NCT02146235

Brief Summary

The investigators combine traditional medical care with an integrative modality - Music Therapy specifically including wind playing, singing, and music visualizations- to study the effects on physical function and quality of life for adults with COPD. The primary goals are to increase respiratory function and reduce respiratory symptoms and hospitalizations in order to improve breathing, functional capacity for activities of daily living, psychological well-being and quality of life in adult age 45 and above who are diagnosed with COPD

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

4.5 years

First QC Date

May 21, 2014

Last Update Submit

May 22, 2014

Conditions

Keywords

Music TherapyPulmonary DiseaseCOPDMusic VisualizationTherapeutic SingingWind-playingLung Condition

Outcome Measures

Primary Outcomes (3)

  • Chronic Respiratory Questionnaire Self-Reported (CRQ-SR)

    CRQ-SR is divided into four dimensions of dyspnea, fatigue, emotional function and mastery, with a 7-point Likert scale response for each question. Dyspnea relates to a patient's symptoms of shortness of breath and difficulty breathing. Mastery relates to a patient's sense of having control over his or her disease and symptoms. Emotion relates to a patient's general mood. Fatigue relates to a patient's energy level. Patients generally report that they feel better with an average improvement of 0.5 per dimension. Changes between 0.75 and 1.25 represent important changes of moderate magnitude, and changes greater than 1.5 represent important changes of large magnitude.

    up to six weeks

  • Beck Depression Inventory 2nd edition-Fast Screen (BDI-FS)

    BDI-FS), a 7-item subscale of the BDI-II. The BDI-FS measures signs and symptoms such as sadness, pessimism, past failure, anhedonia, self-dislike, self-criticalness, and suicidal thoughts or ideation. (P5:22). Each question on the BDI is answered on a scale of 0-3 (zero being little or none, and 3 representing a high level of the characteristic in question). Therefore the scale for the sum of the 7 questions goes from 0-21. The suggested scoring is 0-3 = minimal symptoms of depression, 4-6 = mild symptoms of depression, 7-9 = moderate symptoms of depression, and 10-21 = severe symptoms of depression.

    up to six weeks

  • Perceived dyspnea Visual Analogue Scale (VAS)

    A visual analogue scale, consisted in a succession of lung draws representing the breathlessness process with a numerical rating scale. This unidimensional instrument is commonly used in the measurement of dyspnea.

    Treatment group only. It is administrated prior and post every music therapy session. (6 weeks)

Study Arms (2)

Treatment Group - Music Therapy

EXPERIMENTAL

The experimental group participates in once weekly group music therapy session for 6 weeks using playing of simple wind instruments, singing, and music visualization. The Music therapy session lasts 45 min. and encourages patients to use breathing techniques to achieve a relaxation response. Extructured techniques involving singing, music improvisation supports breath pattens and provides supporting coping styles. The use of wind instruments involves a focus of breathing efficiently and elongating the exhalation to prolong musical tones and transferring breath control. Music Visualization involving deep breathing techniques provides optimal mind-body connection, influences breathing rhythms through more indirect means while reducing stress, accessing altered states and encourages healing imagery.

Behavioral: Psycho-Music Therapy

Standard Pulmonary Rehabilitation

NO INTERVENTION

Pulmonary rehabilitation is a program to people with chronic lung diseases like COPD, emphysema, and chronic bronchitis lead full, satisfying lives and restore them to their highest functional capacity. Pulmonary rehab is aimed to improve quality of life by: Decreasing respiratory symptoms and complications Encouraging self-management and control over daily functioning Improving physical conditioning and exercise performance Improving emotional well-being Reducing hospitalizations Pulmonary rehab programs include: Medical management Exercise Breathing retraining Education Emotional support Nutrition counseling

Interventions

Treatment Group - Music Therapy

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients were required to be medically stable simultaneously allowing them to participate in the pulmonary rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Related Publications (22)

  • Bauldoff GS, Rittinger M, Nelson T, Doehrel J, Diaz PT. Feasibility of distractive auditory stimuli on upper extremity training in persons with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2005 Jan-Feb;25(1):50-5. doi: 10.1097/00008483-200501000-00011.

    PMID: 15714113BACKGROUND
  • Panigrahi A, Sohani S, Amadi C, Joshi A. Role of music in the management of chronic obstructive pulmonary disease (COPD): a literature review. Technol Health Care. 2014;22(1):53-61. doi: 10.3233/THC-130773.

    PMID: 24398814BACKGROUND
  • Bauldoff GS, Hoffman LA, Zullo TG, Sciurba FC. Exercise maintenance following pulmonary rehabilitation: effect of distractive stimuli. Chest. 2002 Sep;122(3):948-54. doi: 10.1378/chest.122.3.948.

    PMID: 12226037BACKGROUND
  • von Leupoldt A, Taube K, Schubert-Heukeshoven S, Magnussen H, Dahme B. Distractive auditory stimuli reduce the unpleasantness of dyspnea during exercise in patients with COPD. Chest. 2007 Nov;132(5):1506-12. doi: 10.1378/chest.07-1245. Epub 2007 Sep 21.

    PMID: 17890458BACKGROUND
  • Pfister T, Berrol C, Caplan C. Effects of music on exercise and perceived symptoms in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 1998 May-Jun;18(3):228-32. doi: 10.1097/00008483-199805000-00007.

    PMID: 9632325BACKGROUND
  • Thornby MA, Haas F, Axen K. Effect of distractive auditory stimuli on exercise tolerance in patients with COPD. Chest. 1995 May;107(5):1213-7. doi: 10.1378/chest.107.5.1213.

    PMID: 7750308BACKGROUND
  • Ho CF, Maa SH, Shyu YI, Lai YT, Hung TC, Chen HC. Effectiveness of paced walking to music at home for patients with COPD. COPD. 2012 Aug;9(5):447-57. doi: 10.3109/15412555.2012.685664. Epub 2012 May 29.

    PMID: 22643033BACKGROUND
  • Louie SW. The effects of guided imagery relaxation in people with COPD. Occup Ther Int. 2004;11(3):145-59. doi: 10.1002/oti.203.

    PMID: 15297895BACKGROUND
  • Singh VP, Rao V, V P, R C S, K KP. Comparison of the effectiveness of music and progressive muscle relaxation for anxiety in COPD--A randomized controlled pilot study. Chron Respir Dis. 2009;6(4):209-16. doi: 10.1177/1479972309346754.

    PMID: 19858350BACKGROUND
  • le Roux FH, Bouic PJ, Bester MM. The effect of Bach's magnificat on emotions, immune, and endocrine parameters during physiotherapy treatment of patients with infectious lung conditions. J Music Ther. 2007 Summer;44(2):156-68. doi: 10.1093/jmt/44.2.156.

    PMID: 17484523BACKGROUND
  • Sliwka A, Nowobilski R, Polczyk R, Nizankowska-Mogilnicka E, Szczeklik A. Mild asthmatics benefit from music therapy. J Asthma. 2012 May;49(4):401-8. doi: 10.3109/02770903.2012.663031. Epub 2012 Mar 7.

    PMID: 22397390BACKGROUND
  • Muller V, Lindenberger U. Cardiac and respiratory patterns synchronize between persons during choir singing. PLoS One. 2011;6(9):e24893. doi: 10.1371/journal.pone.0024893. Epub 2011 Sep 21.

    PMID: 21957466BACKGROUND
  • Irons JY, Kenny DT, Chang AB. Singing for children and adults with bronchiectasis. Cochrane Database Syst Rev. 2010 Feb 17;2010(2):CD007729. doi: 10.1002/14651858.CD007729.pub2.

    PMID: 20166097BACKGROUND
  • Herer B. [Outcomes of a pulmonary rehabilitation program including singing training]. Rev Mal Respir. 2013 Mar;30(3):194-202. doi: 10.1016/j.rmr.2012.10.602. Epub 2012 Dec 13. French.

    PMID: 23497929BACKGROUND
  • Lord VM, Hume VJ, Kelly JL, Cave P, Silver J, Waldman M, White C, Smith C, Tanner R, Sanchez M, Man WD, Polkey MI, Hopkinson NS. Singing classes for chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2012 Nov 13;12:69. doi: 10.1186/1471-2466-12-69.

    PMID: 23145504BACKGROUND
  • Bonilha AG, Onofre F, Vieira ML, Prado MY, Martinez JA. Effects of singing classes on pulmonary function and quality of life of COPD patients. Int J Chron Obstruct Pulmon Dis. 2009;4:1-8. Epub 2009 Apr 15.

    PMID: 19436683BACKGROUND
  • Goodridge D, Nicol JJ, Horvey KJ, Butcher S. Therapeutic Singing as an Adjunct for Pulmonary Rehabilitation Participants With COPD Outcomes of a Feasibility Study. Music and Medicine 2013; 5(3): 169-176.

    BACKGROUND
  • BOUHUYS A. LUNG VOLUMES AND BREATHING PATTERNS IN WIND-INSTRUMENT PLAYERS. J Appl Physiol. 1964 Sep;19:967-75. doi: 10.1152/jappl.1964.19.5.967. No abstract available.

    PMID: 14207753BACKGROUND
  • Bouhuys A (1968) Pressure-flow events during wind instrument playing. Ann New York Acad Sci 155(1):264-275

    BACKGROUND
  • Zuskin E, Mustajbegovic J, Schachter EN, Kern J, Vitale K, Pucarin-Cvetkovic J, Chiarelli A, Milosevic M, Jelinic JD. Respiratory function in wind instrument players. Med Lav. 2009 Mar-Apr;100(2):133-41.

    PMID: 19382523BACKGROUND
  • Alexander JL, Wagner CL. Is harmonica playing an effective adjunct therapy to pulmonary rehabilitation? Rehabil Nurs. 2012 Jul-Aug;37(4):207-12. doi: 10.1002/rnj.33. Epub 2012 Jun 18.

    PMID: 22744994BACKGROUND
  • Bausewein C, Booth S, Gysels M, Higginson IJ. WITHDRAWN: Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database Syst Rev. 2013 Nov 22;2013(11):CD005623. doi: 10.1002/14651858.CD005623.pub3.

    PMID: 24272974BACKGROUND

MeSH Terms

Conditions

Lung DiseasesPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

June 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations