NCT05538975

Brief Summary

Chronic obstructive pulmonary disease (COPD)is a multifactorial, progressive chronic lung disease that causes airflow restriction. Study was conducted To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients of chronic obstructive pulmonary disease.

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 Feb 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

September 8, 2022

Last Update Submit

September 12, 2022

Conditions

COPDPulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • Six minute walk test

    to measure distance walked in six minutes

    6 months

  • Cough & sputum assessment questionnaire.

    recall assesses the frequency and severity of cough and sputum and their impact on everyday life

    6 months

Secondary Outcomes (1)

  • leicester cough questionnaire

    6 months

Study Arms (2)

Group A

EXPERIMENTAL

home based plan of aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing

Other: Physiotherapy Treatment

Group B

PLACEBO COMPARATOR

Supervised aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing

Other: Physiotherapy Treatment

Interventions

Physiotherapy TreatmentOTHER

Pulmonary Rehabilitation Techniques

Group AGroup B

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 40 to 60
  • Gender: Both Males \& Females.
  • Diagnoses with an exacerbation of COPD.
  • Informed consent obtained.

You may not qualify if:

  • Inability to provide informed consent or complete a self-administered questionnaire.
  • Patients with trauma.
  • Females who were pregnant and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Rehabilitation

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Syed Alamdar Hussain, Phd

    Afridi Medical Complex

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 14, 2022

Study Start

February 23, 2022

Primary Completion

July 28, 2022

Study Completion

August 21, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)