Healthy AgingNCT05350436
More Singing, Less Swinging - Is Singing Related to Improved Postural Control?
A study testing Balance Conditions and Singing in people with Healthy Aging and Balance; Distorted, run by Brunel University at 1 site in United Kingdom.
Trial summary
This study will investigate the extent to which singing affects balance and breathing. Singing therapy has potential as an adjunct or component of falls prevention programmes and in the treatment of breathing hypervigilance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Balance; Distorted, Singing
- What is being tested?
- Balance Conditions and Singing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2022to 10 Apr 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For young adults: 18 - 35 years of age
- For older adults: 60 years of age or older
- The "Older Adult" age group will be defined as adults aged 60 and older, based on the specifications of the World Health Organization (2017).
- The "Younger Adult" age group will be defined as adults aged 18 to 35 inclusive. There will be a buffer range of ages 36 to 59. This is being done to get a clear delineation between age groups.
Who cannot join
- For all:
- Any respiratory, neurological, cardiac disease or deficit (and are on regular medication for it), and/or mobility issues.
- Have tested positive for COVID-19 in the last 15 days (van Kampen et al., 2021)
- Are diagnosed with Chronic COVID Syndrome
- Conditions limiting the ability to stand for >1 minute independently (e.g., chronic fatigue, recent injury affecting balance)
- Pregnancy (although this will not apply to older adults)
- Conditions limiting participating in singing activities (aphasia, dysarthria, dysphonia, speech impairments)
- Investigating young adults allows to better isolate the effects of singing, as these individuals will not suffer from co-morbidities that may confound, modify or attenuate the effects. Conversely, the older adult group is relevant to study from a clinical point of view.
Trial locations and contacts
1 site in 1 country.
Elmar Kal, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Brunel University London Division of Physiotherapy
Uxbridge, UB8 3PH
Adam Lewis, PhD, +44(0)1895 266336, adam.lewis@brunel.ac.uk
Elmar Kal, PhD, elmar.kal@brunel.ac.uk
About this study
This study will investigate the extent to which singing affects balance and breathing.
Singing therapy has potential as an adjunct or component of falls prevention programmes and in the treatment of breathing hypervigilance. Reducing fall risk, and levels of hypervigilance and anxiety could have widespread benefits on participants participation and quality of life.
Investigators will aim to recruit both singers and non singers from older and younger adult age groups. Investigators will then be able to determine the balance response in untrained healthy young adults to understand the affects of singing training and aging on balance. The participants' balance will be measured via a force plate as they perform a series of speaking and singing tasks. Other outcomes will include breathing specific anxiety and attention to breathing, and balance specific anxiety and attention to balance.
Read the detailed description
Singing has become a popular arts-in-therapy activity used by physiotherapists as part of their clinical treatment. For example, Singing for Lung Health (SLH) programmes are used in the management of long-term respiratory conditions. These programmes involve group-based singing activities with a focus on breathing control and posture. There are indications that SLH is effective at alleviating symptoms of respiratory disease, likely due to a combination of physical, psychological and social mechanisms.
One main factor that could directly impact on breathing are affective and attentional changes. Reduced anxiety and depression through singing therapy has been suggested to improve breathing control and functioning in those with chronic respiratory conditions. Qualitative surveys have reported that participants find singing to be an "uplifting" activity and that singing with a group of peers may also help to combat isolation.
These changes may be accompanied by changes in allocation of attention. I.e., it is thought that anxiety leads to heightened vigilant monitoring of breathing, and that this hypervigilance leads to a switch in control of breathing from automatic to consciously processed, resulting in breathing dysfunction and breathlessness. Notably, normalisation of such excessive anxiety related vigilance may underpin the improvements that patients report after singing therapy, in terms of control of breathing and breathlessness during exacerbations. Singing therapy may therefore improve breathing control through reducing anxiety as well as associated attention to breathing. One aim of this study is to test this idea further, and to determine if singing impacts on breathing vigilance.
An additional potentially very important effect of singing interventions is that people may improve their balance control as well, both directly and indirectly. Breathing and postural control are tightly linked. We continuously need to make postural adjustment in response to disturbances due to (changes in) breathing - and especially so when breathing is effortful and accelerated. Several studies of SLH in patients with COPD report participants perceive singing had a positive impact on their posture. Also, recent studies suggest that expert singers have better postural control compared to novices. Better control over breathing thus may also improve postural control.
Indirectly, and similar to breathing vigilance, singing interventions may also help normalise individual's attention toward posture and balance. Fear of falling is common in people with respiratory conditions such as COPD. Typically, such fear / anxiety will lead to a strong, potentially excessive, increase in attention to balance. As with breathing, this "hypervigilance" can itself lead to distorted perception of unsteadiness. Singing therapy may therefore improve balance control through reducing anxiety and associated attention to movement.
Therefore, this study will also explore the effects of singing on balance control and associated changes in balance-related hypervigilance.
To investigate these questions, investigators planned a scoping study in which they:
- Aim to investigate the effects of singing on breathing control (e.g., breathing rate, breathing pattern assessment; see all outcomes below)
- Immediate: Effects of singing (varying demands) vs no-singing condition
- Long-term: differences between people with and without regular singing experience in terms of breathing control during no-singing vs singing conditions.
- Aim to investigate the effects of singing on breathing-related anxiety \& vigilance (state anxiety, breathing vigilance; self-reported)
- Immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
- Aim to investigate the effects of singing on balance control (sway, sway frequency)
- Immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
- Aim to investigate the effects of singing on balance-related anxiety and vigilance (state anxiety, balance hypervigilance, conscious processing of balance; all self-reported)
- Again, immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
- Conditions
- Healthy Aging, Balance; Distorted, Singing
- Being tested
- Balance Conditions, Singing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance ConditionsBehavioural
Balance Conditions: (~ 5 minutes in total)
- Balance Condition 1 (Feet 20cm apart)
- Balance Condition 2 (Feet together)
- Balance Condition 3 (Tandem stance)
Initial measurements of balance conditions serve two purposes: it generates a postural control baseline for us without the attribution of singing conditions, furthermore it allows us to separately measure long-term singing experience's effect on postural control, by assessing tasks differing in difficulty level. Balance conditions will be randomised to prevent a learning effect.
SingingBehavioural
Singing Conditions: (~ 15 minutes)
- Warmup - including jaw and breathing exercises
- Singing Condition 1 (Spoken Happy Birthday - Traditional Tempo)
- Singing Condition 2 (Sung Happy Birthday - Traditional Tempo
- Singing Condition 3 (Spoken Happy Birthday - Fast Tempo)
- Singing Condition 4 (Sung Happy Birthday - Fast Tempo)
- Singing Condition 5 (Spoken Happy Birthday - Slow Tempo)
- Singing Condition 6 (Sung Happy Birthday - Slow Tempo)
Link to singing instructional video:
https://www.dropbox.com/s/tro58i6vx6i6w3a/Singing%20Balance%20Exercise%20Video.mp4?dl=0
Time stamps for the video:
- Warmup (including jaw exercises and breathing exercises) - beginning at 2:55 until 6:06
- Happy Birthday protocol - beginning at 15:26 until 20:21
| Study group | Role | What they receive |
|---|---|---|
| Young adult non singers | Experimental | Not described Receives: Behavioral: Balance Conditions; Behavioral: Singing |
| Young adult singers | Experimental | Not described Receives: Behavioral: Balance Conditions; Behavioral: Singing |
| Older adult non singers | Experimental | Not described Receives: Behavioral: Balance Conditions; Behavioral: Singing |
| Older adult singers | Experimental | Not described Receives: Behavioral: Balance Conditions; Behavioral: Singing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Sway Amplitude
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each balance condition 1
Postural Sway Amplitude
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each balance condition 2
Postural Sway Amplitude
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each balance condition 3
Postural Sway Amplitude
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each singing condition 1-6
Secondary outcomes (28)
Sway frequency (in Hz)
sway frequency will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each balance condition 1
Sway frequency (in Hz)
sway frequency will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each balance condition 2
Sway frequency (in Hz)
sway frequency will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each balance condition 3
Sway frequency (in Hz)
sway frequency will be measured in both mediolateral and anterior-posterior directions
Measured: 30 seconds during each singing conditions 1-6
Balance-Vigilance Questionnaire
A balance vigilance questionnaire
Measured: Immediately after balance condition 1
Balance-Vigilance Questionnaire
A balance vigilance questionnaire
Measured: Immediately after balance condition 2
Breathe-Vigilance Questionnaire
A breathing vigilance questionnaire
Measured: Immediately after balance condition 3
Breathe-Vigilance Questionnaire
A breathing vigilance questionnaire
Measured: Immediately after each singing condition 1-6
blood oxygen saturation (SpO2)
oxygen saturation
Measured: Immediately after balance condition 1
blood oxygen saturation (SpO2)
oxygen saturation
Measured: Immediately after each singing condition 1-6
Heart rate
heart rate
Measured: immediately after balance condition 1
Heart rate
heart rate
Measured: Immediately after each singing condition 1-6
Respiratory rate
breaths per minute
Measured: Baseline measurement prior to all conditions for all participants
Respiratory rate
breaths per minute
Measured: Immediately after balance condition 1
Respiratory rate
breaths per minute
Measured: Immediately after each singing condition 1-6
Borg dyspnoea scale
participant completed measure of dyspnoea
Measured: Baseline assessment prior to all conditions for all participants
Borg dyspnoea scale
participant completed measure of dyspnoea
Measured: Immediately after balance condition 1
Borg dyspnoea scale
participant completed measure of dyspnoea
Measured: Immediately after balance condition 2
Borg dyspnoea scale
participant completed measure of dyspnoea
Measured: Immediately after balance condition 3
Borg dyspnoea scale
participant completed measure of dyspnoea
Measured: Immediately after each singing condition 1- 6
Breathing Pattern Assessment Tool
Researcher recorded observation of breathing pattern
Measured: Baseline measurement prior to conditions for all participants
Mental Readiness Form
Measure of state anxiety
Measured: Immediately after balance condition 1
Mental Readiness Form
Measure of state anxiety
Measured: Immediately after balance condition 2
Mental Readiness Form
Measure of state anxiety
Measured: Immediately after balance condition 3
Mental Readiness Form
Measure of state anxiety
Measured: Immediately after each singing condition 1-6
Timed Up and Go
Measure of physical performance
Measured: Before any of the singing and balance conditions (baseline measurement (older adults))
Fall Efficacy Scale International
Patient reported outcome measure of risk of falls
Measured: Before any of the singing and balance conditions a baseline measurement
State Trait Anxiety Inventory - Y2
Patient reported outcome measure of anxiety
Measured: Baseline measurement prior to any condition for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start25 Feb 2022
- Primary completion10 Apr 2023 (estimated)
- Study completion10 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brunel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Lewis, Brunel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350436
- Sponsor's protocol ID
- 35423
- Status last verified
- Sep 2022
- First submitted
- 30 Mar 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can request access to data on reasonable request via email to the study investigators.
Publications
Burdon JG, Juniper EF, Killian KJ, Hargreave FE, Campbell EJ. The perception of breathlessness in asthma. Am Rev Respir Dis. 1982 Nov;126(5):825-8. doi: 10.1164/arrd.1982.126.5.825.
PubMed 7149447Hodges PW, Gurfinkel VS, Brumagne S, Smith TC, Cordo PC. Coexistence of stability and mobility in postural control: evidence from postural compensation for respiration. Exp Brain Res. 2002 Jun;144(3):293-302. doi: 10.1007/s00221-002-1040-x. Epub 2002 Apr 13.
PubMed 12021811Lewis A, Cave P, Stern M, Welch L, Taylor K, Russell J, Doyle AM, Russell AM, McKee H, Clift S, Bott J, Hopkinson NS. Singing for Lung Health-a systematic review of the literature and consensus statement. NPJ Prim Care Respir Med. 2016 Dec 1;26:16080. doi: 10.1038/npjpcrm.2016.80.
PubMed 27906158Lord VM, Cave P, Hume VJ, Flude EJ, Evans A, Kelly JL, Polkey MI, Hopkinson NS. Singing teaching as a therapy for chronic respiratory disease--a randomised controlled trial and qualitative evaluation. BMC Pulm Med. 2010 Aug 3;10:41. doi: 10.1186/1471-2466-10-41.
PubMed 20682030Lord 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.
PubMed 23145504Oliveira CC, McGinley J, Lee AL, Irving LB, Denehy L. Fear of falling in people with chronic obstructive pulmonary disease. Respir Med. 2015 Apr;109(4):483-9. doi: 10.1016/j.rmed.2015.02.003. Epub 2015 Feb 14.
PubMed 25708268Peultier-Celli L, Audouin M, Beyaert C, Perrin P. Postural Control in Lyric Singers. J Voice. 2022 Jan;36(1):141.e11-141.e17. doi: 10.1016/j.jvoice.2020.04.019. Epub 2020 May 24.
PubMed 32456837Philip KE, Lewis A, Jeffery E, Buttery S, Cave P, Cristiano D, Lound A, Taylor K, Man WD, Fancourt D, Polkey MI, Hopkinson NS. Moving singing for lung health online in response to COVID-19: experience from a randomised controlled trial. BMJ Open Respir Res. 2020 Nov;7(1):e000737. doi: 10.1136/bmjresp-2020-000737.
PubMed 33239406Skingley, A. et al. 'Singing for Breathing': participants' perceptions of a group singing programme for people with COPD. Arts Health 6, 59-74 (2014).
van Kampen JJA, van de Vijver DAMC, Fraaij PLA, Haagmans BL, Lamers MM, Okba N, van den Akker JPC, Endeman H, Gommers DAMPJ, Cornelissen JJ, Hoek RAS, van der Eerden MM, Hesselink DA, Metselaar HJ, Verbon A, de Steenwinkel JEM, Aron GI, van Gorp ECM, van Boheemen S, Voermans JC, Boucher CAB, Molenkamp R, Koopmans MPG, Geurtsvankessel C, van der Eijk AA. Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19). Nat Commun. 2021 Jan 11;12(1):267. doi: 10.1038/s41467-020-20568-4.
PubMed 33431879Vidotto LS, Bigliassi M, Jones MO, Harvey A, Carvalho CRF. Stop Thinking! I Can't! Do Attentional Mechanisms Underlie Primary Dysfunctional Breathing? Front Physiol. 2018 Jun 22;9:782. doi: 10.3389/fphys.2018.00782. eCollection 2018. No abstract available.
PubMed 29988475Vidotto LS, Carvalho CRF, Harvey A, Jones M. Dysfunctional breathing: what do we know? J Bras Pneumol. 2019 Feb 11;45(1):e20170347. doi: 10.1590/1806-3713/e20170347.
PubMed 30758427World Health Organisation (WHO) (2017). Mental Health of Older Adult. Available at: https://www.who.int/news-room/fact-sheets/detail/mental-health-of-older-adults. Accessed 17/01/22)
World Health Organisation (WHO) (2021). Falls. Available at: https://www.who.int/news-room/fact-sheets/detail/falls (Accessed: 12/01/22)
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Singing, Less Swinging - Is Singing Related to Improved Postural Control?
- ClinicalTrials.gov ID
- NCT05350436
- Acronym / sponsor ID
- 35423
- Conditions
- Healthy Aging, Balance; Distorted, Singing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Brunel UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 10 Apr 2023 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 28 Apr 2022 (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.
This study will investigate the extent to which singing affects balance and breathing.
Singing therapy has potential as an adjunct or component of falls prevention programmes and in the treatment of breathing hypervigilance. Reducing fall risk, and levels of hypervigilance and anxiety could have widespread benefits on participants participation and quality of life.
Investigators will aim to recruit both singers and non singers from older and younger adult age groups. Investigators will then be able to determine the balance response in untrained healthy young adults to understand the affects of singing training and aging on balance. The participants' balance will be measured via a force plate as they perform a series of speaking and singing tasks. Other outcomes will include breathing specific anxiety and attention to breathing, and balance specific anxiety and attention to balance.
Detailed description
Singing has become a popular arts-in-therapy activity used by physiotherapists as part of their clinical treatment. For example, Singing for Lung Health (SLH) programmes are used in the management of long-term respiratory conditions. These programmes involve group-based singing activities with a focus on breathing control and posture. There are indications that SLH is effective at alleviating symptoms of respiratory disease, likely due to a combination of physical, psychological and social mechanisms.
One main factor that could directly impact on breathing are affective and attentional changes. Reduced anxiety and depression through singing therapy has been suggested to improve breathing control and functioning in those with chronic respiratory conditions. Qualitative surveys have reported that participants find singing to be an "uplifting" activity and that singing with a group of peers may also help to combat isolation.
These changes may be accompanied by changes in allocation of attention. I.e., it is thought that anxiety leads to heightened vigilant monitoring of breathing, and that this hypervigilance leads to a switch in control of breathing from automatic to consciously processed, resulting in breathing dysfunction and breathlessness. Notably, normalisation of such excessive anxiety related vigilance may underpin the improvements that patients report after singing therapy, in terms of control of breathing and breathlessness during exacerbations. Singing therapy may therefore improve breathing control through reducing anxiety as well as associated attention to breathing. One aim of this study is to test this idea further, and to determine if singing impacts on breathing vigilance.
An additional potentially very important effect of singing interventions is that people may improve their balance control as well, both directly and indirectly. Breathing and postural control are tightly linked. We continuously need to make postural adjustment in response to disturbances due to (changes in) breathing - and especially so when breathing is effortful and accelerated. Several studies of SLH in patients with COPD report participants perceive singing had a positive impact on their posture. Also, recent studies suggest that expert singers have better postural control compared to novices. Better control over breathing thus may also improve postural control.
Indirectly, and similar to breathing vigilance, singing interventions may also help normalise individual's attention toward posture and balance. Fear of falling is common in people with respiratory conditions such as COPD. Typically, such fear / anxiety will lead to a strong, potentially excessive, increase in attention to balance. As with breathing, this "hypervigilance" can itself lead to distorted perception of unsteadiness. Singing therapy may therefore improve balance control through reducing anxiety and associated attention to movement.
Therefore, this study will also explore the effects of singing on balance control and associated changes in balance-related hypervigilance.
To investigate these questions, investigators planned a scoping study in which they:
- Aim to investigate the effects of singing on breathing control (e.g., breathing rate, breathing pattern assessment; see all outcomes below)
- Immediate: Effects of singing (varying demands) vs no-singing condition
- Long-term: differences between people with and without regular singing experience in terms of breathing control during no-singing vs singing conditions.
- Aim to investigate the effects of singing on breathing-related anxiety \& vigilance (state anxiety, breathing vigilance; self-reported)
- Immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
- Aim to investigate the effects of singing on balance control (sway, sway frequency)
- Immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
- Aim to investigate the effects of singing on balance-related anxiety and vigilance (state anxiety, balance hypervigilance, conscious processing of balance; all self-reported)
- Again, immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young adult non singers | Experimental | Behavioral: Balance Conditions, Behavioral: Singing |
| Young adult singers | Experimental | Behavioral: Balance Conditions, Behavioral: Singing |
| Older adult non singers | Experimental | Behavioral: Balance Conditions, Behavioral: Singing |
| Older adult singers | Experimental | Behavioral: Balance Conditions, Behavioral: Singing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For young adults: 18 - 35 years of age
- For older adults: 60 years of age or older
- The "Older Adult" age group will be defined as adults aged 60 and older, based on the specifications of the World Health Organization (2017).
- The "Younger Adult" age group will be defined as adults aged 18 to 35 inclusive. There will be a buffer range of ages 36 to 59. This is being done to get a clear delineation between age groups.
Key exclusion criteria (8 listed)
- Any respiratory, neurological, cardiac disease or deficit (and are on regular medication for it), and/or mobility issues.
- Have tested positive for COVID-19 in the last 15 days (van Kampen et al., 2021)
- Are diagnosed with Chronic COVID Syndrome
- Conditions limiting the ability to stand for >1 minute independently (e.g., chronic fatigue, recent injury affecting balance)
- Pregnancy (although this will not apply to older adults)
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 |
|---|---|---|
| Balance ConditionsBalance Conditions: (~ 5 minutes in total) * Balance Condition 1 (Feet 20cm apart) * Balance Condition 2 (Feet together) * Balance Condition 3 (Tandem stance) Initial measurements of balance conditions serve two purposes: it generates a postural control baseline for us without the attribution of singing conditions, furthermore it allows us to separately measure long-term singing experience's effect on postural control, by assessing tasks differing in difficulty level. Balance conditions will be randomised to prevent a learning effect. | Behavioural | Older adult non singers, Older adult singers, Young adult non singers, Young adult singers |
| SingingSinging Conditions: (~ 15 minutes) * Warmup - including jaw and breathing exercises * Singing Condition 1 (Spoken Happy Birthday - Traditional Tempo) * Singing Condition 2 (Sung Happy Birthday - Traditional Tempo * Singing Condition 3 (Spoken Happy Birthday - Fast Tempo) * Singing Condition 4 (Sung Happy Birthday - Fast Tempo) * Singing Condition 5 (Spoken Happy Birthday - Slow Tempo) * Singing Condition 6 (Sung Happy Birthday - Slow Tempo) Link to singing instructional video: https://www.dropbox.com/s/tro58i6vx6i6w3a/Singing%20Balance%20Exercise%20Video.mp4?dl=0 Time stamps for the video: * Warmup (including jaw exercises and breathing exercises) - beginning at 2:55 until 6:06 * Happy Birthday protocol - beginning at 15:26 until 20:21 | Behavioural | Older adult non singers, Older adult singers, Young adult non singers, Young adult singers |
Primary outcome
Postural Sway Amplitude
Time frame: 30 seconds during each balance condition 1
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
Postural Sway Amplitude
Time frame: 30 seconds during each balance condition 2
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
Postural Sway Amplitude
Time frame: 30 seconds during each balance condition 3
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
Postural Sway Amplitude
Time frame: 30 seconds during each singing condition 1-6
An AMTI force plate (Optima AccuSway), will be used to measure postural sway this will be operationalised as "root-mean-square" sway signal throughout the trail (sample rate: 100Hz). Sway will be measured in both mediolateral and anterior-posterior directions
28 secondary outcomes
Sway frequency (in Hz)
Time frame: 30 seconds during each balance condition 1
Sway frequency (in Hz)
Time frame: 30 seconds during each balance condition 2
Sway frequency (in Hz)
Time frame: 30 seconds during each balance condition 3
Sway frequency (in Hz)
Time frame: 30 seconds during each singing conditions 1-6
Balance-Vigilance Questionnaire
Time frame: Immediately after balance condition 1
Balance-Vigilance Questionnaire
Time frame: Immediately after balance condition 2
Breathe-Vigilance Questionnaire
Time frame: Immediately after balance condition 3
Breathe-Vigilance Questionnaire
Time frame: Immediately after each singing condition 1-6
blood oxygen saturation (SpO2)
Time frame: Immediately after balance condition 1
blood oxygen saturation (SpO2)
Time frame: Immediately after each singing condition 1-6
Heart rate
Time frame: immediately after balance condition 1
Heart rate
Time frame: Immediately after each singing condition 1-6
Respiratory rate
Time frame: Baseline measurement prior to all conditions for all participants
Respiratory rate
Time frame: Immediately after balance condition 1
Respiratory rate
Time frame: Immediately after each singing condition 1-6
Borg dyspnoea scale
Time frame: Baseline assessment prior to all conditions for all participants
Borg dyspnoea scale
Time frame: Immediately after balance condition 1
Borg dyspnoea scale
Time frame: Immediately after balance condition 2
Borg dyspnoea scale
Time frame: Immediately after balance condition 3
Borg dyspnoea scale
Time frame: Immediately after each singing condition 1- 6
Breathing Pattern Assessment Tool
Time frame: Baseline measurement prior to conditions for all participants
Mental Readiness Form
Time frame: Immediately after balance condition 1
Mental Readiness Form
Time frame: Immediately after balance condition 2
Mental Readiness Form
Time frame: Immediately after balance condition 3
Mental Readiness Form
Time frame: Immediately after each singing condition 1-6
Timed Up and Go
Time frame: Before any of the singing and balance conditions (baseline measurement (older adults))
Fall Efficacy Scale International
Time frame: Before any of the singing and balance conditions a baseline measurement
State Trait Anxiety Inventory - Y2
Time frame: Baseline measurement prior to any condition for all participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 7149447Burdon JG, Juniper EF, Killian KJ, Hargreave FE, Campbell EJ. The perception of breathlessness in asthma. Am Rev Respir Dis. 1982 Nov;126(5):825-8. doi: 10.1164/arrd.1982.126.5.825.
- Background: PubMed 12021811Hodges PW, Gurfinkel VS, Brumagne S, Smith TC, Cordo PC. Coexistence of stability and mobility in postural control: evidence from postural compensation for respiration. Exp Brain Res. 2002 Jun;144(3):293-302. doi: 10.1007/s00221-002-1040-x. Epub 2002 Apr 13.
- Background: PubMed 27906158Lewis A, Cave P, Stern M, Welch L, Taylor K, Russell J, Doyle AM, Russell AM, McKee H, Clift S, Bott J, Hopkinson NS. Singing for Lung Health-a systematic review of the literature and consensus statement. NPJ Prim Care Respir Med. 2016 Dec 1;26:16080. doi: 10.1038/npjpcrm.2016.80.
- Background: PubMed 20682030Lord VM, Cave P, Hume VJ, Flude EJ, Evans A, Kelly JL, Polkey MI, Hopkinson NS. Singing teaching as a therapy for chronic respiratory disease--a randomised controlled trial and qualitative evaluation. BMC Pulm Med. 2010 Aug 3;10:41. doi: 10.1186/1471-2466-10-41.
- Background: PubMed 23145504Lord 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.
- Background: PubMed 25708268Oliveira CC, McGinley J, Lee AL, Irving LB, Denehy L. Fear of falling in people with chronic obstructive pulmonary disease. Respir Med. 2015 Apr;109(4):483-9. doi: 10.1016/j.rmed.2015.02.003. Epub 2015 Feb 14.
- Background: PubMed 32456837Peultier-Celli L, Audouin M, Beyaert C, Perrin P. Postural Control in Lyric Singers. J Voice. 2022 Jan;36(1):141.e11-141.e17. doi: 10.1016/j.jvoice.2020.04.019. Epub 2020 May 24.
- Background: PubMed 33239406Philip KE, Lewis A, Jeffery E, Buttery S, Cave P, Cristiano D, Lound A, Taylor K, Man WD, Fancourt D, Polkey MI, Hopkinson NS. Moving singing for lung health online in response to COVID-19: experience from a randomised controlled trial. BMJ Open Respir Res. 2020 Nov;7(1):e000737. doi: 10.1136/bmjresp-2020-000737.
- BackgroundSkingley, A. et al. 'Singing for Breathing': participants' perceptions of a group singing programme for people with COPD. Arts Health 6, 59-74 (2014).
- Background: PubMed 33431879van Kampen JJA, van de Vijver DAMC, Fraaij PLA, Haagmans BL, Lamers MM, Okba N, van den Akker JPC, Endeman H, Gommers DAMPJ, Cornelissen JJ, Hoek RAS, van der Eerden MM, Hesselink DA, Metselaar HJ, Verbon A, de Steenwinkel JEM, Aron GI, van Gorp ECM, van Boheemen S, Voermans JC, Boucher CAB, Molenkamp R, Koopmans MPG, Geurtsvankessel C, van der Eijk AA. Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19). Nat Commun. 2021 Jan 11;12(1):267. doi: 10.1038/s41467-020-20568-4.
- Background: PubMed 29988475Vidotto LS, Bigliassi M, Jones MO, Harvey A, Carvalho CRF. Stop Thinking! I Can't! Do Attentional Mechanisms Underlie Primary Dysfunctional Breathing? Front Physiol. 2018 Jun 22;9:782. doi: 10.3389/fphys.2018.00782. eCollection 2018. No abstract available.
- Background: PubMed 30758427Vidotto LS, Carvalho CRF, Harvey A, Jones M. Dysfunctional breathing: what do we know? J Bras Pneumol. 2019 Feb 11;45(1):e20170347. doi: 10.1590/1806-3713/e20170347.
- Individual participant dataSharing planned: No. Other researchers can request access to data on reasonable request via email to the study investigators.
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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.
Elmar Kal, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Conditions and Singing in people with Healthy Aging and Balance; Distorted, run by Brunel University at 1 site in United Kingdom.
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 8 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Lewis, PhD (+44(0)1895 266336, adam.lewis@brunel.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Sway Amplitude (time frame: 30 seconds during each balance condition 1). The study lists 4 primary outcomes in all. 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 NCT05350436, which also lists 14 linked publications.
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 19 Sep 2022.