Depression in Patients With Chronic Obstructive Pulmonary DiseaseEDICNCT02147912
Evaluation of Depression In Chronic Obstructive Pulmonary Disease
A study testing Aerobic Exercise in people with Depression in Patients With Chronic Obstructive Pulmonary Disease, run by University Hospital, Catania.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Depression in Patients With Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD and depression, eligibility to perform pulmonary rehabilitation according to ATS and ERS guidelines.
Who cannot join
- indication to restoring treatment of airway patency and current psychopharmacological treatment (including sleeping-pills).
Trial locations and contacts
No sites are listed yet.
About this study
Official 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.
Read more
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.
- Being tested
- Aerobic Exercise
- Keywords
- Depression, COPD, Aerobic Exercise, Anxiety, Quality of life, neurocognitive functioning
- Medical subject headings
- Depression, Pulmonary Disease, Chronic Obstructive, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Active comparator | A six week aerobic exercise intervention in COPD depressed population. Receives: Other: Aerobic Exercise |
| Control sample | No intervention | Only participants randomized in the arm named "Aerobic exercise" will receive a six weeks aerobic exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after intervention phase
Secondary outcomes (1)
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.
Measured: 6 weeks after intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Patients With Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Eugenio Aguglia, University Hospital, Catania
- Investigators
- Eugenio Aguglia, Prof., Principal investigator, UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, ItalyGiuseppe Minutolo, MD, PhD, Principal investigator, UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, ItalyGiuseppe Catalfo, MD, Principal investigator, UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, ItalyFrancesca Magnano S. Lio, MD, Principal investigator, UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, ItalyNunzio Crimi, Prof., Principal investigator, Pulmonary Rehabilitation Clinic - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147912
- Sponsor's protocol ID
- UHCatania
- Acronym
- EDIC
- Status last verified
- May 2014
- First submitted
- 22 May 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Depression In Chronic Obstructive Pulmonary Disease: a Longitudinal Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02147912
- Acronym / sponsor ID
- EDIC / UHCatania
- Keywords
- Depression, COPD, Aerobic Exercise, Anxiety, Quality of life, neurocognitive functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University Hospital, CataniaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Active comparator | Other: Aerobic ExerciseA six week aerobic exercise intervention in COPD depressed population. |
| Control sample | No intervention | –Only participants randomized in the arm named "Aerobic exercise" will receive a six weeks aerobic exercise intervention. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of COPD and depression, eligibility to perform pulmonary rehabilitation according to ATS and ERS guidelines.
Key exclusion criteria (1 listed)
- indication to restoring treatment of airway patency and current psychopharmacological treatment (including sleeping-pills).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAerobic 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. | Other | Aerobic exercise |
Primary outcome
variation of HDRS total score
Time frame: 6 weeks after intervention phase
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.
1 secondary outcome
daily functioning assessment
Time frame: 6 weeks after intervention phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenio Aguglia, Prof. 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 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 principal investigator
UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Depression in Patients With Chronic Obstructive Pulmonary Disease, run by University Hospital, Catania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Minutolo, MD, PhD (+39 0953782791, giuseppeminutolo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of HDRS total score (time frame: 6 weeks after intervention phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.