NCT04138069

Brief Summary

A randomized control trial was conducted at physiotherapy department of Pakistan Railway General Hospital from July 2017 to Dec 2017. 30 patients with stable COPD were enrolled in the study on the basis of inclusion and exclusion criteria. The participants were randomly assigned into two groups, Group A= interventional group, Group B = control group through toss and coin method using non-probability convenient sampling technique and written consent was obtained from each patient participated in the study. From 30 patients 15 patients were randomly allocated to each group, Group A: Interventional (n= 15), Group B: Control (n=15). 1 patient in control group B was dropout because he didn't come for follow up. Overall 29 patients were evaluated for study as in Group A, interventional (n=15) and Group B control (n=14).Patients in group A were performed breathing control at the start of session and then Purse lips breathing technique during aerobic bicycling for 8 min while in group B patients first perform breathing control and then aerobic bicycling for 8 min. Subjects in both experimental and control group underwent spirometry and baseline vitals, such as Respiratory rate, blood pressure, and oxygen saturation, at rest and at the completion of session was noted. Borg scale of dyspnea also used to rate the level of dyspnea at rest and at the end of session. Clinical COPD Questionnaire (CCQ) was used at 1st and final week of evaluation. It was 6 weeks training protocol, with three days per week session was given to the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

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

July 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

October 22, 2019

Last Update Submit

January 8, 2020

Conditions

Keywords

COPDPursed Lips BreathingDyspneaPulmonary Function Test (PFT)Aerobic Training

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Breathing Pattern

    6th weeks

Study Arms (2)

PLB+Aerobic Bicycling

EXPERIMENTAL

Pursed Lip Breathing + Aerobic Bicycling

Other: PLB+Aerobic Bicycling

Aerobic Bicycling

ACTIVE COMPARATOR

Only Aerobic bicycling

Other: Aerobic Bicycling

Interventions

Combination of Breathing control and Purse lips breathing technique for 5 minutes at the start of session. Purse lips breathing with aerobic bicycling for 8 minutes

PLB+Aerobic Bicycling

Breathing control for 5 minutes at the start of session. Aerobic bicycling for 8 minutes

Aerobic Bicycling

Eligibility Criteria

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

You may qualify if:

  • COPD stage 2 and 3 patients \[based on "Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria\]

You may not qualify if:

  • neurological disorder and
  • cardiovascular disorder
  • Impaired lower limbs mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

  • 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

October 22, 2019

First Posted

October 24, 2019

Study Start

July 1, 2017

Primary Completion

December 25, 2017

Study Completion

December 30, 2017

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations