Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000367448
Ethics application status
Approved
Date submitted
16/03/2016
Date registered
22/03/2016
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Parkinson’s disease: a voice, singing and music study
Scientific title
Acoustic, respiratory, cognitive and wellbeing comparisons of two groups of people with Parkinson’s disease receiving voice and choral singing group therapy or music appreciation activity
Secondary ID [1] 288775 0
None
Universal Trial Number (UTN)
U1111-1180-4361
Trial acronym
VCSTRCT
Voice Choral Singing Therapy Random Control Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 298038 0
Condition category
Condition code
Neurological 298195 298195 0 0
Parkinson's disease
Neurological 298196 298196 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Voice and Choral Singing Group Therapy. Group sessions will be led by an experienced clinician Speech Language Therapist and musician. Activities will consist of respiratory, phonatory, oro-motor and relaxation exercise and singing a selection of songs. The group sessions will take place once a week for one and a half hours weekly over 9 continuous weeks. Adherence will be monitored using a register of attendance at each session.
Intervention code [1] 294218 0
Prevention
Intervention code [2] 294219 0
Lifestyle
Intervention code [3] 294238 0
Treatment: Other
Comparator / control treatment
Music Appreciation Activity. Group sessions will be led by an experienced clinician Speech Language Therapist and musician. A weekly social interaction group will listen to the same music as the intervention and discuss music without singing. The group sessions will take place once a week for one and a half hours weekly over 9 continuous weeks. Adherence will be monitored using a register of attendance at each session.
Control group
Active

Outcomes
Primary outcome [1] 297701 0
Voice amplitude
Voice/speech levels will be measured using a sound level meter (SLM) (CEL-244 Digital Integrating Sound Level Meter Class 2, Casella).
Three acoustic values:
1. Slow, C-weighted sound level (LCS)
2. Average, C-weighted sound level (Lceq)
3. Maximum sound level (Lmx)
Timepoint [1] 297701 0
Baseline and end of intervention (9 weeks)
Primary outcome [2] 297703 0
Maximum phonation time (secs)
Voice samples captured for MPT will be edited and analysed using the Multi Dimensional Voice Programme.
The recordings (44.1 kHz sampling rate, 16 bit) will be captured using an AKG C410 (Harman International, Austria) head mounted condenser microphone connected to a 24-bit/96kHz audio interface with preamp (M-Audio Mobile Pre USB) and recorded digitally. Acoustic analysis of all the speech samples will be completed using Sona-Speech II 'Trademark' Software (KayPENTAX).
Timepoint [2] 297703 0
Baseline and at end of intervention (9 weeks).
Primary outcome [3] 297704 0
Voice quality (jitter, Shim)
Voice samples captured for voice quality will be edited and analysed using the Multi Dimensional Voice Programme.
Programme (MDVP). Spectral analysis will include:
1. Average Fundamental Frequency (Ave F0)
2. Relative Average Perturbation (RAP)
3. Shimmer %-Shim (Shim)
4. Fundamental Frequency Variation (vF0)

As well as these data, further data analysis of prosody will include:
1. Mean Fundamental Frequency (MeanF0) in Hertz (Hz)
2. Standard Deviation (SD)
3. Variance in Fundamental Frequency (vF0)
4. Semi-tones (STR)
5. Standard Deviation Semitone (SDS)

The recordings and spectral analysis using (44.1 kHz sampling rate, 16 bit) will be captured using an AKG C410 (Harman International, Austria) head mounted condenser microphone connected to a 24-bit/96kHz audio interface with preamp (M-Audio Mobile Pre USB) and recorded digitally. Acoustic analysis of all the speech samples will be completed using Sona-Speech II 'Trademark' Software (KayPENTAX).
Timepoint [3] 297704 0
Baseline and at end of intervention (9 weeks).
Secondary outcome [1] 321915 0
Voice VHI-10 + VHI-10P
Using the Voice Handicap Index
Timepoint [1] 321915 0
Baseline and at end of intervention (9 weeks).
Secondary outcome [2] 321917 0
Quality of Life
Using Parkinson’s disease quality of life Scale PDQ-8
Timepoint [2] 321917 0
Baseline and at end of intervention (9 weeks).
Secondary outcome [3] 321920 0
Depression Anxiety
Using Depression Anxiety Stress Scales DASS-21
Timepoint [3] 321920 0
Baseline and at end of intervention (9 weeks).
Secondary outcome [4] 321921 0
Cognitive Impairment
Using the Addenbrookes Cognitive Examination ACE-III (NZed)
Timepoint [4] 321921 0
Baseline and at end of intervention (9 weeks).
Two NZ variants (1. Baseline, 2. Post)
Secondary outcome [5] 321922 0
ADLs/functional Motor and Non-Motor
This is a composite outcome measure. Using the MDS-UPDRS Patient self-evaluation questionnaire
Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL)
Part II: Motor Aspects of Experiences of Daily Living (M-EDL)
Timepoint [5] 321922 0
Baseline and at end of intervention (9 weeks).
Secondary outcome [6] 321923 0
Participant questionnaire
This is a composite outcome measure. To determine participant views on enjoyment, engagement, meaningfulness of participation. Questionnaire adapted from (Fogg & Talmage 2011).
Timepoint [6] 321923 0
End of intervention
Secondary outcome [7] 323224 0
This is a composite primary outcome.
Respiration and subglottic pressure will also be measured using a Phonatory Aerodynamic System (PAS) which calculates: Average phonatory flow rate, Vital capacity, Glottal resistance and Subglottal pressure.
Timepoint [7] 323224 0
Baseline and at end of intervention (9 weeks).

Eligibility
Key inclusion criteria
All participants will have idiopathic Parkinson’s disease diagnosed by a Consultant Neurologist and will not have any other neurological disorder other than PD. Participants will have no singing or VCST in the previous 12 months before the study treatment period.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant psychiatric history (e.g., Schizophrenia, Bipolar affective disorder), Moderate to severe traumatic brain injury, Intellectual disability, known significant cerebral infarct (Stroke), Significant neurological condition (e.g., epilepsy, intracerebral tumor), blind or deaf, Significant alcohol / substance abuse / dependence.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to participate in the trial through advertisements in Parkinson's Society and Centre for Brain Research newsletters and through referral from consultant neurologists and general practitioners.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Interested participants will will receive the participant information sheet by post. They will be invited to a 30-minute meeting to fully discuss the trial and establish written informed consent.

Consenting and eligible participants will be invited to participate in the study activities and proceed with baseline self reported assessments.
The researchers will liaise with an off site colleague from the University of Auckland who is not involved in this trial, who will use a computer generated randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation): a computer generated randomisation schedule to allocate participants to one of two groups using stratified randomisation to uphold balance of: sex, age, cognitive screen scores and secondary outcomes between groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2016
Actual
16/09/2016
Date of last participant enrolment
Anticipated
26/07/2018
Actual
23/09/2016
Date of last data collection
Anticipated
Actual
28/04/2017
Sample size
Target
37
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 7709 0
New Zealand
State/province [1] 7709 0
Auckland

Funding & Sponsors
Funding source category [1] 293142 0
University
Name [1] 293142 0
University of Auckland
Country [1] 293142 0
New Zealand
Primary sponsor type
University
Name
University
Address
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291937 0
None
Name [1] 291937 0
None
Address [1] 291937 0
Country [1] 291937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294639 0
Health and Disability Ethics Committee
Ethics committee address [1] 294639 0
Ethics committee country [1] 294639 0
New Zealand
Date submitted for ethics approval [1] 294639 0
21/04/2016
Approval date [1] 294639 0
23/05/2016
Ethics approval number [1] 294639 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64442 0
Mr Robin Matthews
Address 64442 0
University of Auckland
Department of Psychology
Tamaki Campus (Rm 721.319)
261 Morrin Road,
Glen Innes 1072
Auckland 1010
Country 64442 0
New Zealand
Phone 64442 0
+6475434461
Fax 64442 0
Email 64442 0
[email protected]
Contact person for public queries
Name 64443 0
Suzanne Purdy
Address 64443 0
University of Auckland
Head: Discipline of Speech Science
Department of Psychology
Tamaki Campus (Rm 721.319)
261 Morrin Road,
Glen Innes 1072
Auckland 1010
Country 64443 0
New Zealand
Phone 64443 0
+64 9 373 7599
Fax 64443 0
Email 64443 0
[email protected]
Contact person for scientific queries
Name 64444 0
Suzanne Purdy
Address 64444 0
University of Auckland
Head: Discipline of Speech Science
Department of Psychology
Tamaki Campus (Rm 721.319)
261 Morrin Road,
Glen Innes 1072
Auckland 1010
Country 64444 0
New Zealand
Phone 64444 0
+64 9 373 7599
Fax 64444 0
Email 64444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.