NCT05174741

Brief Summary

To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic obstructive pulmonary disease patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 21, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

June 21, 2021

Last Update Submit

February 20, 2023

Conditions

PneumoniaPulmonary FibrosisTuberculosisBronchiectasisAsthma

Keywords

non-COPDquality of lifepulmonary function

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

    3 weeks, 6 weeks

  • Forced vital Capacity (FVC)

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

    3 weeks,6 weeks

  • 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.

    3 weeks,6 weeks

Secondary Outcomes (1)

  • Health related Quality of life

    3 weeks,6 weeks

Study Arms (2)

Conventional Chest Physiotherapy

ACTIVE COMPARATOR

Diaphragmatic Breathing exercise 15 repetition ACBT \*3 sets/session\*TD Walk (10-15 minutes) \* BD

Other: Conventional Chest Physiotherapy

Aerobic Training group

EXPERIMENTAL

Supervised Conventional chest physiotherapy+ Aerobic training Conventional chest physiotherapy supervised (1st week) Then non supervised for 2nd to 6th week Warm-up (5 minutes) Breathing exercise and stepping Diaphragmatic Breathing exercise \*15 Reps\* TD Aerobic training on cycle ergometer: between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day Cool down (5 minutes) AROM +Body stretch

Other: Aerobic training Group

Interventions

Conventional Chest PhysiotherapyOTHER

Diaphragmatic Breathing exercise 15 repetition ACBT \*3 sets/session\*TD Walk (10-15 minutes) \* BD

Conventional Chest Physiotherapy
Aerobic training GroupOTHER

Supervised Conventional Chest Physiotherapy + Aerobic training Aerobic training on cycle ergometer: between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day

Aerobic Training group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed cases of non-COPD disease interstitial lung disease (pulmonary fibrosis), restrictive lung disease (TB, pneumonia), Bronchiectasis, and Asthma with FEV1 below 50%, FVC\<80%, and FEV1/FVC\>70%

You may not qualify if:

  • Clinically/vitally unstable or having Uncontrolled DM/HTN, Current smokers or ex-smokers of less than 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan railway hospital

Rawalpindi, Punjab Province, 43600, Pakistan

Location

MeSH Terms

Conditions

PneumoniaPulmonary FibrosisTuberculosisBronchiectasisAsthma

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesLung Diseases, InterstitialFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

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

June 21, 2021

First Posted

January 3, 2022

Study Start

April 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)