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Trial registered on ANZCTR


Registration number
ACTRN12620001125910
Ethics application status
Approved
Date submitted
6/08/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can 'strength snacking' offset losses of muscle mass and strength with physical inactivity in older adults?
Scientific title
Can 'strength snacking' offset losses of muscle mass and strength with physical inactivity in older adults?
Secondary ID [1] 301951 0
None.
Universal Trial Number (UTN)
U1111-1256-4804
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 318502 0
Physical inactivity 319280 0
Condition category
Condition code
Musculoskeletal 316505 316505 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 316506 316506 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After one week of daily step count monitoring during their usual activities, participants will be randomly allocated to one of three study groups:

Group 1: Reduced steps
During the inactivity (step reduction) period, participants will be asked to reduce their daily step count by around 65% (to less than 1500 steps per day) compared to their normal daily values.
Participants will be asked to remain as inactive as possible during this period and engage in indoor activities at home requiring minimal physical activity (e.g., reading, watching television).

As per the baseline period, the daily step counts of participants will be monitored using a pedometer worn on their wrist (which you will be asked to record in a logbook), and participant physical activity levels will also be measured using an ActivPAL accelerometer device.

Group 2: Reduced steps plus "strength snacking”
For participants allocated to the "strength snacking” group, "strength snacks” will be performed twice-daily (once in the morning, once in the evening) for 14 days during the reduced steps period.

The "strength snacks” will consist of five bodyweight exercises (such as chair sit-to-stand, single-leg squats, calf raises, step-ups, standing balance, etc.) that will be standardised across all participants. Each exercise will be completed continuously for one minute, and participants will be asked to perform the maximum number of repetitions possible in one minute. One minute of rest will be allowed between each exercise. Each "strength snacking” session will therefore involve only 5 min of exercise (10 minutes total duration).

The "strength snacking” intervention will be delivered to participants and monitored by the research team using a commercial smart device (phone/computer/tablet) application (Physitrack). Participants will receive the program via Physitrack, which will include videos of each exercise, and participants will be asked to record the completion of each exercise and note any relevants comments.

Home-based exercise re-training program:
After the 2-week reduced steps phase, participants in group 1 and 2 will be asked to resume their everyday and physical activity levels and ALL participants (in all 3 groups) will undertake a four-week, home-based exercise re-training program aimed at restoring (or improving) muscle mass and function. This program (including the exercises used and prescription used) will be delivered, performed, and monitored in an identical manner to the "strength snacking” intervention performed during the inactivity period, with the exception that it will be performed twice-daily on every second day for the four-week period.

Retention and adherence:
Retention will be recorded as the number (proportion) of participants that completed the 2-week step reduction intervention and the 4-week follow-up re-training program. Adherence to the exercise program, including the number of sessions completed, and the number of exercises, sets and repetitions completed within each session, will be recorded by participants using the Physitrack app. The exercise program will be considered feasible if at least 90% of participants complete the trial, and if adherence to the exercise program was at least 66%.
Intervention code [1] 318238 0
Rehabilitation
Intervention code [2] 318746 0
Prevention
Comparator / control treatment
Group 3: Usual activity:
Participants allocated to the usual activity group will be asked to continue to undertake their normal everyday activities.
Control group
Active

Outcomes
Primary outcome [1] 324646 0
Bilateral maximal isometric knee extensor strength assessed via isokinetic dynamometry.
Timepoint [1] 324646 0
Immediately before and after the 2-week reduced steps period (primary timepoint), and immediately after the 4-week follow-up exercise program (secondary timepoint).
Secondary outcome [1] 385324 0
Retention [recorded as the number (proportion) of participants that completed the 2-week step reduction intervention and the 4-week follow-up re-training program]. The program will be considered feasible if at least 90% of participants completed the trial.
Timepoint [1] 385324 0
Throughout the 2-week reduced steps and 4-week follow-up exercise program.
Secondary outcome [2] 385325 0
Bilateral grip strength assessed via a handheld dynamometer.
Timepoint [2] 385325 0
Immediately before and after the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [3] 385326 0
Total body fat-free and fat mass [assessed via bioimpedance spectroscopy (BIS)].
Timepoint [3] 385326 0
Immediately before and after the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [4] 385327 0
Total body and regional lean mass and fat mass (assessed via DXA).
Timepoint [4] 385327 0
Immediately before and after the 2-week reduced steps period.
Secondary outcome [5] 385328 0
5 times sit-to-stand (STS) test performance.
Timepoint [5] 385328 0
Immediately before and after the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [6] 385329 0
Subjective health-related quality of life [assessed via the Short Form 36 (SF-36) version 2 and assessment of Quality of Life - 6D questionnaires].
Timepoint [6] 385329 0
Immediately before and after the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [7] 385330 0
Markers of depression, anxiety and stress (assessed via DASS-21 questionnaire).
Timepoint [7] 385330 0
Immediately before and after the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [8] 385331 0
Perceived usability of the Physitrack exercise programming system [assessed via the System Usability Scale (SUS)].
Timepoint [8] 385331 0
Immediately before the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [9] 385332 0
Perception of the "strength snacking" exercise program (assessed via a customised Post-Intervention Evaluation Questionnaire).
Timepoint [9] 385332 0
Immediately before the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [10] 387466 0
Adverse events (defined as an intervention-related event resulting in absence from, or modification to, the exercise intervention). Examples of adverse events include an intervention-related musculoskeletal injury (e.g., muscle or joint injury).
Timepoint [10] 387466 0
During and at the end of the 2 week step reduction intervention, and at the end of the 4 week re-training period.
Secondary outcome [11] 387467 0
Adherence (number of sessions completed, and number of exercises, sets and repetitions completed within each session). The program will be considered feasible if adherence to the program (number of sessions completed as planned) was at least 66%.
Timepoint [11] 387467 0
Throughout the 2-week exercise program completed during the reduced steps period and 4-week follow-up exercise program.
Secondary outcome [12] 387468 0
Timed up-and-go (TUG) test performance.
Timepoint [12] 387468 0
Immediately before and after the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.
Secondary outcome [13] 387469 0
Four square step test performance.
Timepoint [13] 387469 0
Immediately before and after the 2-week reduced steps period, and immediately after the 4-week follow-up exercise program.

Eligibility
Key inclusion criteria
Participants must be: 1) English-speaking, 2) non-smoking, 3) able to walk unaided or with minimal assistance for at least 50 m, 4) cognitively intact as indicated by a score of 2 or less on the Short Portable Mental Status Questionnaire (SPMSQ), and 5) identified as not being at a higher risk of an adverse event during exercise, as determined by the ESSA Adult Pre-exercise Screening System (APSS).
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be ineligible based on the following 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) body mass index (BMI) less than 40 kg/m2, 5) current use of insulin or corticosteroids that could influence skeletal muscle metabolism, 6) musculoskeletal or neurological disorders impacting voluntary movement, 7) upper- or lower-extremity fracture in past three months, 8) presence of moderate-to-strong clinical risk factors (Anderson & Spencer, 2003) for deep vein thrombosis (DVT) (previous hip or knee replacement surgery, arthroscopic knee surgery, major general surgery in previous year, previous venous thromboembolism), or 9) current employment requiring regular standing and/or physical activity.

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)
Central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation.
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
Based on previous research (Reidy et al., 2018), we anticipate that 2 weeks of step reduction (<1500 steps/day) in controls will lead to a ~7% decrease (SD = 12%) in muscle strength. In our previous short-term (12-16 week) resistance training trials in older adults we have observed 20-30% gains in muscle strength. For this study, we have conservatively estimated that 2 weeks of "strength snacks” performed during step reduction will promote a modest 5% increase in muscle strength. Therefore, we estimate that a total of 42 participants (14 in each group) will provide 80% power (two-tailed, a = 0.05) to detect a net difference of 12% in muscle strength between the two strength groups and controls, assuming a 20% drop-out or loss to follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306376 0
University
Name [1] 306376 0
Deakin University
Country [1] 306376 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 306878 0
None
Name [1] 306878 0
Address [1] 306878 0
Country [1] 306878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306574 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 306574 0
Ethics committee country [1] 306574 0
Australia
Date submitted for ethics approval [1] 306574 0
05/01/2020
Approval date [1] 306574 0
30/04/2020
Ethics approval number [1] 306574 0
2020-011

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

Contacts
Principal investigator
Name 104334 0
Dr Jackson Fyfe
Address 104334 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 104334 0
Australia
Phone 104334 0
+613 5227 8779
Fax 104334 0
Email 104334 0
jackson.fyfe@deakin.edu.au
Contact person for public queries
Name 104335 0
Jackson Fyfe
Address 104335 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 104335 0
Australia
Phone 104335 0
+613 5227 8779
Fax 104335 0
Email 104335 0
jackson.fyfe@deakin.edu.au
Contact person for scientific queries
Name 104336 0
Jackson Fyfe
Address 104336 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 104336 0
Australia
Phone 104336 0
+613 5227 8779
Fax 104336 0
Email 104336 0
jackson.fyfe@deakin.edu.au

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
No additional documents have been identified.