Long CovidssNCT04810065
SingStrong: Strong Lungs Through Song - Long COVID-19 Study
A study testing SingStrong: Strong lungs through Song in people with Long Covid, run by University of Limerick at 1 site in Ireland.
Trial summary
Evidence is emerging that many individuals who recover from Covid-19 are experiencing a range of residual problems. These include fatigue, pain, reduced exercise tolerance and breathing issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid
- What is being tested?
- SingStrong: Strong lungs through Song
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 29 Mar 2021to 1 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Previous clinical diagnosis of Covid-19
- Ongoing issues with any or all of: Shortness of breath, disordered breathing, reduced exercise tolerance
- Good written and spoken English language
Who cannot join
- Lack of a confirmed Covid-19 diagnosis
- Currently undergoing a similar singing or breathing retraining intervention
- No residual problems from a confirmed case of Covid-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SingStrong: Strong Lungs Through Song
Evidence is emerging that many individuals who recover from Covid-19 are experiencing a range of residual problems. These include fatigue, pain, reduced exercise tolerance and breathing issues. This study includes participants who are experiencing problems with their lungs such as breathing difficulties, shortness of breath, and/or reduced exercise tolerance. The intervention is a twice weekly singing and breathing retraining intervention conducted over ten weeks. A range of self-report questionnaire measures will evaluate the efficacy of the intervention in addressing these problems. Focus groups and individual interviews will also be used to gather information on the impact and acceptability of the programme.
- Conditions
- Long Covid
- Being tested
- SingStrong: Strong lungs through Song
- Keywords
- Singing, Disordered breathing, Covid-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SingStrong: Strong lungs through SongOther
Participants who have been clinically diagnosed with Covid-19 and who continue to suffer residual adverse effects on the lung health will be invited to participate in the study.
The intervention will involve biweekly hour-long breathing and singing classes that are designed to correct dis-ordered breathing, and retrain the principal muscles of respiration.
Pre and post evaluation of participant bio-psychosocial health and wellness will be conducted. Triangulation of data using focus groups and individual interviews will be conducted after conclusion of the intervention,
| Study group | Role | What they receive |
|---|---|---|
| SingStrong for Pulmonary Fibrosis | Other | This arm of the project explores Singing as an intervention for people suffering from Pulmonary Fibrosis specifically.
It is a 10 week programme. All other aspects of the intervention are the same in terms of delivery and length of classes.
Different outcome measures, namely the St Georges Respiratory Questionnaire is used in this trial. This is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. Receives: Other: SingStrong: Strong lungs through Song |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 Yorkshire Rehab Screen (C19YRS)
The C19YRS was developed as a screening tool to monitor long-term symptoms due to Covid-19. The screening tool covers 19 items which combines yes/no answers and an 11 point ordinal scale (0-10) where a higher score denotes increased symptom severity.
Measured: 12 weeks
Secondary outcomes (1)
DePaul Symptom Questionnaire - Short Form DSQ - SF
The DPSQ -SF assesses key symptoms of ME/Chronic Fatigue Syndrome such as fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. A higher score denotes increased symptom severity.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start29 Mar 2021
- Primary completion29 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long CovidStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roisin Cahalan, University of Limerick
- Investigators
- Roisin Cahalan, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810065
- Sponsor's protocol ID
- SingStrong
- Acronym
- ss
- Status last verified
- Sep 2021
- First submitted
- 19 Mar 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SingStrong: Strong Lungs Through Song
- ClinicalTrials.gov ID
- NCT04810065
- Acronym / sponsor ID
- ss / SingStrong
- Conditions
- Long Covid
- Keywords
- Singing, Disordered breathing, Covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- 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.
Evidence is emerging that many individuals who recover from Covid-19 are experiencing a range of residual problems. These include fatigue, pain, reduced exercise tolerance and breathing issues. This study includes participants who are experiencing problems with their lungs such as breathing difficulties, shortness of breath, and/or reduced exercise tolerance. The intervention is a twice weekly singing and breathing retraining intervention conducted over ten weeks. A range of self-report questionnaire measures will evaluate the efficacy of the intervention in addressing these problems. Focus groups and individual interviews will also be used to gather information on the impact and acceptability of the programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SingStrong for Pulmonary Fibrosis | Other | Other: SingStrong: Strong lungs through SongThis arm of the project explores Singing as an intervention for people suffering from Pulmonary Fibrosis specifically. It is a 10 week programme. All other aspects of the intervention are the same in terms of delivery and length of classes. Different outcome measures, namely the St Georges Respiratory Questionnaire is used in this trial. This is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Previous clinical diagnosis of Covid-19
- Ongoing issues with any or all of: Shortness of breath, disordered breathing, reduced exercise tolerance
- Good written and spoken English language
Key exclusion criteria (3 listed)
- Lack of a confirmed Covid-19 diagnosis
- Currently undergoing a similar singing or breathing retraining intervention
- No residual problems from a confirmed case of Covid-19
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 |
|---|---|---|
| SingStrong: Strong lungs through SongParticipants who have been clinically diagnosed with Covid-19 and who continue to suffer residual adverse effects on the lung health will be invited to participate in the study. The intervention will involve biweekly hour-long breathing and singing classes that are designed to correct dis-ordered breathing, and retrain the principal muscles of respiration. Pre and post evaluation of participant bio-psychosocial health and wellness will be conducted. Triangulation of data using focus groups and individual interviews will be conducted after conclusion of the intervention, | Other | SingStrong for Pulmonary Fibrosis |
Primary outcome
Covid-19 Yorkshire Rehab Screen (C19YRS)
Time frame: 12 weeks
The C19YRS was developed as a screening tool to monitor long-term symptoms due to Covid-19. The screening tool covers 19 items which combines yes/no answers and an 11 point ordinal scale (0-10) where a higher score denotes increased symptom severity.
1 secondary outcome
DePaul Symptom Questionnaire - Short Form DSQ - SF
Time frame: 12 weeks
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 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Roisin Cahalan, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SingStrong: Strong lungs through Song in people with Long Covid, run by University of Limerick at 1 site in Ireland.
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 4 inclusion and 3 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 28 Sep 2021. 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 Ireland. 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?
Covid-19 Yorkshire Rehab Screen (C19YRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.