Evaluation of Depression In Chronic Obstructive Pulmonary Disease

NCT02147912 | Unknown DMC

• 1 other identifier: UHCatania
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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

Keywords

Depression; COPD; Aerobic Exercise; Anxiety; Quality of life; neurocognitive functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• daily functioning assessment

  6 weeks after intervention phase

Study Arms (2)

Aerobic exercise

ACTIVE COMPARATOR

A six week aerobic exercise intervention in COPD depressed population.

Other: Aerobic Exercise

Control sample

NO INTERVENTION

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

Interventions

Aerobic Exercise 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.

Aerobic exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD and depression, eligibility to perform pulmonary rehabilitation according to ATS and ERS guidelines.

You may not qualify if:

• indication to restoring treatment of airway patency and current psychopharmacological treatment (including sleeping-pills).

Sponsors & Collaborators

• University Hospital, Catania: lead

MeSH Terms

Conditions

Depression; Pulmonary Disease, Chronic Obstructive; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eugenio Aguglia, Prof.

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

  PRINCIPAL INVESTIGATOR

• Giuseppe Minutolo, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Giuseppe Catalfo, MD

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

  PRINCIPAL INVESTIGATOR

• Francesca Magnano S. Lio, MD

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

  PRINCIPAL INVESTIGATOR

• Nunzio Crimi, Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Minutolo, MD, PhD

CONTACT

+39 0953782791; giuseppeminutolo@hotmail.com

Francesca Magnano S. Lio, MD

CONTACT

+39 0953782470; francesca.magnanosanlio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Psychiatry

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 28, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 28, 2014

Record last verified: 2014-05