Evaluation of Depression In Chronic Obstructive Pulmonary Disease

NCT ID: NCT02147912

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Depression in Patients With Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic exercise

A six week aerobic exercise intervention in COPD depressed population.

Group Type: ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type: OTHER

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.

Control sample

Only participants randomized in the arm named "Aerobic exercise" will receive a six weeks aerobic exercise intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic Exercise

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Catania

OTHER

Sponsor Role: lead

Responsible Party

Prof. Eugenio Aguglia

Full Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugenio Aguglia, Prof.

Role: PRINCIPAL_INVESTIGATOR

UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy

Giuseppe Minutolo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy

Giuseppe Catalfo, MD

Role: PRINCIPAL_INVESTIGATOR

UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy

Francesca Magnano S. Lio, MD

Role: PRINCIPAL_INVESTIGATOR

UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy

Nunzio Crimi, Prof.

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Rehabilitation Clinic - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy

Central Contacts

Giuseppe Minutolo, MD, PhD

Role: CONTACT

giuseppeminutolo@hotmail.com

+39 0953782791

Francesca Magnano S. Lio, MD

Role: CONTACT

francesca.magnanosanlio@gmail.com

+39 0953782470

Other Identifiers

UHCatania

Identifier Type: -

Identifier Source: org_study_id