NCT03671187

Brief Summary

Pulmonary rehabilitation (PR) is known to reduce dyspnea, increase exercise capacity, reduce psychological symptoms and improve quality of life in COPD patients. Some patients continue to smoke despite their illness. Smoking does not create a contraindication to PR. There is insufficient evidence on the effectiveness of PR programs in smoking COPD patients. The purpose of this study, PR completed the program to determine the effectiveness of PR smoker COPD patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

3.6 years

First QC Date

September 12, 2018

Last Update Submit

September 13, 2018

Conditions

SmokingRehabilitation; Tobacco Use

Outcome Measures

Primary Outcomes (1)

  • Six minute walk test

    It was performed in a 30-meter long corridor in accordance with American Thoracic

    6 minutes

Secondary Outcomes (5)

  • Pulmonary Function Test

    20 minutes

  • Dyspnea Severity

    5 minues

  • St. George Disease Related Quality of Life Scale

    20 minutes

  • Short Form-36 Quality of Life Survey

    25 minutes

  • Hospital Anxiety and Depression Inventory

    20 minutes

Study Arms (2)

Smoking

EXPERIMENTAL

8 week exercise program consists of breathing exercises, strength training and endurance training

Other: Exercise

Ex- Smoking

EXPERIMENTAL

8 week exercise program consists of breathing exercises, strength training and endurance training

Other: Exercise

Interventions

ExerciseOTHER

8 week exercise program

Ex- SmokingSmoking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients completed 8 PR program

You may not qualify if:

  • Never smoked patients
  • Participated PR program in last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SmokingTobacco Use

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

January 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 17, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share