Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000192280
Ethics application status
Approved
Date submitted
25/01/2018
Date registered
7/02/2018
Date last updated
3/11/2020
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Exercise for the Prevention of Falls in Older Adults with Sarcopenic Obesity Pilot Study (ESPRESSO-P).
Scientific title
The Exercise for the Prevention of Falls in Older Adults with Sarcopenic Obesity Pilot Study
Secondary ID [1] 293862 0
Nil
Universal Trial Number (UTN)
Trial acronym
ESPRESSO-P Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenic Obesity 306325 0
Falls Risk 306440 0
Condition category
Condition code
Musculoskeletal 305410 305410 0 0
Other muscular and skeletal disorders
Diet and Nutrition 305515 305515 0 0
Obesity
Injuries and Accidents 305516 305516 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to an exercise program or lifestyle education (control).

Exercise group participants will be prescribed a 24-week, individual home-based intervention modelled on the successful “Lifestyle integrated Functional Exercise (LiFE)” falls prevention program. LiFE training focuses on instituting new habitual behaviours within selected situational contexts that serve as prompts for action. Rather than a prescribed set of exercises conducted several times a week, in the LiFE approach, movements targeting improved balance and/or strength are embedded within everyday activities, so that they can be done multiple times during the day. For example, a prescribed activity targeting the balance strategy of “reducing base of support” includes a tandem stand while working at a kitchen bench, which can be progressed to working while standing on one leg. The LiFE program will be modified for the present study to incorporate a moderate-intensity ambulatory exercise program and moderate impact, weight-bearing exercises, which have demonstrated effectiveness in improving functional capacity and femoral neck and lumbar spine BMD, respectively.

Weight-bearing impact exercises will be completed daily for 24 weeks. Exercises will take 10-15 minutes to complete, and training intensity will be progressively increased.

The moderate-intensity ambulatory exercise program will have weekly targets that can be completed over 2-4 days during the week, depending on participant's initial level of fitness. This will be progressively increased over 24 weeks.

The modified LiFE program (ESPRESSO-P) will be taught in seven home visits by a trainer (member of study staff with experience in delivering exercise programs) in the first 12-week period of the intervention and fortnightly follow-up phone calls during the second 12-week period. Positive reinforcement from the trainer, participant goal-setting and self-monitoring, and other strategies are used to enhance self-efficacy and adherence in the later twelve weeks. All exercises will be individually-tailored, considering initial fitness, injuries or illness.

Participants will also be asked to complete the physical activity diary during each week of the training phase to determine adherence to the home-based exercise protocol.
Intervention code [1] 300124 0
Treatment: Other
Intervention code [2] 300206 0
Lifestyle
Intervention code [3] 300207 0
Prevention
Comparator / control treatment
The control group will receive usual care in the form of lifestyle education at baseline only. A sham exercise intervention is not preferred given that it is challenging to provide matching sham exercise for this multi-component intervention (particularly for weight-bearing impact exercise), and also given sham did not produce different falls outcomes to control in the LiFE trial. Participants assigned to control will receive general literature on exercise for muscle strength and bone health based on current NHMRC, Exercise and Sport Science Australia, and Osteoporosis Australia guidelines. There is no evidence that providing health information in this manner elicits ongoing behaviour change.
Control group
Active

Outcomes
Primary outcome [1] 304546 0
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 of the present study. Usual gait speed is recommended as a single assessment for functional outcomes including falls in older adults, and our previous publications suggest that poor gait speed is the primary contributor to increased falls risk in sarcopenic obesity. We will recruit a total sample size of 56 subjects (equal numbers of males and females), with 28 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 multi-component exercise and control groups.
Timepoint [1] 304546 0
Gait speed will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [1] 342339 0
Change in hip Bone Mineral Density (BMD) assessed using dual-energy X-ray absorptiometry (DXA).
Timepoint [1] 342339 0
Bone outcomes will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [2] 342675 0
Change in lumbar spine Bone Mineral Density (BMD) assessed using dual-energy X-ray absorptiometry (DXA).
Timepoint [2] 342675 0
Bone outcomes will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [3] 342676 0
Change in body composition assessed using dual-energy X-ray absorptiometry (DXA).
Timepoint [3] 342676 0
Body composition will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [4] 342678 0
Change in physical performance assessed using a short physical performance battery (SPPB).
Timepoint [4] 342678 0
Physical performance outcomes will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [5] 342679 0
Changes in upper-limb strength will be assessed using a handgrip dynamometer.
Timepoint [5] 342679 0
Strength outcomes will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [6] 342680 0
Changes in lower-limb strength will be assessed using a baseline cable tensiometer.
Timepoint [6] 342680 0
Strength outcomes will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [7] 342681 0
Change in tibial bone microarchitecture will be assessed using High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT).
Timepoint [7] 342681 0
Bone outcomes will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.
Secondary outcome [8] 342682 0
Change in radial bone geometry will be assessed using peripheral Quantitative Computed Tomography (pQCT).
Timepoint [8] 342682 0
Bone outcomes will be measured one week prior to the commencement of the intervention and one week after the completion of the intervention.

Control groups will be tested on the day they receive lifestyle education and 24 weeks after this baseline meeting.

Eligibility
Key inclusion criteria
Prospective participants must be aged 60 years or older; have a body fat percentage more than or equal to 30 (men) or more than or equal to 40 (women); a Short Physical Performance Battery (SPPB) score less than or equal to 11 out of 12; willing, and has GP approval to complete a 24-week exercise intervention; and also be willing to participate should they be randomised to either intervention arm.
Minimum age
60 Years
Maximum age
No limit
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 less than or equal to 18 points out of 30; report consuming more than 14 alcoholic drinks per week; report more than or equal to 4 weeks self-reported participation in a supervised exercise program targeted at weight loss or strength gains in the past six months; are planning to be away from home for more 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 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; 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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study is a single-blind randomised controlled trial. Eligible participants will be randomised to a multi-component exercise program (ESPRESSO-P) or lifestyle education (control) by an independent statistician using computer-generated randomisation of numbers. As this trial involves an exercise intervention, it is not possible to blind participants to their intervention arm allocation. However, research staff responsible for outcome assessments will be blinded to randomisation of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation of numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / 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 ESPRESSO-P 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).

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
12/02/2018
Actual
29/05/2018
Date of last participant enrolment
Anticipated
20/12/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9869 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 18658 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 298482 0
Charities/Societies/Foundations
Name [1] 298482 0
American Society of Bone and Mineral Research
Country [1] 298482 0
United States of America
Primary sponsor type
Individual
Name
Dr. David Scott
Address
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country
Australia
Secondary sponsor category [1] 297622 0
Individual
Name [1] 297622 0
Professor Peter Ebeling
Address [1] 297622 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [1] 297622 0
Australia
Secondary sponsor category [2] 297645 0
Individual
Name [2] 297645 0
Mr. Jakub Mesinovic
Address [2] 297645 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [2] 297645 0
Australia
Secondary sponsor category [3] 297646 0
Individual
Name [3] 297646 0
Mr. Lachlan McMillan
Address [3] 297646 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country [3] 297646 0
Australia
Secondary sponsor category [4] 303180 0
Individual
Name [4] 303180 0
Ms Carrie-Anne Ng
Address [4] 303180 0
Level 5, Block E, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168.
Country [4] 303180 0
Australia
Secondary sponsor category [5] 303181 0
Individual
Name [5] 303181 0
Ms. Anoohya Gandham
Address [5] 303181 0
Level 5, Block E, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168.
Country [5] 303181 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299469 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 299469 0
Ethics committee country [1] 299469 0
Australia
Date submitted for ethics approval [1] 299469 0
16/10/2017
Approval date [1] 299469 0
18/12/2017
Ethics approval number [1] 299469 0
HREC/17/MonH/613

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

Contacts
Principal investigator
Name 80510 0
Dr David Scott
Address 80510 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country 80510 0
Australia
Phone 80510 0
+61 3 8572 2397
Fax 80510 0
Email 80510 0
[email protected]
Contact person for public queries
Name 80511 0
David Scott
Address 80511 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country 80511 0
Australia
Phone 80511 0
+61 3 8572 2397
Fax 80511 0
Email 80511 0
[email protected]
Contact person for scientific queries
Name 80512 0
David Scott
Address 80512 0
Level 5, Block E,
Monash Medical Centre,
246 Clayton Road, Clayton,
Victoria, 3168.
Country 80512 0
Australia
Phone 80512 0
+61 3 8572 2397
Fax 80512 0
Email 80512 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 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
2606Study protocol  [email protected]
2607Ethical approval  [email protected]



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.