Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000236897
Ethics application status
Approved
Date submitted
13/01/2021
Date registered
5/03/2021
Date last updated
3/02/2023
Date data sharing statement initially provided
5/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing effectiveness of Weight loss and Exercise programs for older adults with Sarcopenic Obesity delivered via MobilE application/s
Scientific title
The effect of a dietary intervention combined with functional intensity training delivered by mobile application on physical function, bone quality, and insulin sensitivity in older adults with sarcopenic obesity
Secondary ID [1] 303156 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenic Obesity 320277 0
Condition category
Condition code
Musculoskeletal 318206 318206 0 0
Other muscular and skeletal disorders
Diet and Nutrition 318474 318474 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the 24-week intervention period, all participants will follow the dietary intervention, and equal numbers will be randomised to either home-based Functional Intensity Training (FIT) or home-based aerobic exercise (control) as described below

All participant’s diet will be modified by deducting 750 - 1000 kcal from their habitual intake, aiming for at least ~1.0 kg reduction in total body fat per week.

Each participant will be oriented via an initial 30-40 minutes telephone consult by the study dietitian on how to quantify their intake using portion sizes and guides (i.e. balanced plate, household measures e.g. measuring cups and weight) and replacing energy-dense foods with those of lower energy density by tailoring their intake to reduce 2.1 MJ/day for a weight loss of 0.5-1kg per week. Appropriate dietary information will be selected by the dietitian using the clinician interface in Physitrack and individually broadcast to participants smart phone via the clinician interface in Physitrack at specified times throughout the day, using video demonstrations, and audio and written instructions designed by study investigators specifically for this study. Following each dietary advice, the Physitrack will broadcast questions to determine whether the participant adhered to the kilojoule reduction intervention. Participants’ responses to these questions will be recorded and saved to the Physitrack database, enabling the dietitian to review weekly and modify or progress the information as required. The study dietitian will also conduct follow up telephone interviews for 20 minutes once a fortnight for weeks 2, 4, 6 and 8, and reducing the follow up calls to monthly (weeks 12, 16 and 20) throughout the intervention to monitor and review dietary intakes and set behavioural goals. In total there will be 16 dietary videos, 1 initial phone consult and 7 follow up phone consults throughtout the intervention.

Participants allocated to the FIT group in the present study will be given a structured 24-week, 30-minute, home-based FIT program delivered by a commercial telehealth platform Physitrack. However, each participant is also able to complete their exercise program at a local gymnasium at their own expense. All exercises will be individually-tailored and progressive, considering initial fitness, injuries or illness. Appropriate activities will be selected by the exercise physiologists using the clinician interface in Physitrack and individually broadcast to participants smart phone via the clinician interface in Physitrack at specified times throughout the day, using video demonstrations, and audio and written instructions designed by study investigators specifically for this study. Following each exercise, the Physitrack will broadcast questions to determine whether the participant completed the exercise, their self-perceived exertion, and any concerns (e.g. Pain, dizziness). Participants’ responses to these questions will be recorded and saved to the Physitrack database, enabling the exercise physiologist to review weekly and modify or progress exercise prescriptions as required.

The prescribed exercise program will use body weight or additional resistance such as weight plates, dumbbells, theraband, weight vests etc if the participant has access to them unless contraindicated. In each session, participants will perform 1 set of 10 repetitions of five exercises (1 strength-focused, 1- balance-focused, and 3 impact-focused) at a low intensity of approximately 1-3 on the 10-point modified Rating of Perceived Exertion (RPE) scale to serve as a warm-up as required. Participants will be then required to perform 5 sets of 10-20 repetitions, at a moderate-intensity of approximately 4-6 on the 10-point modified Rating of Perceived Exertion (RPE) scale. Each participant will be encouraged to increase the load of all the prescribed exercises each session while maintaining the desired intensity if able. The protocol will initially deliver three exercise sessions per week for the first eight weeks of the intervention, four exercise sessions per week for the second eight weeks, and five exercise sessions per week for the final 8 weeks.
Intervention code [1] 319465 0
Lifestyle
Intervention code [2] 319668 0
Treatment: Other
Comparator / control treatment
The Control group will also receive the same dietary intervention as the intervention group.

The control group will complete a moderate-intensity, home-based aerobic exercise program for 24 weeks. The intervention will be provided at week 1 of the intervention, however will not be supervised for the duration of the 24 week intervention.
Participants will aim to complete 30 minutes of exercise each day, 5 days a week to accumulate up to 150mins/week of walking/jogging at moderate intensity, based on self-perceived exertion reported on the Borg scale at a range of 11 to 13 out of 20 intensity and maintain this for the duration of the home-based intervention. Self reported log books will be provided to measure adherence of the intervention at baseline for the duration of the 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 326193 0
Change in Muscular Power (Vertical Jump (W/kg) as assessed by a Leonardo Mechanography Ground Reaction Force Platform
Timepoint [1] 326193 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [1] 390437 0
25-hydroxyvitamin D as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [1] 390437 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [2] 390438 0
Glucose as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [2] 390438 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [3] 390439 0
Insulin as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [3] 390439 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [4] 390440 0
Triglycerides as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [4] 390440 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [5] 390441 0
HDL cholesterol as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [5] 390441 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [6] 390442 0
LDL cholesterol as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [6] 390442 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [7] 390443 0
C-Reactive protein as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [7] 390443 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [8] 390444 0
Type 1 C-Telopeptide as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [8] 390444 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [9] 390445 0
Type 1 Procollagen N-Terminal as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [9] 390445 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [10] 390446 0
Total body fat percentage as assessed by a dual-energy X-ray absorptiometry
Timepoint [10] 390446 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [11] 390447 0
Anterior-posterior spine bone mineral density (T-score) as assessed by a dual-energy X-ray absorptiometry
Timepoint [11] 390447 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [12] 390448 0
Total hip bone mineral density (T-score) as assessed by a dual-energy X-ray absorptiometry
Timepoint [12] 390448 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [13] 390449 0
Total body bone mineral density (T score) as assessed by a dual-energy X-ray absorptiometry
Timepoint [13] 390449 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [14] 390450 0
Total tibial bone mineral density as assessed by a High-resolution Peripheral Quantitative Computed Tomography
Timepoint [14] 390450 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [15] 390451 0
Hand Grip Strength (kg) as assessed by a Jamar hydraulic hand grip dynamometer
Timepoint [15] 390451 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [16] 390452 0
Stair climb power as assessed by the Stair Climb Power Test (min)
Timepoint [16] 390452 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [17] 390453 0
Physical performance and disability as assessed by the Short Physical Performance Battery
Timepoint [17] 390453 0
Baseline, follow-up (24 weeks post-intervention commencement)
Secondary outcome [18] 390454 0
Quality of life as assessed by CDC Healthy Days Questionnaire
Timepoint [18] 390454 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [19] 390455 0
Quality of Life as assessed by EuroQol-5D-5L
Timepoint [19] 390455 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [20] 390456 0
Quality of life for people with sarcopenia as assessed by Sarcopenia Quality of Life

Timepoint [20] 390456 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [21] 390457 0
Falls efficacy as assessed by Modified Falls Efficacy Scale
Timepoint [21] 390457 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [22] 390458 0
objective assessment of physical activity as assessed by actigraph wGT9XLink accelerometer. Physical activity data measured will be steps/day, moderate and vigorous activity.
Timepoint [22] 390458 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [23] 392525 0
Objective assessment of sedentary time will be assessed by actigraph wGT9XLink accelerometer. Sedentary data will be sedentary time.
Timepoint [23] 392525 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [24] 392526 0
objective assessment of sleep time will be assessed by actigraph wGT9XLink accelerometer. Sleep data measured will be sleep time
Timepoint [24] 392526 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [25] 405598 0
Objective assessment of hypersensitivity will be assessed by commander Echo digital algometer
Timepoint [25] 405598 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [26] 405599 0
Musculoskeletal pain intensity as measured by the visual analogue scale for musculoskeletal pain intensity
Timepoint [26] 405599 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [27] 405600 0
Pain Catastrophizing as measured by the Pain Catastrophizing Scale.
Timepoint [27] 405600 0
Baseline, 12 weeks and 24 weeks post-intervention commencement
Secondary outcome [28] 405601 0
Evaluation of the burden of Osteoarthritis by the The Western Ontario McMaster Osteoarthritis Index
Timepoint [28] 405601 0
Baseline, 12 weeks and 24 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Prospective participants must be aged 60-89 years; English-speaking; have a body mass index greater than or equal to 30 kg/m2, score 2 greater than or equal to on the SARC-F questionnaire, able to walk across a room unaided; with access to a smartphone connected to an internet network; willing to complete a 24-week weight loss intervention and also be willing to participate should they be randomised to either intervention arm.
Minimum age
60 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are ineligible if they currently reside in a nursing home; are unable to walk across a room are non-English speaking or have difficulty communicating with study personnel due to speech or hearing problems; report less than or equal to 4 weeks self-reported participation in a supervised exercise or dietary program targeted at weight loss or strength gains in the past six months; taking any medication or supplements that facilitate weight loss; are planning to be away from home for less than or equal to 4 weeks during the intervention; and self-reported diagnosis of: progressive neurological disorders including Parkinson’s Disease and multiple sclerosis; schizophrenia or bipolar disorder; severe knee or hip osteoarthritis (awaiting or have had a joint replacement) that would interfere with ability to complete functional exercise and tests; cardiovascular disease (including NYHA Class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable cardiac defibrillator, or uncontrolled angina); lung disease requiring regular use of corticosteroids or supplemental oxygen; renal disease requiring dialysis; hyper- or hypothyroidism that would interfere with the weight loss program; and any other disorder of such severity that life expectancy is less than 12 months. or any cognitive or physical impairment or disability that in the opinion of the participant’s’ GP/specialist and/or study investigators would result in the participant having difficulty interacting with the Physitrack application or performing unsupervised exercise safely. Finally, participants must answer ‘no’ to all six questions on the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool to ensure that it is safe for them to exercise at moderate exertion. This is a validated and recommended pre-exercise screening tool endorsed by Australia’s peak exercise body (ESSA).

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)
An independent statistician responsible for central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to home-based FIT or home-based aerobic exercise (control) using computer-generated block randomisation of numbers.
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
Efficacy
Statistical methods / analysis
We will recruit a total sample size of 116 subjects (equal numbers of males and females), with 58 allocated to each arm. Adjusting for a loss to follow-up of 20%, this sample size is large enough to detect a clinically meaningful 4 W/kg (6 W/kg SD) difference in maximal vertical jump between the FIT and control group.

At the completion of the study, all data will be entered into a secure Microsoft Access database. Data will be exported to an SPSS file and each variable inspected for data errors. In the case of missing or spurious data, original files will be consulted to identify the correct values. When correct values cannot be confirmed, the data point will be classified as missing. Non-normal data will be transformed to meet normality assumptions of parametric methods, or non-parametric methods will be used where appropriate. Independent samples t-tests and Mann-Whitney U tests will be used to compare baseline and change values for physical function, body composition and bone parameters between the and control groups. For all analyses, a P-value of <0.05 or 95% confidence interval not including the null point will be considered statistically significant. All data will be analysed using SPSS Statistics Version 24 (IBM, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2022
Actual
2/02/2022
Date of last participant enrolment
Anticipated
7/08/2023
Actual
Date of last data collection
Anticipated
7/02/2024
Actual
Sample size
Target
116
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18412 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 32507 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 307564 0
Government body
Name [1] 307564 0
NHMRC
Country [1] 307564 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Bennettswood Victoria 3125
Country
Australia
Secondary sponsor category [1] 308250 0
University
Name [1] 308250 0
Monash University
Address [1] 308250 0
Monash University
Level 7, TRF Building, Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Australia
Country [1] 308250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307624 0
Monash Health Ethics Committee
Ethics committee address [1] 307624 0
Ethics committee country [1] 307624 0
Australia
Date submitted for ethics approval [1] 307624 0
11/01/2021
Approval date [1] 307624 0
05/11/2021
Ethics approval number [1] 307624 0

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

Contacts
Principal investigator
Name 107902 0
A/Prof David Scott
Address 107902 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 107902 0
Australia
Phone 107902 0
+61 3 9246 8438
Fax 107902 0
Email 107902 0
[email protected]
Contact person for public queries
Name 107903 0
David Scott
Address 107903 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 107903 0
Australia
Phone 107903 0
+61 3 9246 8438
Fax 107903 0
Email 107903 0
[email protected]
Contact person for scientific queries
Name 107904 0
David Scott
Address 107904 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 107904 0
Australia
Phone 107904 0
+61 3 9246 8438
Fax 107904 0
Email 107904 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 de-identified participant data collected during the trial
When will data be available (start and end dates)?
Data will be available at the end of the trial and there is no end date for data availability
Available to whom?
Data obtained from this study will be made available to other researchers by approval from PI Associate Professor David Scott.
Available for what types of analyses?
Secondary analysis
Meta analysis
How or where can data be obtained?
Data obtained from this study will be made available to other researchers by approval from PI Associate Professor David Scott.
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
+61 3 9246 8438 / +61 4 0952 1629
[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.