Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001136897p
Ethics application status
Submitted, not yet approved
Date submitted
14/07/2021
Date registered
23/08/2021
Date last updated
23/11/2022
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a Musculoskeletal-targeted Exercise and nutrition TElehealth program for Older women following bariatRIC surgery (METEORIC Trial)
Scientific title
Feasibility of a Musculoskeletal-targeted Exercise and nutrition TElehealth program for Older women following bariatRIC surgery (METEORIC Trial)
Secondary ID [1] 304752 0
Nil known
Universal Trial Number (UTN)
Trial acronym
METEORICS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 322794 0
Condition category
Condition code
Diet and Nutrition 320387 320387 0 0
Obesity
Musculoskeletal 320394 320394 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the Functional Impact Training group in the present study will be given a structured 32-week, 30-minute, home-based Functional Impact Training program delivered by a commercial telehealth smartphone app (Physitrack). 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. Following each exercise, 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 adjustable dumbbells, which will be provided. Participants will perform up to 1 set of 10 repetitions of all 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 sixteen weeks.

General information on nutrition for musculoskeletal health will be presented fortnightly via Physitrack. The content delivered will be prepared by our dietitian colleagues and cover the following topic areas: “Bone Health and Bariatric Surgery”, “Dairy”, “Dairy Alternatives”, “Calcium”, “Protein”, “Vitamin D”, “Maintaining Healthy Diet Behaviours”, and “Overcoming Diet Setbacks” The delivery of information to patients will involve short (2-3 minute)
educational videos as well as PDF information sheets and nutritional suggestions for increasing dairy, vitamin D and protein intake including examples of appropriate foods, meals and recipes. On a monthly basis, participants will receive questions via Physitrack to determine participants’ learning and adherence to recommendations.
Intervention code [1] 321133 0
Lifestyle
Intervention code [2] 321134 0
Treatment: Other
Comparator / control treatment
The control group will receive monthly information updates via Physitrack in the form of PDF documents. This information will be based on current literature
provided to bariatric surgery patients regarding dietary and exercise needs, will not be personalised and will not have a focus on musculoskeletal health. It
is not expected that the delivery of information in this manner will result in behaviour change.
Control group
Active

Outcomes
Primary outcome [1] 328220 0
Feasibility data on adherence to the intervention assessed by Physitrack app usage data and analytics
Timepoint [1] 328220 0
Baseline and 32 weeks (end intervention)
Primary outcome [2] 328465 0
Feasibility data for exercise safety assessed by participant interviews and feedback.
The interview will be a 1-hour semi-structured phone interview, with questions eliciting responses about participant motivation, capacity and opportunity to adhere to the intervention. Feedback will be acquired throughout the interview.
Timepoint [2] 328465 0
Baseline and 32 weeks (end intervention)
Primary outcome [3] 328466 0
Feasibility data for participant retention assessed by Physitrack app usage data and analytics and participant interviews.
The interview will be a 1-hour semi-structured phone interview, with questions eliciting responses about participant motivation, capacity and opportunity to adhere to the intervention. Feedback will be acquired throughout the interview.
Timepoint [3] 328466 0
Baseline and 32 weeks (end intervention)
Secondary outcome [1] 398131 0
Changes to bone mineral density as assessed by Dual-energy X-ray absorptiometry
Timepoint [1] 398131 0
Baseline and 32 weeks (end intervention)
Secondary outcome [2] 398187 0
Changes in muscular power as assessed by a Leonardo Mechanography Ground Reaction Force Platform
Timepoint [2] 398187 0
Baseline and 32 weeks (end intervention)
Secondary outcome [3] 398188 0
Changes in physical function as assessed by Short Physical Performance Battery
Timepoint [3] 398188 0
Baseline and 32 weeks (end intervention)
Secondary outcome [4] 398189 0
25-hydroxyvitamin D as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [4] 398189 0
Baseline and 32 weeks (end intervention)
Secondary outcome [5] 398190 0
Glucose as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [5] 398190 0
Baseline and 32 weeks (end intervention)
Secondary outcome [6] 398191 0
Insulin as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [6] 398191 0
Baseline and 32 weeks (end intervention)
Secondary outcome [7] 398192 0
Triglycerides as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [7] 398192 0
Baseline and 32 weeks (end intervention)
Secondary outcome [8] 398193 0
HDL cholesterol as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [8] 398193 0
Baseline and 32 weeks (end intervention)
Secondary outcome [9] 398194 0
LDL cholesterol as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [9] 398194 0
Baseline and 32 weeks (end intervention)
Secondary outcome [10] 398195 0
C-Reactive protein as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [10] 398195 0
Baseline and 32 weeks (end intervention)
Secondary outcome [11] 398196 0
Type 1 C-Telopeptide as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [11] 398196 0
Baseline and 32 weeks (end intervention)
Secondary outcome [12] 398197 0
Type 1 Procollagen N-Terminal as assessed by 10mL fasting blood sample taken by a qualified technician
Timepoint [12] 398197 0
Baseline and 32 weeks (end intervention)
Secondary outcome [13] 398198 0
Total body fat percentage as assessed by a dual-energy X-ray absorptiometry
Timepoint [13] 398198 0
Baseline and 32 weeks (end intervention)
Secondary outcome [14] 398199 0
Anterior-posterior spine bone mineral density (T-score) as assessed by a dual-energy X-ray absorptiometry
Timepoint [14] 398199 0
Baseline and 32 weeks (end intervention)
Secondary outcome [15] 398200 0
Total hip bone mineral density (T-score) as assessed by a dual-energy X-ray absorptiometry
Timepoint [15] 398200 0
Baseline and 32 weeks (end intervention)
Secondary outcome [16] 398201 0
Total body bone mineral density (T score) as assessed by a dual-energy X-ray absorptiometry
Timepoint [16] 398201 0
Baseline and 32 weeks (end intervention)
Secondary outcome [17] 398202 0
Total tibial bone mineral density as assessed by a High-resolution Peripheral Quantitative Computed Tomography
Timepoint [17] 398202 0
Baseline and 32 weeks (end intervention)
Secondary outcome [18] 398203 0
Pain Pressure Threshold at the forearm, paraspinals and calf using standard and reliable protocols based off two of JV. Oosterwijck's experimental studies: "Van Oosterwijck J, Nijs J, Meeus M, Van Loo M, Paul L. Lack of endogenous pain inhibition during exercise in people with chronic whiplash associated disorders: an experimental study. The Journal of Pain. 2012;13(3):242-54." and "Van Oosterwijck J, Nijs J, Meeus M, Lefever I, Huybrechts L, Lambrecht L, et al. Pain inhibition and postexertional malaise in myalgic encephalomyelitis/chronic fatigue syndrome: An experimental study. Journal of Internal Medicine. 2010;268(3):265-78."
Timepoint [18] 398203 0
Baseline and 32 weeks (end intervention)
Secondary outcome [19] 398204 0
Objective Physical Activity Assessments, assessed using an Activegraph accelerometer
Timepoint [19] 398204 0
Baseline and 32 weeks (end intervention)
Secondary outcome [20] 398205 0
Quality of life as assessed by CDC Healthy Days Questionnaire
Timepoint [20] 398205 0
Baseline and 32 weeks (end intervention)
Secondary outcome [21] 398206 0
Quality of life as assessed by International Physical Activity Questionnaire for the Elderly
Timepoint [21] 398206 0
Baseline and 32 weeks (end intervention)
Secondary outcome [22] 398207 0
Quality of life as assessed by the visual analogue scale for musculoskeletal pain intensity
Timepoint [22] 398207 0
Baseline and 32 weeks (end intervention)
Secondary outcome [23] 398208 0
Quality of Life as assessed by Pain Catastrophizing Scale
Timepoint [23] 398208 0
Baseline and 32 weeks (end intervention)
Secondary outcome [24] 398209 0
Quality of Life as assessed by EuroQol-5D-5L
Timepoint [24] 398209 0
Baseline and 32 weeks (end intervention)
Secondary outcome [25] 398210 0
Quality of Life as assessed by Obesity and Weight-Loss Quality-of-Life (OWLQOL)
Timepoint [25] 398210 0
Baseline and 32 weeks (end intervention)
Secondary outcome [26] 398211 0
Quality of Life as assessed by the Weight-Related Symptoms validated questionnaire
Timepoint [26] 398211 0
Baseline and 32 weeks (end intervention)
Secondary outcome [27] 398212 0
Quality of Nutrition as assessed by a 24-hour Food Recall ASA24-Australia-2016
Timepoint [27] 398212 0
Baseline and 32 weeks (end intervention)
Secondary outcome [28] 398213 0
Falls efficacy as assessed by Modified Falls Efficacy Scale
Timepoint [28] 398213 0
Baseline and 32 weeks (end intervention)
Secondary outcome [29] 398214 0
Knee or hip pain, stiffness and function as assessed by the Western Ontario McMaster Osteoarthritis Index
Timepoint [29] 398214 0
Baseline and 32 weeks (end intervention)
Secondary outcome [30] 399103 0
Changes in Hand Grip Strength as assessed by Jamar Hand Grip Dynamometer
Timepoint [30] 399103 0
Baseline and 32 weeks (end intervention)
Secondary outcome [31] 399104 0
Changes to bone microarchitecture as assessed by High-resolution peripheral quantitative computed tomography.
Timepoint [31] 399104 0
Baseline and 32 weeks (end intervention)
Secondary outcome [32] 399167 0
Changes to bone structure as assessed by High-resolution peripheral quantitative computed tomography.
Timepoint [32] 399167 0
Baseline and 32 weeks (end intervention)
Secondary outcome [33] 399853 0
Changes in physical function as assessed by as assessed by Stair Power Climb Test
Timepoint [33] 399853 0
Baseline and 32 weeks (end intervention)

Eligibility
Key inclusion criteria
Prospective participants must be aged 50 years or older and postmenopausal (spontaneous amenorrhea for at least 12 months); community-dwelling, scheduled for any type of bariatric surgery within the next six months; have surgeon approval to commence FIT; English-speaking, able to walk across a room unaided; with access to a smartphone connected to an internet network; willing to complete an 8 month intervention and also be willing to participate should they be randomised to either intervention arm.
Minimum age
50 Years
Maximum age
No limit
Sex
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 unaided, are non-English speaking or have difficulty communicating with study personnel due to speech or hearing problems; have body weight greater than 200kg (upper weight limit for DXA); have had lower limb joint injury or surgery in past 6 months; fracture within the last 6 months; have conditions known to influence bone health; use drugs that interfere with bone metabolism; pre-existing malabsorption or protein supplement use; are planning to be away from home for 4 weeks during the intervention; and self-reported diagnosis of: progressive neurological disorders; severe knee or hip osteoarthritis that would interfere with ability to complete functional exercise and tests; cardiovascular disease; 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; 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.

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 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
Safety/efficacy
Statistical methods / analysis
For primary outcomes related to feasibility, study retention ( equal to 90%); frequency of accessing Physitrack; and completing equal to 66% of prescribed exercise and nutritional intervention will be reported. Provided parametric assumptions are met, independent-samples t-tests would be used to examine between-arm differences in pre-post change. Where assumptions are not met, non-parametric Wilcoxon ranked sum tests would be used. For all analyses, a P-value of less than 0.05 or 95% confidence interval will be considered statistically significant. All data will be analysed using SPSS Statistics Version 24 (IBM, USA).

A modified thematic framework will be used to analyse the qualitative data. NVivo computer software (version 12, QSR International Pty Ltd, Doncaster, Victoria, Australia) will be used to code, chart and map the data. Five stages of coding will be completed: i) Familiarisation; ii) Identifying a thematic framework; iii) Indexing; iv) Charting; and v) Mapping and Interpretation. An iterative process will then be used to test and retest the thematic framework.

We may additionally analyse baseline associations between body composition, physical activity and physical function using Pearson and Spearman correlations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309126 0
Government body
Name [1] 309126 0
NHMRC
Country [1] 309126 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 310075 0
University
Name [1] 310075 0
Monash University
Address [1] 310075 0
Monash University
Level 7, TRF Building, Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country [1] 310075 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308992 0
Monash Health Ethics Committee
Ethics committee address [1] 308992 0
246 Clayton Road, Clayton Victoria 3168
Ethics committee country [1] 308992 0
Australia
Date submitted for ethics approval [1] 308992 0
14/06/2021
Approval date [1] 308992 0
Ethics approval number [1] 308992 0

Summary
Brief summary
Despite its overwhelming benefits, a negative outcome of bariatric surgery is severe loss of bone and muscle mass. Postmenopausal women experience over two-fold greater bone microarchitecture deterioration than premenopausal women and men following bariatric surgery, and as such are at greatest risk for incident fractures. We have previously identified that supervised 30 minute, twice weekly functional impact training (FIT) in postmenopausal women with low bone mass resulted in significant improvements in lumbar spine and femoral neck bone mineral density (BMD) compared to control. No study has investigated the role of FIT in postmenopausal women following bariatric surgery using telehealth applications. We hypothesise that an 8-month functional and impact training (FIT) program combined with nutritional education, delivered via a mobile application, will be acceptable, safe, and well-adhered to in postmenopausal women following bariatric surgery. It is anticipated that the outcomes of the bariatric trial will inform the design of innovative future randomised controlled trials exploring this program as a potentially effective, safe, and feasible treatment strategy for maintaining musculoskeletal health after bariatric surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112582 0
A/Prof David Scott
Address 112582 0
Deakin University,
Melbourne Burwood Campus,
221 Burwood Highway, Burwood VIC 3125
Country 112582 0
Australia
Phone 112582 0
+61 3 9246 8438
Fax 112582 0
Email 112582 0
[email protected]
Contact person for public queries
Name 112583 0
A/Prof David Scott
Address 112583 0
Deakin University,
Melbourne Burwood Campus,
221 Burwood Highway, Burwood VIC 3125
Country 112583 0
Australia
Phone 112583 0
+61392468438
Fax 112583 0
Email 112583 0
[email protected]
Contact person for scientific queries
Name 112584 0
A/Prof David Scott
Address 112584 0
Deakin University,
Melbourne Burwood Campus,
221 Burwood Highway, Burwood VIC 3125
Country 112584 0
Australia
Phone 112584 0
+61392468438
Fax 112584 0
Email 112584 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.