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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04009538
Other study ID # IzmirKCU1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date March 2019

Study information

Verified date July 2019
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.


Description:

Pulmonary rehabilitation (PR) program in patients with COPD reduces dyspnea perception, increases exercise capacity, improves quality of life, and reduces psychological symptoms. Unfortunately, these gains are not permanent, but disappear within 12-24 months. The aim of this study is to compare the gains of the second PR program with the first program.

Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Above 18 years

- Completed PR program

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rehabilitation program
exercise program twice a week

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Izmir Katip Celebi University

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise Capacity Six minutes walk test 6 minutes
Secondary Respiratory Functions Pulmonary Function Test 30 minutes
Secondary Dyspnea Sensation We used "Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. The score "1" represents the best level, where the score "5" indicates the poorest. 5 minutes
Secondary Disease Specific Quality of Life We used St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. 20 minutes
Secondary Anxiety and Depression Hospital Anxiety and Depression (HAD) Inventory was used for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively. 20 minutes
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