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

NCT02698904 | Completed DMC

• 1 other identifier: FDG_COPDRELAX_01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Relaxation Technique; Anxiety

Outcome Measures

Primary Outcomes (1)

• Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)

  Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)

Secondary Outcomes (9)

• Changes in Heart Rate Variability (HRV), before, during and after the treatment

  It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)

• Changes in oxygen saturation (SpO2), before, during and after the treatment

  It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)

• Changes in airway resistance (kPa/l/s) before and after the treatment

  Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)

• Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1)

  Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)

• Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS)

  Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)

Study Arms (2)

Guided Relaxation Technique

EXPERIMENTAL

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.

Behavioral: Guided Relaxation Technique

Documentary movie

SHAM COMPARATOR

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.

Other: Documentary Movie

Interventions

Guided Relaxation Technique BEHAVIORAL

Also known as: Relaxation Therapy

Guided Relaxation Technique

Documentary Movie OTHER

Documentary movie

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy;
• psychiatric disturbances;
• oncological diseases;
• comorbid states that determine an immunosuppressive condition.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Paolo Banfi

Milan, 20148, Italy

Location

Related Publications (1)

• 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.

  PMID: 29744054 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 4, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 31, 2017

Record last verified: 2016-02

Locations

IT (1)