NCT03319108

Brief Summary

Our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

October 19, 2017

Last Update Submit

October 19, 2017

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Six minute walk test

    6 minute

Secondary Outcomes (4)

  • Respiratory Functions

    30 minutes

  • Dyspnea

    5 minutes

  • Disease Specific Quality of Life

    20 minutes

  • Health Related Quality of Life

    20 minutes

Study Arms (2)

Low Comorbidity Index Score

OTHER

CCI; 1-3 as Group 1

Other: Exercise

High Comorbidity Index Score

OTHER

CCI; 4 and above as Group 2

Other: Exercise

Interventions

ExerciseOTHER

Pulmonary Rehabilitation Program for 8 weeks

High Comorbidity Index ScoreLow Comorbidity Index Score

Sponsors & Collaborators

Related Publications (1)

  • Naz I, Sahin H, Varol Y, Komurcuoglu B. The effect of comorbidity severity on pulmonary rehabilitation outcomes in chronic obstructive pulmonary disease patients. Chron Respir Dis. 2019 Jan-Dec;16:1479972318809472. doi: 10.1177/1479972318809472.

    PMID: 30428708DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 24, 2017

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share