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Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT02698904

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-07-31

Brief Summary

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People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be exacerbated by psychological outcomes including anxiety and depression. Previous studies suggest that relaxation techniques may have positive effects on pulmonary rehabilitation. The main aim of this study is to explore both the respiratory and psychological impact of a quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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Chronic Obstructive Pulmonary Disease (COPD) Relaxation Technique Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Guided Relaxation Technique

Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes, one-session, guided relaxation technique Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes relaxation technique (listening via headphone to audio recording. In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording. Entire procedure 60-80 minutes.

Group Type EXPERIMENTAL

Guided Relaxation Technique

Intervention Type BEHAVIORAL

Documentary movie

Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes documentary movie.

Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes documentary movie (listening via headphone. In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording. Entire procedure 60-80 minutes.

Group Type SHAM_COMPARATOR

Documentary Movie

Intervention Type OTHER

Interventions

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Guided Relaxation Technique

Intervention Type BEHAVIORAL

Documentary Movie

Intervention Type OTHER

Other Intervention Names

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Relaxation Therapy

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent;
* Chronic Obstructive Pulmonary Disease (COPD) diagnosis confirmed by a specialized physician;
* basal FEV1/FVC \<70%, using the standards established by Global Initiative For Chronic Obstructive Lung Disease (GOLD);
* Modified British Medical Research Council Questionnaire (mMRC) ≥ 2;
* COPD Assessment Test (CAT) ≥ 10.

Exclusion Criteria

* Pregnancy;
* psychiatric disturbances;
* oncological diseases;
* comorbid states that determine an immunosuppressive condition.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Paolo Banfi

Milan, , Italy

Site Status

Countries

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Italy

References

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Volpato E, Banfi P, Nicolini A, Pagnini F. A quick relaxation exercise for people with chronic obstructive pulmonary disease: explorative randomized controlled trial. Multidiscip Respir Med. 2018 May 2;13:13. doi: 10.1186/s40248-018-0124-9. eCollection 2018.

Reference Type DERIVED
PMID: 29744054 (View on PubMed)

Other Identifiers

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FDG_COPDRELAX_01

Identifier Type: -

Identifier Source: org_study_id