COPDNCT01833260
Music and Perceived Rate of Exertion
A study testing Music in people with COPD, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aim of this study was to evaluate the effect of listening to ambient music on the perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary disease patients. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- May 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participate in the program for at least one month after the initial medical investigation, be free of exacerbations for 1 month and have maintained exactly the same program session for both evaluated sessions
Who cannot join
- participate to only session of one condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Distractive Auditory Stimulus on the Rate of Exertion During Pulmonary Rehabilitation Sessions
The aim of this study was to evaluate the effect of listening to ambient music on the perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary disease patients.
- Conditions
- COPD
- Being tested
- Music
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
| Study group | Role | What they receive |
|---|---|---|
| With music | Experimental | Pulmonary rehabilitation with music in the room Receives: Behavioral: Music |
| Without music | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of exertion
Measured: After 1 hour
Secondary outcomes (2)
Dyspnea
Using a visual analogue scale
Measured: After 1 hour
Hospital Anxiety Depression Scale
The score of anxiety and depression will be measured
Measured: After 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833260
- Sponsor's protocol ID
- Music
- Status last verified
- Jul 2014
- First submitted
- 10 Apr 2013
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Reychler G, Mottart F, Boland M, Wasterlain E, Pieters T, Caty G, Liistro G. Influence of ambient music on perceived exertion during a pulmonary rehabilitation session: a randomized crossover study. Respir Care. 2015 May;60(5):711-7. doi: 10.4187/respcare.03671. Epub 2015 Jan 13.
PubMed 25587172
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Distractive Auditory Stimulus on the Rate of Exertion During Pulmonary Rehabilitation Sessions
- ClinicalTrials.gov ID
- NCT01833260
- Acronym / sponsor ID
- Music
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the effect of listening to ambient music on the perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary disease patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With music | Experimental | Behavioral: MusicPulmonary rehabilitation with music in the room |
| Without music | No intervention | – |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participate in the program for at least one month after the initial medical investigation, be free of exacerbations for 1 month and have maintained exactly the same program session for both evaluated sessions
Key exclusion criteria (1 listed)
- participate to only session of one condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music | Behavioural | With music |
Primary outcome
Rate of exertion
Time frame: After 1 hour
2 secondary outcomes
Dyspnea
Time frame: After 1 hour
Hospital Anxiety Depression Scale
Time frame: After 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Derived from this study: PubMed 25587172Reychler G, Mottart F, Boland M, Wasterlain E, Pieters T, Caty G, Liistro G. Influence of ambient music on perceived exertion during a pulmonary rehabilitation session: a randomized crossover study. Respir Care. 2015 May;60(5):711-7. doi: 10.4187/respcare.03671. Epub 2015 Jan 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with COPD, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of exertion (time frame: After 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01833260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.