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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05350436
Other study ID # 35423
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2022
Est. completion date April 10, 2023

Study information

Verified date September 2022
Source Brunel University
Contact Adam Lewis, PhD
Phone +44(0)1895 266336
Email adam.lewis@brunel.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date April 10, 2023
Est. primary completion date April 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Balance Conditions
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.
Singing
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

Locations

Country Name City State
United Kingdom Brunel University London Division of Physiotherapy Uxbridge

Sponsors (1)

Lead Sponsor Collaborator
Brunel University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

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. — View Citation

Hodges 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. Epub 2002 Apr 13. — View Citation

Lewis 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. Review. — View Citation

Lord 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. — View Citation

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. Erratum in: BMC Pulm Med. 2014;14:181. — View Citation

Oliveira 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. — View Citation

Peultier-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. Review. — View Citation

Philip 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). pii: e000737. doi: 10.1136/bmjresp-2020-000737. — View Citation

Skingley, 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. — View Citation

Vidotto 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. — View Citation

Vidotto 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. Review. English, Portuguese. — View Citation

World 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)

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 30 seconds during each balance condition 1
Primary 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 30 seconds during each balance condition 2
Primary 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 30 seconds during each balance condition 3
Primary 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 30 seconds during each singing condition 1-6
Secondary Sway frequency (in Hz) sway frequency will be measured in both mediolateral and anterior-posterior directions 30 seconds during each balance condition 1
Secondary Sway frequency (in Hz) sway frequency will be measured in both mediolateral and anterior-posterior directions 30 seconds during each balance condition 2
Secondary Sway frequency (in Hz) sway frequency will be measured in both mediolateral and anterior-posterior directions 30 seconds during each balance condition 3
Secondary Sway frequency (in Hz) sway frequency will be measured in both mediolateral and anterior-posterior directions 30 seconds during each singing conditions 1-6
Secondary Balance-Vigilance Questionnaire A balance vigilance questionnaire Immediately after balance condition 1
Secondary Balance-Vigilance Questionnaire A balance vigilance questionnaire Immediately after balance condition 2
Secondary Breathe-Vigilance Questionnaire A breathing vigilance questionnaire Immediately after balance condition 3
Secondary Breathe-Vigilance Questionnaire A breathing vigilance questionnaire Immediately after each singing condition 1-6
Secondary blood oxygen saturation (SpO2) oxygen saturation Immediately after balance condition 1
Secondary blood oxygen saturation (SpO2) oxygen saturation Immediately after each singing condition 1-6
Secondary Heart rate heart rate immediately after balance condition 1
Secondary Heart rate heart rate Immediately after each singing condition 1-6
Secondary Respiratory rate breaths per minute Baseline measurement prior to all conditions for all participants
Secondary Respiratory rate breaths per minute Immediately after balance condition 1
Secondary Respiratory rate breaths per minute Immediately after each singing condition 1-6
Secondary Borg dyspnoea scale participant completed measure of dyspnoea Baseline assessment prior to all conditions for all participants
Secondary Borg dyspnoea scale participant completed measure of dyspnoea Immediately after balance condition 1
Secondary Borg dyspnoea scale participant completed measure of dyspnoea Immediately after balance condition 2
Secondary Borg dyspnoea scale participant completed measure of dyspnoea Immediately after balance condition 3
Secondary Borg dyspnoea scale participant completed measure of dyspnoea Immediately after each singing condition 1- 6
Secondary Breathing Pattern Assessment Tool Researcher recorded observation of breathing pattern Baseline measurement prior to conditions for all participants
Secondary Mental Readiness Form Measure of state anxiety Immediately after balance condition 1
Secondary Mental Readiness Form Measure of state anxiety Immediately after balance condition 2
Secondary Mental Readiness Form Measure of state anxiety Immediately after balance condition 3
Secondary Mental Readiness Form Measure of state anxiety Immediately after each singing condition 1-6
Secondary Timed Up and Go Measure of physical performance Before any of the singing and balance conditions (baseline measurement (older adults))
Secondary Fall Efficacy Scale International Patient reported outcome measure of risk of falls Before any of the singing and balance conditions a baseline measurement
Secondary State Trait Anxiety Inventory - Y2 Patient reported outcome measure of anxiety Baseline measurement prior to any condition for all participants
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