeatations of Breathing in morning and evening

Pranayma Breathing Technique

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both gender of age group 30 to 55
  • Patient with diagnosed COPD.
  • Moderate to severe COPD.
  • Patient with productive cough and SOB.
  • No surgical procedure perform.

You may not qualify if:

  • Patient of lung surgery
  • Lung cancer patient
  • Patient above 70 years age.
  • Patient with open wound.
  • Patient with cardiovascular issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahawal Victoria Hospital and Civil Hospital

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

Nebulizers and Vaporizers

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)

Equipment and Supplies

Study Officials

  • madiha younas, MS

    riphah internationl university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 15, 2022

Study Start

February 1, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations