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. 2023 Mar 29;5:42. Originally published 2022 May 26. [Version 2] doi: 10.12688/hrbopenres.13535.2

Table 1. Summary of the key study objectives, outcomes and analysis plans.

Aim Objectives Outcome Criterion for Feasibility Statistical Analysis
Primary Assess feasibility of
recruitment, retention,
group size and data
completion.
Recruitment and retention
rates, missing data.
Music and Movement for Health is feasible.
The rate of participants recruited to the study,
retention rate (the number of participants who
complete measures at baseline and at follow up
post intervention, minimum average attendance
(number of participants who attended at least
65% of the intervention sessions). We will calculate
the minimum outcome assessment target, as
a retention rate of at least 80% of recruited
participants with valid baseline and 12-week
primary outcome data.
To assess if we can recruit and retain
sufficient eligible older adults to inform
a future definitive trial.
Descriptive statistics: mean and SD for
continuous variables proportions for
dichotomous variables.
Assess safety of the programme. Safety: adverse effects e.g.,
falls, a weekly falls log will be
completed.
The programme is safe.
There is no increase in direct adverse events
due to the intervention (e.g., falls during the
intervention period).
Safety assessed through self-report of
direct or unrelated adverse events (e.g.,
falls or pain during the programme
period).
To obtain participants’ & stakeholder
feedback and
experiences of the study processes
and programme.
Qualitative study feedback. Music and Movement for Health is acceptable.
The majority of participants report that the study
processes including measures were feasible and
acceptable.
Thematic analysis. Data regarding
combined completion and acceptability
of measures.
Objective Outcomes Hypothesis Statistical Analysis
Secondary To explore the differences between
the groups for Physical Function,
Balance, Physical Activity, Loneliness,
Social Isolation, Mood,
and Quality of Life.
Results for Clinical outcomes:
Physical Function, Balance,
Physical Activity, Loneliness,
Social Isolation, Mood,
and Quality of Life.
The programme
group will show
improvement in scales.
Regression analysis
To explore the differences between
the groups for Physical Function,
Balance, Physical Activity, Loneliness,
Social Isolation, Mood,
and Quality of Life.
Results for each outcome of
interest.
We can determine the required sample size for a
definitive trial.
ICC (intraclass correlation coefficient)
will be used to calculate the design
effect. Thus, the required sample
size for a CRCT (cluster-randomised
controlled trail) will be calculated by
multiplying the required sample size for
the equivalent ungrouped study with
the DE.
Pilot economic analysis to assess
costs and inform a definitive trial.
A pilot economic analysis
to inform the design and
conduct of a full economic
evaluation to assess the
cost effectiveness of the
programme developed.
The methods developed and implemented for
the conduct of the pilot health economic analysis
proved to be feasible and acceptable to study
participants.
The criterion for success includes
obtaining sufficient data on cost.
Incremental analysis to calculate the
mean differential in costs and QALYs.
The incremental cost effectiveness ratio
(ICER) will be calculated and analysed.
Parametric and probabilistic analyses
will be employed to explore uncertainty.