NCT05350436

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

March 30, 2022

Last Update Submit

September 15, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (28)

  • Sway frequency (in Hz)

    30 seconds during each balance condition 1

  • Sway frequency (in Hz)

    30 seconds during each balance condition 2

  • Sway frequency (in Hz)

    30 seconds during each balance condition 3

  • Sway frequency (in Hz)

    30 seconds during each singing conditions 1-6

  • Balance-Vigilance Questionnaire

    Immediately after balance condition 1

  • +23 more secondary outcomes

Study Arms (4)

Young adult non singers

EXPERIMENTAL
Behavioral: Balance ConditionsBehavioral: Singing

Young adult singers

EXPERIMENTAL
Behavioral: Balance ConditionsBehavioral: Singing

Older adult non singers

EXPERIMENTAL
Behavioral: Balance ConditionsBehavioral: Singing

Older adult singers

EXPERIMENTAL
Behavioral: Balance ConditionsBehavioral: Singing

Interventions

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.

Older adult non singersOlder adult singersYoung adult non singersYoung adult singers
SingingBEHAVIORAL

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

Older adult non singersOlder adult singersYoung adult non singersYoung adult singers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brunel University London Division of Physiotherapy

Uxbridge, UB8 3PH, United Kingdom

RECRUITING

Related 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. doi: 10.1164/arrd.1982.126.5.825.

    PMID: 7149447BACKGROUND
  • 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. doi: 10.1007/s00221-002-1040-x. Epub 2002 Apr 13.

    PMID: 12021811BACKGROUND
  • 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.

    PMID: 27906158BACKGROUND
  • 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.

    PMID: 20682030BACKGROUND
  • 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.

    PMID: 23145504BACKGROUND
  • 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.

    PMID: 25708268BACKGROUND
  • 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.

    PMID: 32456837BACKGROUND
  • 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):e000737. doi: 10.1136/bmjresp-2020-000737.

    PMID: 33239406BACKGROUND
  • Skingley, A. et al. 'Singing for Breathing': participants' perceptions of a group singing programme for people with COPD. Arts Health 6, 59-74 (2014).

    BACKGROUND
  • 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.

    PMID: 33431879BACKGROUND
  • 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. No abstract available.

    PMID: 29988475BACKGROUND
  • 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.

    PMID: 30758427BACKGROUND
  • 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)

    BACKGROUND
  • World Health Organisation (WHO) (2021). Falls. Available at: https://www.who.int/news-room/fact-sheets/detail/falls (Accessed: 12/01/22)

    BACKGROUND

MeSH Terms

Interventions

Singing

Intervention Hierarchy (Ancestors)

PhonationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Elmar Kal, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Physiotherapy

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 28, 2022

Study Start

February 25, 2022

Primary Completion

April 10, 2023

Study Completion

April 10, 2023

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Other researchers can request access to data on reasonable request via email to the study investigators.

Locations