Evaluation of Depression In Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Background: Several clinical studies show high rates of anxiety and depressive disorders in Chronic Obstructive Pulmonary Disease (COPD), that suggest common underlying pathogenetic mechanisms of COPD and depressive disorders. The aim of this study is to evaluate the effects of aerobic exercise, proposed in the context of pulmonary rehabilitation, in a sample of COPD depressed patients without psychopharmacological treatment, through the correlation of some psychopathological variables and physical/pneumological parameters. Methods: The investigators have designed an observational longitudinal trial. The trial will be prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on depressive symptoms in 154 patient affected by COPD and depression, assessed by Hamilton Depression Rating Scale (HDRS). The investigators will also monitor anxiety, quality of life and neurocognitive function. Outcome measures: The investigators compare the variation of HDRS total score, as primary outcome measure, in two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status; age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic exercise intervention. Statistical analysis: All tests are two-tailed and a p value 0.05 was considered significant. The difference between the two groups will be evaluated with Student's T test for normally distributed data, and with Mann-Whitney's U test, for those with not normal distribution. The normality of distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations among the variables under evaluation will be assessed by Spearman r correlation. Variables will be compared using the Chi-squared test or Fisher exact test for categorical variables. Discussion: There is a strong correlation between physical activity and mental health. Several data have suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and to psychotherapy, on reducing depressive symptomatology. The goal of our study is to propose an effective intervention to reduce the risk of severe depression in this special population, evaluating the variation of HDRS total score after the aerobic exercise intervention.

Official Title
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Evaluation of Depression In Chronic Obstructive Pulmonary Disease: a Longitudinal Randomized Controlled Trial.

Conditions
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Depression in Patients With Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD and depression, eligibility to perform pulmonary rehabilitation according to ATS and ERS guidelines. Exclusion Criteria: indication to restoring treatment of airway patency and current psychopharmacological treatment (including sleeping-pills).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic exercise<br>A six week aerobic exercise intervention in COPD depressed population. | Other: Aerobic Exercise<br>* Aerobic exercise intervention consists of lower (treadmill and cyclette) and upper arts (arm ergometer Davenbike®) training, as well as calisthenic exercises with increasing intensity from a minimum of 80% to a maximum workload for lower arts in a minimum time.<br>|
| No Intervention: Control sample<br>Only participants randomized in the arm named Aerobic exercise will receive a six weeks aerobic exercise intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of HDRS total score | we compare the variation of HDRS total score, as primary outcome measure, in two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status; age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic exercise intervention. | 6 weeks after intervention phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily functioning assessment | Evaluation of potential benefits on: anxiety symptoms, cognitive features, daily physical function (related to physical performances and/or to psychopathological dimensions) and quality of life. | 6 weeks after intervention phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Depression, COPD, Aerobic Exercise, Quality of life, neurocognitive functioning