The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT03280355 | Completed DMC

• 1 other identifier: AU_Singing
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 11

Brief Summary

Patients with Chronic Obstructive Pulmonary Disease (COPD) experience physiological and psychological complications, such as shortness of breath, anxiety and depression. This has negative influence on their social life, daily activity level and overall quality of life. Patients can participate in a pulmonary rehabilitation program (PR) for the purpose of better managing of the disease and its symptoms and for avoiding future relapses and hospitalisations. However there is a large number of dropouts from PR, and therefore a need for investigation of new activities. Singing training may be one such potential relevant and motivating rehabilitation activity. This study aims to investigate the effects of singing training on both physiological and psychological aspects, and will compare the effects with that of physical training (golden standard in PR). Effects will be investigated in a randomised controlled trial (RCT) with 10 week intervention period. In all the study includes 11 municipalities from around all regions of Denmark, and in all 220 participants.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Randomised controlled trial (RCT); Rehabilitation; Singing Training

Outcome Measures

Primary Outcomes (1)

• 6 Minutes Walk Distance (6MWD)

  Meters

  12 weeks (+/- 2 weeks)

Secondary Outcomes (7)

• Pedometer

  12 weeks (+/- 2 weeks)

• St. George's Respiratory Questionnaire (SGRQ)

  12 weeks (+/- 2 weeks)

• Forced Expiratory Volume Predicted (FEV1%)

  12 weeks (+/- 2 weeks)

• Breath Hold Test

  12 weeks (+/- 2 weeks)

• Single-breath Count

  12 weeks (+/- 2 weeks)

Study Arms (2)

Singing Training

EXPERIMENTAL

Singing Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.

Behavioral: Singing training

Physical Training

ACTIVE COMPARATOR

Physical Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.

Behavioral: Physical Training

Interventions

Singing training BEHAVIORAL

Each session will contain technical instruction in order to achieve better respiratory control and primary muscular strength, and with focus on techniques for efficient expiration. Sessions will also focus on musical content and interpretation as well as interaction, the social aspects and joy of singing together. Prior to the trial all singing teachers will participate in a 2 days' workshop, where they will be instructed in sufficient methodology and didactics, and will obtain profound knowledge about the disease pathology and related physiology.

Singing Training

Physical Training BEHAVIORAL

Physical Training (golden standard training activity in pulmonary rehabilitation) - usual care - is the active comparator in the trial. The programme is based on the national guidelines for pulmonary rehabilitation, and consists of supervised warm-ups, aerobic exercises, workout (strength), and breathing exercises. Physical Training is conducted by the local physiotherapists in the local health centres.

Physical Training

Eligibility Criteria

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

You may qualify if:

• Participants with a clinical diagnosis of COPD and who meet the following criteria are eligible:
• Recommended for Pulmonary Rehabilitation and minimum mMRC2 level of dyspnea
• Motivated for participating in the project (and acceptance of randomization)
• Sufficient mobility to attend PR

You may not qualify if:

• Certain comorbidities (e.g. unstable coronary complications)
• Severe cognitive disabilities (e.g. dementia)
• Inability to speak or understand Danish
• No previous singing experience or musical competence is required.

Sponsors & Collaborators

• University of Aarhus: lead
• Region Zealand: collaborator

Study Sites (11)

Rudersdal Health Centre

Birkerød, 3460, Denmark

Location

Helsingor Health Centre

Elsinore, 3000, Denmark

Location

Fakse Health Centre

Fakse, 4640, Denmark

Location

Vesthimmerland Health Centre

Farsø, 9640, Denmark

Location

Hedensted Health Centre

Hedensted, 8722, Denmark

Location

Ikast-Brande Health Centre

Ikast, 7430, Denmark

Location

Lemvig Health Centre

Lemvig, 7620, Denmark

Location

Lolland Health Centre

Maribo, 4930, Denmark

Location

Silkeborg Health Centre

Silkeborg, 8600, Denmark

Location

Slagelse Health Centre

Slagelse, 4200, Denmark

Location

Vordingborg Health Centre

Vordingborg, 4760, Denmark

Location

Related Publications (2)

• Kaasgaard M, Rasmussen DB, Andreasson KH, Hilberg O, Lokke A, Vuust P, Bodtger U. Use of Singing for Lung Health as an alternative training modality within pulmonary rehabilitation for COPD: a randomised controlled trial. Eur Respir J. 2022 May 19;59(5):2101142. doi: 10.1183/13993003.01142-2021. Print 2022 May.

  PMID: 34625480 DERIVED

• Kaasgaard M, Andersen IC, Rasmussen DB, Hilberg O, Lokke A, Vuust P, Bodtger U. Heterogeneity in Danish lung choirs and their singing leaders: delivery, approach, and experiences: a survey-based study. BMJ Open. 2020 Nov 30;10(11):e041700. doi: 10.1136/bmjopen-2020-041700.

  PMID: 33257493 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Uffe Bodtger, MD PhD

  Region Zealand

  PRINCIPAL INVESTIGATOR

• Peter Vuust, Professor

  Aarhus Univeristy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessor (nurse) is masked, primary investigator is masked
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-pharmacological, intervention based, group randomised (cluster randomised) controlled trial, 2 arms (intervention and active control group)

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 12, 2017
• Study Start: August 1, 2017
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: June 22, 2023

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (11)