Clinical trial NCT02147912: Evaluation of Depression In Chronic Obstructive Pulmonary Disease
Official title: Evaluation of Depression In Chronic Obstructive Pulmonary Disease: a Longitudinal Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression in Patients With Chronic Obstructive Pulmonary Disease
Keywords: Depression
COPD
Aerobic Exercise
Anxiety
Quality of life
neurocognitive functioning
Lead sponsor: University Hospital, Catania
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 154
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: variation of HDRS total score
timeFrame: 6 weeks after intervention phase
Secondary outcomes:
measure: daily functioning assessment
timeFrame: 6 weeks after intervention phase
Other outcomes:
Locations:
Study officials:
affiliation: UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy
name: Eugenio Aguglia, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy
name: Giuseppe Minutolo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy
name: Giuseppe Catalfo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy
name: Francesca Magnano S. Lio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary Rehabilitation Clinic - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy
name: Nunzio Crimi, Prof.
role: PRINCIPAL_INVESTIGATOR
References: