Depression in Patients With Chronic Obstructive Pulmonary Disease Clinical Trial
— EDICOfficial title:
Evaluation of Depression In Chronic Obstructive Pulmonary Disease: a Longitudinal Randomized Controlled Trial.
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.
| Status | Not yet recruiting |
| Enrollment | 154 |
| Est. completion date | November 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 80 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Catania |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |