Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001146280
Ethics application status
Approved
Date submitted
23/06/2018
Date registered
12/07/2018
Date last updated
12/07/2019
Date data sharing statement initially provided
12/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Osteogenic Exercise for Musculoskeletal and Metabolic Health during Weight Loss in Sarcopenic Obese Older Adults: A Pilot Study (OSMOSIS-P)
Scientific title
Osteogenic Exercise for Musculoskeletal and Metabolic Health during Weight Loss in Sarcopenic Obese Older Adults: A Pilot Study (OSMOSIS-P)
Secondary ID [1] 295292 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
OSMOSIS-P
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Sarcopenic Obesity 308479 0
Musculoskeletal Health 308480 0
Metabolic Health 308481 0
Condition category
Condition code
Metabolic and Endocrine 307459 307459 0 0
Diabetes
Musculoskeletal 307460 307460 0 0
Other muscular and skeletal disorders
Diet and Nutrition 307461 307461 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the 12week intervention period, all participants will follow the dietary intervention prescribed and supervised by a licensed dietician with 11 years experience in the field, Equal numbers will be randomised to either gym-based High Intensity Resistance and Impact Training (HiRIT) or home-based aerobic exercise(control) as described below.

Dietary Intervention
To determine the amount of energy in the diet that will be prescribed to each participant, habitual dietary nutrient intake will be assessed using a pre-tested 3-day food record form (two non-consecutive weekdays and one weekend) before the commencement of the study intervention. To complete the food record, study participants will list all the foods and beverages that they have consumed for the whole day, including quantities. From these data, each 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. Three day food records will be administered at baseline and 12 weeks to constantly monitor the dietary intake of the participants and to ensure compliance. Each participant will be oriented by the study dietician on how to quantify their intake using food models and measuring utensils, as well as on how to reduce food portion sizes and replacing energy-dense foods with those of lower energy density. Food records will be validated by the study investigators through one-on-one interview with the study participant at each time point. Dietary nutrient intake of subjects will be processed using FoodWorks 8 Professional for Windows (Xyris Software (Australia), Pty Ltd), which uses the latest Australian Food and Nutrient Database (AUSNUT) 2011-2013 (FSANZ, 2014). AUSNUT is a database which contains 53 nutrient values for 5740 foods and beverages. The study dietician will conduct telephone interviews every week throughout the intervention to monitor and review dietary intakes and set behavioural goals. Participants with poor dietary compliance, as demonstrated by deviations from the diet prescription during the telephone interviews, will be given a 7-day dietary plan to ensure compliance.
Whey protein isolate and vitamin D (cholecalciferol; 1000 IU/day) supplements will also be provided to ensure adequate intakes of this important nutrient for musculoskeletal health is maintained during dietary restriction. The whey protein isolate will be in powdered form that can be mixed with skim milk or water as the participant prefers. The dose will vary for each participant throughout the intervention as it will be modified based on their estimated current protein intake (reported in food records) to ensure they are meeting a protein intake of 1.0g/kg/day. Vitamin D + calcium supplement will be in capsule form that will be taken orally.

Treatment: High Intensity Resistance and Impact Training
Participants allocated to the HiRiT group in the present study will be given a structured 12week, twice weekly, 30minute, supervised, gym based HiRIT program. Each participant will be encouraged to attend each supervised session by an accredited exercise physiologist at the local gymnasium, Healthwise, at Monash Medical Centre, Clayton and will not be required to pay an entry fee to attend; gym fees will be covered by the study budget and have been negotiated at $5 per exercise session during off peak hours (midmorning and midafternoon). Each exercise session will be performed in small groups with a maximum of 8 participants and attendance will be recorded via an exercise sheet. All exercises will be individually tailored and progressive, considering initial fitness, injuries or illness. The prescribed exercise program will use pinloaded smith machine bar or an olympic bar +/weight plates unless contraindicated. Participants will perform up to 2 sets of 5 repetitions of all four exercises at 50% of 1 Repetition Maximum (RM) to serve as a warmup at each session as required. Participants will be then required to perform 5 sets of 5 repetitions, at an intensity of >80% to 85% 1 RM. Each participant will be encouraged to increase the load of the four prescribed exercises each session while maintaining the desired intensity if able. All participants will be individually prescribed four fundamental exercises (deadlift, overhead press, and back squat and modified jumping chin ups) throughout the intervention period. To ensure safe transition to HiRIT exercise, the first two weeks of the intervention will involve body weight only and low load exercise variants, with a focus on learning the movement patterns. All participants will be able to perform the four fundamental exercises of the intervention within 4 weeks. Adherence to intervention will be determined through session attendance checklists and accomplished exercise diaries which will be reviewed during weekly followup calls throughout the intervention.

Control
The control group will complete a moderate intensity, home-based aerobic exercise program. Participants will aim to progress to 150mins/week of walking/jogging at moderate intensity, based on self-perceived exertion reported on the Borg scale, and maintain this for the duration of the home-based intervention. This exercise program is modelled on the Lifestyle Interventions for Elders project and we have used it in previous studies in similar populations. Participants will be asked to complete exercise diaries to assess compliance and these will be reviewed during weekly followup calls throughout the intervention.
Intervention code [1] 301624 0
Treatment: Other
Comparator / control treatment
The control group will complete a moderate intensity (12-14 on a 20 point Borg RPE scale), home-based aerobic exercise program. Participants will aim to progress to 150mins/week of walking/jogging (in any combination, 30 mins x 5 sessions every week) at moderate intensity, based on self-perceived exertion reported on the Borg scale, and maintain this for the duration of the home-based intervention. This exercise program is modelled on the Lifestyle Interventions for Elders project and we have used it in previous studies in similar populations. Participants will be asked to complete exercise diaries to assess compliance and these will be reviewed during weekly followup calls throughout the intervention. Both treatment and control group will follow the dietary intervention prescribed by the licensed dietician.
Control group
Active

Outcomes
Primary outcome [1] 306432 0
Change in usual gait speed over a 4m course using stopwatch.
Timepoint [1] 306432 0
at baseline and after 12 weeks of intervention
Secondary outcome [1] 348524 0
change in percent body fat using dual-energy X-ray absorptiometry (DXA) scan (Hologic Discovery A, Hologic, USA),
Timepoint [1] 348524 0
at baseline and after 12 weeks of intervention
Secondary outcome [2] 348525 0
Serum samples will be analysed for changes in lipid profile (triglycerides (TG), low density lipoprotein, and total cholesterol)
Timepoint [2] 348525 0
at baseline and after 12 weeks of intervention
Secondary outcome [3] 348526 0
change in height (using a wall mounted stadiometer (Seca 213, Seca, Germany).
Timepoint [3] 348526 0
at baseline and after 12 weeks of intervention
Secondary outcome [4] 348527 0
changes in blood pressure will be measured using a digital blood pressure monitor (Welch Allyn Connex Pro BP 3400, Welch Allyn, USA).
Timepoint [4] 348527 0
at baseline and after 12 weeks
Secondary outcome [5] 348528 0
change in health related quality of life using CDC Healthy Days Questionnaire
Timepoint [5] 348528 0
at baseline and after 12 weeks of intervention
Secondary outcome [6] 348529 0
changes in physical activity levels which includes data on steps/day using Actigraph wGT3X-BT accelerometer (Actigraph, USA)
Timepoint [6] 348529 0
at baseline and after 12 weeks of intervention
Secondary outcome [7] 348715 0
Change in standing balance using stopwatch
Timepoint [7] 348715 0
at baseline and after 12 weeks of intervention
Secondary outcome [8] 348716 0
Change in semi-tandem stand using stopwatch
Timepoint [8] 348716 0
at baseline and after 12 weeks of intervention
Secondary outcome [9] 348717 0
Change in full tandem stand using stopwatch
Timepoint [9] 348717 0
at baseline and after 12 weeks of intervention
Secondary outcome [10] 348718 0
Change in stair climb power test using stopwatch
Timepoint [10] 348718 0
at baseline and after 12 weeks of intervention
Secondary outcome [11] 348719 0
change in bone mineral density using dual-energy X-ray absorptiometry (DXA) scan (Hologic Discovery A, Hologic, USA), and quantitative ultrasonography (Hologic Sahara Bone Sonometer, Hologic, USA);
Timepoint [11] 348719 0
at baseline and after 12 week of intervention
Secondary outcome [12] 348720 0
change in bone microarchitecture using Tibial Peripheral Quantitative Computed Tomography (pQCT) and High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT)
Timepoint [12] 348720 0
at baseline and after 12 week of intervention
Secondary outcome [13] 348721 0
Serum samples will be analysed for changes in glucose level
Timepoint [13] 348721 0
at baseline and after 12 weeks of intervention
Secondary outcome [14] 348722 0
Serum samples will be analysed for changes in insulin level
Timepoint [14] 348722 0
at baseline and after 12 weeks of intervention
Secondary outcome [15] 348723 0
Serum samples will be analysed for changes in high-sensitivity C-reactive protein (hs-CRP)
Timepoint [15] 348723 0
at baseline and after 12 weeks of intervention
Secondary outcome [16] 348724 0
Serum samples will be analysed for changes serum 25-hydroxyvitamin D (25OHD)
Timepoint [16] 348724 0
at baseline and after 12 weeks of intervention
Secondary outcome [17] 348725 0
Serum samples will be analysed for changes in bone markers such as serum type 1 collagen type 1 C-telopeptide (CTX) and type 1 procollagen N-terminal peptide (PINP)
Timepoint [17] 348725 0
at baseline and after 12 weeks of intervention
Secondary outcome [18] 348726 0
change in weight (using electronic scales, Seca 804, Seca, Germany)
Timepoint [18] 348726 0
at baseline and after 12 weeks of intervention
Secondary outcome [19] 348727 0
change in waist circumference (using a measuring tape (Seca 203))
Timepoint [19] 348727 0
at baseline and after 12 weeks of intervention
Secondary outcome [20] 348728 0
changes in heart rate will be measured using a digital blood pressure monitor (Welch Allyn Connex Pro BP 3400, Welch Allyn, USA).
Timepoint [20] 348728 0
at baseline and after 12 weeks of intervention
Secondary outcome [21] 348730 0
change in falls risk using Modified Falls Efficacy Scale
Timepoint [21] 348730 0
at baseline and after 12 weeks
Secondary outcome [22] 348731 0
Change in handgrip strength using Jamar hydraulic hand grip dynamometer (Lafayette Instrument Company, USA),
Timepoint [22] 348731 0
at baseline and after 12 weeks intervention
Secondary outcome [23] 349038 0
change in hip circumference (using a measuring tape (Seca 203))
Timepoint [23] 349038 0
at baseline and after 12 weeks of intervention
Secondary outcome [24] 349039 0
change in sarcopenia quality of life using Sarcopenia Quality of Life Questionnaire (SarQoL)
Timepoint [24] 349039 0
at baseline and after 12 weeks of intervention
Secondary outcome [25] 349203 0
change in lean body mass using dual-energy X-ray absorptiometry (DXA) scan (Hologic Discovery A, Hologic, USA),
Timepoint [25] 349203 0
at baseline and after 12 weeks of intervention
Secondary outcome [26] 349204 0
change in health related quality of life using EuroQol-5D-5L
Timepoint [26] 349204 0
at baseline and after 12 weeks of intervention
Secondary outcome [27] 349205 0
changes in physical activity levels which includes data on moderate and vigorous activity and sedentary time using Actigraph wGT3X-BT accelerometer (Actigraph, USA)
Timepoint [27] 349205 0
at baseline and after 12 weeks of intervention
Secondary outcome [28] 372538 0
Serum samples will be analysed for changes in gamma-glutamyl transferase (GGT), aspartate transaminase (AST), platelet count, albumin and alanine aminotransferase (ALT).

This is a composite secondary outcome.
Timepoint [28] 372538 0
at baseline and after 12 weeks of intervention

Eligibility
Key inclusion criteria
Prospective participants must be aged 60-89 years; have a body mass index (BMI) of 28 kg/m2; and a body fat percentage of greater than or equal to 30 (men) or of greater than or equal to 40 (women) determined by dual-energy X-ray absorptiometry (DXA); a Short Physical Performance Battery (SPPB) score of of less than or equal to 11 out of 12 indicating presence of a mobility limitation; willing, and has GP approval to complete a 12-week diet and exercise 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 400m in 15 minutes without use of walking aids; are non-English speaking or have difficulty communicating with study personnel due to speech or hearing problems; have moderate or severe cognitive impairment defined as a Mini-Mental State Exam (MMSE) score of of less than or equal to 18 points out of 30; report 4 weeks or more of 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 4 weeks or more 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 a joint replacement) that would interfere with ability to complete functional 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. Temporary exclusion criteria will include hip or knee replacement, spinal surgery, stroke, myocardial infarction, major heart surgery, deep vein thrombosis, or pulmonary embolus in the past 6 months.

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)
Central randomisation by phone/fax/computer

This study is a single-blind randomised controlled trial in that investigators collecting outcome measures will be blinded to exercise allocation of participants. As this trial involves exercise interventions, it is not possible to blind participants to their intervention arm allocation. Participants will be randomised to gym-based HiRIT or home-based aerobic exercise (control) using computer-generated block randomisation of numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization 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
Sample Size
It is not feasible to include falls as a primary outcome for this pilot study given that this would demand larger sample sizes and longer follow-up periods than can be supported by available funding. Therefore, change in usual gait speed over a 4m course from baseline to follow-up will be the primary outcome for the present study. Usual gait speed is recommended as a single assessment for functional outcomes including falls in older adults, and our analyses of the CHAMP cohort, suggest poor gait speed is the primary contributor to increased falls risk in sarcopenic obesity. We will recruit a total sample size of 60 subjects (equal numbers of males and females), with 30 allocated to each arm. Adjusting for a loss to follow-up of 20%, this sample size is large enough to detect a clinically meaningful 0.10m/s (0.12m/s SD) difference in usual gait speed between the HiRIT and control groups.

Statistical Analysis
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 treatment 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).

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/07/2018
Actual
27/02/2019
Date of last participant enrolment
Anticipated
23/08/2020
Actual
Date of last data collection
Anticipated
23/11/2020
Actual
Sample size
Target
60
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11224 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 23097 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 299886 0
Charities/Societies/Foundations
Name [1] 299886 0
Rebecca L. Cooper Medical Research Foundation
Country [1] 299886 0
Australia
Primary sponsor type
Individual
Name
Dr. David Scott
Address
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, Australia 3168
Country
Australia
Secondary sponsor category [1] 299241 0
Individual
Name [1] 299241 0
Prof. Peter Ebeling
Address [1] 299241 0
Department of Medicine,
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, Australia 3168.
Country [1] 299241 0
Australia
Secondary sponsor category [2] 303284 0
Individual
Name [2] 303284 0
Mavil May Cervo
Address [2] 303284 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [2] 303284 0
Australia
Secondary sponsor category [3] 303285 0
Individual
Name [3] 303285 0
Jakub Mesinovic
Address [3] 303285 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [3] 303285 0
Australia
Secondary sponsor category [4] 303286 0
Individual
Name [4] 303286 0
Paul Jansons
Address [4] 303286 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [4] 303286 0
Australia
Secondary sponsor category [5] 303287 0
Individual
Name [5] 303287 0
Anoohya Gandham
Address [5] 303287 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [5] 303287 0
Australia
Secondary sponsor category [6] 303288 0
Individual
Name [6] 303288 0
Carrie-Anne Ng
Address [6] 303288 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [6] 303288 0
Australia
Secondary sponsor category [7] 303289 0
Individual
Name [7] 303289 0
Dr. Michael Braude
Address [7] 303289 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [7] 303289 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300755 0
Monash Health-Human Research Ethics Committee
Ethics committee address [1] 300755 0
Ethics committee country [1] 300755 0
Australia
Date submitted for ethics approval [1] 300755 0
16/05/2018
Approval date [1] 300755 0
01/08/2018
Ethics approval number [1] 300755 0
HREC/18/MonH/399

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

Contacts
Principal investigator
Name 84706 0
Dr David Scott
Address 84706 0
Department of Medicine, School of Clinical Sciences
Monash University
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, Australia 3168.
Country 84706 0
Australia
Phone 84706 0
+61 3 8572 2397
Fax 84706 0
Email 84706 0
david.scott@monash.edu
Contact person for public queries
Name 84707 0
David Scott
Address 84707 0
Department of Medicine, School of Clinical Sciences
Monash University
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, Australia 3168.
Country 84707 0
Australia
Phone 84707 0
+61 3 8572 2397
Fax 84707 0
Email 84707 0
david.scott@monash.edu
Contact person for scientific queries
Name 84708 0
David Scott
Address 84708 0
Department of Medicine, School of Clinical Sciences
Monash University
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, Australia 3168.
Country 84708 0
Australia
Phone 84708 0
+61 3 8572 2397
Fax 84708 0
Email 84708 0
david.scott@monash.edu

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 participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months following main results publication, with no end date determined.
Available to whom?
De-identified participant data will be provided on case-by-case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
Any analysis approved by the Principal Investigator after submission of an analysis plan by the applicant.
How or where can data be obtained?
After approval by the Principal Investigator, the data will be transferred via a secure data sharing service.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2855Study protocol  david.scott@monash.edu
2856Ethical approval  david.scott@monash.edu



Results publications and other study-related documents

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