Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001538831
Ethics application status
Approved
Date submitted
12/10/2021
Date registered
10/11/2021
Date last updated
10/11/2021
Date data sharing statement initially provided
10/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and effects of a pragmatic home-based resistance ‘exercise snacking’ program on physical function in older adults living independently.
Scientific title
Feasibility, acceptability, and dose-response effects of a remotely delivered, home-based, pragmatic resistance ‘exercise snacking’ intervention on physical function in community-dwelling older adults: A pilot randomised controlled trial.
Secondary ID [1] 305524 0
None.
Universal Trial Number (UTN)
U1111-1270-3566
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 323923 0
Condition category
Condition code
Musculoskeletal 321437 321437 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants completed home-based resistance ‘exercise snacking’ sessions either once, twice, or thrice daily for four weeks (i.e., the once-daily, twice-daily, and thrice-daily groups). Over four weeks, participants were therefore prescribed a total of 28, 56, or 84 resistance 'exercise snacking' sessions (for the once-daily, twice-daily, and thrice-daily groups, respectively).

Each resistance ‘exercise snacking’ session consisted of five exercises, with each exercise performed continuously for one minute, with one minute of passive recovery between each exercise (i.e., total time commitment of nine minutes per session).

The exercise intervention was remotely delivered (by a member of the research term with expertise in exercise science and physiology) via a commercially available, web-based exercise programming application (PhysiTrackTM) and accompanying end-user application (PhysiAppTM) accessible to participants via a computer, smart phone, or tablet.

For this pilot study, PhysiTrackTM and PhysiAppTM were used only for the purposes of delivering the exercise program to participants, including both written instructions and video demonstrations of how to complete each exercise in the program.

Immediately after completing each resistance ‘exercise snacking’ session, participants recorded in an exercise diary whether they successfully completed the session (yes or no), their RPE (Rating of Perceived Exertion) using the CR-10 (category ratio 10) scale, and whether any adverse events were experienced.

Participant retention was recorded as the number (proportion) of participants who were randomised and completed both the four-week exercise intervention (or control period) and follow-up assessments. Adherence to the exercise intervention was considered as the number of sessions completed as a proportion of the number of planned (prescribed) sessions, which was self-reported by participants via an exercise diary. In addition, exercise adherence was also reported as the prescribed versus actual (completed) based on the following: i) number of days exercised per week, ii) total number (frequency) of ‘exercise snacks’ per week, and iii) total number of ‘exercise snacks’ during the four-week intervention. The exercise intervention was considered feasible if participant retention was at least 90%, and if participants completed a mean of 80% of prescribed sessions.
Intervention code [1] 321931 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group were required to maintain their usual levels of physical activity during the four-week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 329218 0
Intervention feasibility (as determined by participant retention and adherence to the exercise intervention assessed via an exercise diary).
Timepoint [1] 329218 0
Follow-up (immediately after completion of 4-week intervention).
Primary outcome [2] 329219 0
Intervention acceptability (as determined using a study-specific online questionnaire).
Timepoint [2] 329219 0
Follow-up (immediately after completion of 4-week intervention).
Secondary outcome [1] 401805 0
Physical function (balance testing battery).
Timepoint [1] 401805 0
Baseline and follow-up (immediately after completion of 4-week intervention).
Secondary outcome [2] 402808 0
Physical function [five-times sit-to-stand (5-STS) test].
Timepoint [2] 402808 0
Baseline and follow-up (immediately after completion of 4-week intervention).
Secondary outcome [3] 402809 0
Physical function [30-second sit-to-stand (30-STS) test].
Timepoint [3] 402809 0
Baseline and follow-up (immediately after completion of 4-week intervention).
Secondary outcome [4] 402810 0
Feasibility of remote physical function assessments (proportion of particicants that could successfuly complete each assessment at baseline and follow-up).
Timepoint [4] 402810 0
Baseline and follow-up (immediately after completion of 4-week intervention).

Eligibility
Key inclusion criteria
1) English-speaking, 2) non-smoking, 3) able to walk unaided or with minimal assistance for greater than or equal to 50 m, 4) cognitively intact as indicated by a score of less than or equal to 2 on the Short Portable Mental Status Questionnaire (SPMSQ), and 5) had access to a computer, smart phone or tablet device with a stable network or internet/WiFi connection.
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Participating in structured resistance training more than once per week in the previous three months, 2) acute or terminal illness likely to impact study involvement, 3) unstable or ongoing cardiovascular, metabolic, or respiratory disorders, 4) current use of insulin or corticosteroids that could influence skeletal muscle metabolism, 5) self-reported body mass index (BMI) greater than or equal to 40 kg·m-2, 6) musculoskeletal or neurological disorders impacting voluntary movement, or 7) inability to commit to the study and its requirements.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this was a pilot feasibility study, a convenience sample of 38 older adults was recruited, and no formal sample size calculations nor statistical analyses were performed. All baseline and follow-up data are presented as means ± SDs and all change data are reported as means with 95% confidence intervals (CIs), unless otherwise stated, to allow readers to judge the weight (strength) of any effects. In addition, effect sizes (Cohen’s d) for within-group changes between baseline and week 4 were calculated according to the following formula: mean follow-up score minus mean baseline score divided by baseline standard deviation. The magnitude of ES values was interpreted as < 0.2 = trivial, 0.2 to < 0.5 = small, 0.5 to < 0.8 = moderate, and greater than or equal to 0.8 = large. Mean changes, ES values, and associated 95% CIs were calculated using JASP software (Version 0.14.1, JASP Team, The Netherlands).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2020
Date of last participant enrolment
Anticipated
Actual
2/11/2020
Date of last data collection
Anticipated
Actual
14/12/2020
Sample size
Target
40
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309893 0
University
Name [1] 309893 0
Deakin University
Country [1] 309893 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 310933 0
None
Name [1] 310933 0
Address [1] 310933 0
Country [1] 310933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309617 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309617 0
Ethics committee country [1] 309617 0
Australia
Date submitted for ethics approval [1] 309617 0
02/10/2020
Approval date [1] 309617 0
27/10/2020
Ethics approval number [1] 309617 0
2020-011

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

Contacts
Principal investigator
Name 114786 0
Dr Jackson Fyfe
Address 114786 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 114786 0
Australia
Phone 114786 0
+613 5227 8779
Fax 114786 0
Email 114786 0
[email protected]
Contact person for public queries
Name 114787 0
Jackson Fyfe
Address 114787 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 114787 0
Australia
Phone 114787 0
+613 5227 8779
Fax 114787 0
Email 114787 0
[email protected]
Contact person for scientific queries
Name 114788 0
Jackson Fyfe
Address 114788 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 114788 0
Australia
Phone 114788 0
+613 5227 8779
Fax 114788 0
Email 114788 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?

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
SourceTitleYear of PublicationDOI
EmbaseFeasibility and acceptability of a remotely delivered, home-based, pragmatic resistance 'exercise snacking' intervention in community-dwelling older adults: a pilot randomised controlled trial.2022https://dx.doi.org/10.1186/s12877-022-03207-z
N.B. These documents automatically identified may not have been verified by the study sponsor.