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

• ClinicalTrials.gov Identifier: NCT02698904
• Recruitment Status: Completed
• First Posted: March 4, 2016
• Last Update Posted: July 31, 2017
• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborator: Catholic University of the Sacred Heart
• Information provided by (Responsible Party): Fondazione Don Carlo Gnocchi Onlus

Tracking Information

• First Submitted Date: February 23, 2016
• First Posted Date: March 4, 2016
• Last Update Posted Date: July 31, 2017
• Study Start Date: January 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 29, 2016): Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG) [ Time Frame: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 29, 2016)

• Changes in Heart Rate Variability (HRV), before, during and after the treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time) ]
• Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS) [ Time Frame: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time) ]
• Presence and intensity of the possible subjective experience of engaging just-manageable challenges by tackling a series of goals, continuously processing feedback about progress, and adjusting action based on this feedback, after the treatment [ Time Frame: After the session of relaxation training/documentary movie (60-80 minutes after the baseline) ]
  Presence and intensity of the possible state of flow experience, as assessed by a short form of the Flow State Scale, called Short Flow State Scale -2 (FSS-2)
• Differences in Forced Vital Capacity (FVC), before and after the treatment [ Time Frame: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time) ]
• Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment [ Time Frame: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
• Official Title: A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease (COPD)

Intervention

• Behavioral: Guided Relaxation Technique
  Other Name: Relaxation Therapy
• Other: Documentary Movie

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Guided Relaxation Technique
• Sham Comparator: 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.

  Intervention: Other: Documentary Movie

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2017): 39
• Original Estimated Enrollment (submitted: February 29, 2016): 30
• Actual Study Completion Date: July 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02698904
• Other Study ID Numbers: FDG_COPDRELAX_01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Fondazione Don Carlo Gnocchi Onlus
• Study Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Catholic University of the Sacred Heart
• Investigators: Not Provided
• PRS Account: Fondazione Don Carlo Gnocchi Onlus
• Verification Date: February 2016