Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000723583
Ethics application status
Approved
Date submitted
20/05/2024
Date registered
12/06/2024
Date last updated
12/06/2024
Date data sharing statement initially provided
12/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a tailored dance program on health and wellbeing in people aged 65+: a pilot trial
Scientific title
Evaluating the acceptability of a tailored dance program targeting health and wellbeing in people aged 65+: a pilot trial
Secondary ID [1] 312185 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 333841 0
mental wellbeing 333842 0
quality of life 333843 0
social isolation 333844 0
balance impairment 333845 0
physical inactivity 333847 0
fall risk 333848 0
cognitive impairment 333849 0
Condition category
Condition code
Injuries and Accidents 330520 330520 0 0
Other injuries and accidents
Mental Health 330521 330521 0 0
Depression
Mental Health 330522 330522 0 0
Studies of normal psychology, cognitive function and behaviour
Physical Medicine / Rehabilitation 330523 330523 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are testing the feasibility, acceptability and impact of a tailored dance program for supporting health and wellbeing in people aged 65+. Forty people aged 65 and over will be enrolled in the trial once they have been recruited and screened for eligibility. Twenty participants randomised to the intervention group will take part in a 10-week, twice-weekly group-based program of dance classes, each 1 hour and 15 minutes in duration. The classes will be delivered by dance instructors with more than 5 years training and experience in teaching dance to older people.
A dance class will have a maximum of 20 participants. Each class will be performed to music, using jazz/contemporary dance styles and dance routines will be tailored for the individual. Tailoring for the individual will occur within each class based on the instructor’s initial and ongoing observations of the physical capability of each participant. The instructor will provide different levels of difficulty for each of the steps in a routine, for example, a dance done in standing and using the arms may have the option of a wide leg stance, a narrower stance or single leg balance. Another example is when a dance involves repeated sit to stand movements from a chair, 3 different heights of chairs are offered. Participants will be encouraged to choose the version that challenges them but to report any issues to the instructor. Routines will increase in length and complexity across the weeks, but always with more basic options offered. A person-centred, relational approach will underpin the program, with the intention of developing trust and a sense of safety between the teacher and participants. The sessions will challenge cognition through learning, recalling, imagining, coordinating, multi-tasking and creating dance steps. Classes also focus on range of movement, posture, balance, strength, flexibility, coordination, gait, quality of movement, and dynamic movement practice, novel use of body parts and different tempos & rhythms.
This is a single site study, and classes will be held in a community venue in Moreton Bay Council Area.
All intervention participants will be expected to make their own way to and from the venue and participate in the dance classes twice a week for 10 weeks. They will be asked to complete a diary recording any falls or other adverse events that occur during the intervention. All participants will be asked to complete a survey and some brief physical tests before they are randomised, and then again when the 10-week dance program finishes. Once outcome data has been collected for all participants, control group participants will then receive the same 10-week dance program.
Study records will be used to measure the retention of participants, assessed by number of participants who withdrew consent or participation, and instructors will record student attendance. A video recording will be made of one class to ensure fidelity of the program being delivered as it was designed.
Intervention code [1] 328631 0
Lifestyle
Intervention code [2] 328632 0
Prevention
Intervention code [3] 328633 0
Rehabilitation
Comparator / control treatment
Participants randomised to the control group will be waitlisted to receive the same program after follow-up data collection occurs, approximately 11 weeks after baseline data collection.
Control group
Active

Outcomes
Primary outcome [1] 338286 0
The primary outcome is acceptability of the intervention.
Timepoint [1] 338286 0
These questions will be asked at the post-intervention assessment (week 10). For those in the intervention group, this will be commensurate with when they finish the intervention. For those in the wait-list control group, this will be commensurate with the end of their 10-week waiting period (before they receive the intervention).
Primary outcome [2] 338287 0
Acceptability of the trial methods
Timepoint [2] 338287 0
These questions will be asked at the post-intervention assessment (week 10). For those in the intervention group, this will be commensurate with when they finish the intervention. For those in the wait-list control group, this will be commensurate with the end of their 10-week waiting period (before they receive the intervention).
Secondary outcome [1] 435304 0
Feasibility of study methods and intervention design will be measured for both the intervention and waitlist controls.
Timepoint [1] 435304 0
Feasibility will be evaluated upon completion of the study using process indicators gathered during the recruitment period and the study records from the participants and teachers, kept by the research assistant.
Secondary outcome [2] 435305 0
Mental wellbeing
Timepoint [2] 435305 0
Self-administered survey completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.
Secondary outcome [3] 435306 0
Quality of life
Timepoint [3] 435306 0
Self-administered survey completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.
Secondary outcome [4] 435307 0
Social network scale
Timepoint [4] 435307 0
Self-administered survey completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.
Secondary outcome [5] 435308 0
Balance self confidence
Timepoint [5] 435308 0
Self-administered survey completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.
Secondary outcome [6] 435309 0
Dance self-efficacy
Timepoint [6] 435309 0
Self-administered survey completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.
Secondary outcome [7] 435310 0
Physical activity
Timepoint [7] 435310 0
Self-administered survey completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.
Secondary outcome [8] 435311 0
Physical fall risk factors
Timepoint [8] 435311 0
Physical assessment data will be collected by a trained research assistant blinded to the participant group allocation and will be completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.
Secondary outcome [9] 435312 0
Memory
Timepoint [9] 435312 0
Physical assessment data will be collected by a trained research assistant blinded to the participant group allocation and will be completed at baseline and again after 10 weeks for both the intervention and waitlist control groups. A further round of this data will be collected from the waitlist control group when they finish the 10-week dance program.

Eligibility
Key inclusion criteria
Eligible participants will be community-dwelling people aged 65+ who are able to travel to the dance class location and must not have participated in any dance classes in the past 12 months. Participants must be independently mobile (able to walk 10 metres unaided) but be relatively inactive (less than 90 minutes per week of moderate physical activity).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have self-reported medical conditions precluding exercise (e.g., unstable cardiac disease); insufficient English skills to fully participate; impaired cognition (scoring 4 or less on 8-point Memory Impairment Screen); self-assessed inability to walk 10m unassisted; are physically active for more than 90 min per week; or have participated regularly in dance classes in the past year. Screening for eligibility will be via telephone.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following confirmation of eligibility, completion of written informed consent, the participant will receive a study enrolment number, and this will be documented in the all the participant’s study documents. Following completion of baseline self-administered questionnaire and physical assessments, 40 participants will be randomly allocated by a research assistant to the intervention or the waitlist control group in equal numbers. The trial will use a centralised web-based randomisation system using REDCap (Research Electronic Data Capture) within The University of Sydney license to ensure concealment of allocation to groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Centralised web-based randomisation system using REDCap (Research Electronic Data Capture) within The University of Sydney license.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The main analysis will involve descriptive summary statistics for each of the acceptability and feasibility outcome as follows:
1. Acceptability: the proportion of people who would recommend the tailored dance program to another person. We will also calculate the median and interquartile range for affect, burden, perceived effectiveness, and intervention coherence items.
2. Feasibility: a) the rate of recruitment, calculated as the proportion of people who were screened, that were deemed eligible and consented to participation; b) reach, assessed by the representation of sociodemographic characteristics of people screened and who consented; c) the frequency of modes by which people heard about the study; d) retention of participants, assessed by number of participants who withdrew consent or participation; e) frequency and proportion of adverse events; and f) proportion of complete survey questionnaire and physical assessment data.
To assess the impact of the program, we will use linear regression models to compare differences in means and 95% confidence intervals between the trial groups at follow up for the outcome variables, adjusted for the baseline outcome, age, and gender. All analyses will be conducted in SAS Enterprise Guide 9.4 (SAS Institute, Cary, NC, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2024
Actual
Date of last participant enrolment
Anticipated
8/07/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316556 0
Charities/Societies/Foundations
Name [1] 316556 0
Physiotherapy Research foundation
Country [1] 316556 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318738 0
None
Name [1] 318738 0
Address [1] 318738 0
Country [1] 318738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315348 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315348 0
https://www.sydney.edu.au/research/research-integrity-and-ethics.html
Ethics committee country [1] 315348 0
Australia
Date submitted for ethics approval [1] 315348 0
05/02/2024
Approval date [1] 315348 0
24/05/2024
Ethics approval number [1] 315348 0

Summary
Brief summary
Falls are a major health issue for people aged 65+. Participating in regular physical activity which focuses on balance and strength training can reduce the risk of falling, however existing fall prevention exercise programs are not always popular. Tailored dance programs designed for wellbeing and fall prevention are well attended and highly engaging, but as yet there is no evidence that dance prevents falls. We will conduct a pilot RCT of tailored dance classes for people aged 65+, with a waitlist control group, to assess the acceptability, feasibility and impact of a tailored dance intervention. The results will inform the design and methods for a planned large trial of tailored dance classes for older people, with falls as the primary outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134414 0
Dr Heidi Gilchrist
Address 134414 0
School of Public Health, Edward Ford Building A27, University of Sydney, NSW 2006
Country 134414 0
Australia
Phone 134414 0
+61293510919
Fax 134414 0
Email 134414 0
[email protected]
Contact person for public queries
Name 134415 0
Heidi Gilchrist
Address 134415 0
School of Public Health, Edward Ford Building A27, University of Sydney, NSW 2006
Country 134415 0
Australia
Phone 134415 0
+61293510919
Fax 134415 0
Email 134415 0
[email protected]
Contact person for scientific queries
Name 134416 0
Heidi Gilchrist
Address 134416 0
School of Public Health, Edward Ford Building A27, University of Sydney, NSW 2006
Country 134416 0
Australia
Phone 134416 0
+61293510919
Fax 134416 0
Email 134416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



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.