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Trial registered on ANZCTR


Registration number
ACTRN12616000521426
Ethics application status
Approved
Date submitted
14/04/2016
Date registered
21/04/2016
Date last updated
9/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The EXPRESS pilot study: EXercise and PRotein Supplementation Supporting Autonomy in Prefrail & Frail Community Residing adults aged 65 years or older
Scientific title
The EXPRESS pilot study: EXercise and PRotein Supplementation Supporting Autonomy in Prefrail & Frail Community Residing adults aged 65 years or older
Secondary ID [1] 289033 0
None
Universal Trial Number (UTN)
U1111-1182-0484
Trial acronym
EXPRESS (EXercise and PRotein Supplementation Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 298398 0
mild cognitive impairment 298399 0
musculoskeletal 298447 0
Condition category
Condition code
Diet and Nutrition 298497 298497 0 0
Other diet and nutrition disorders
Musculoskeletal 298546 298546 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298547 298547 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study is a randomised, parallel, control pilot study conducted over 6 months with participants being assessed at baseline, at 3 months and at 6 months.

Participants will be randomly assigned to one of 2 treatments:
1) twice daily 20 g rice protein supplements combined with a multi-component exercise program (n=60); and
2) twice daily 20 g whey protein supplements combined with a multi-component exercise program (n=60).

The nutrition prescription will be given by a qualified dietitian from CSIRO Food and Nutrition Unit. All protein supplements will be provided as a powder in individual 26 g sachets to provide 20 g of protein when reconstituted in ~150 ml of water. All drinks will be isocaloric and isonitrogeneous and of comparable taste, texture and aroma.

The exercise program, which will commence at the same time as the protein supplementation, consists of a combination of aerobic, resistance, balance and flexibility exercises that will be performed once per week as a central gym-based group session and also three to five times a week at home. The goal will be for each participants to achieve ~150 min of exercise per week. The one centre-based session and at least 2 of the home-based sessions will consist of 10 min of strength exercises, 10 min of balance exercises and 10 min of flexibility exercises.

The exercise program will be delivered by at least two qualified exercise physiologists and physiotherapist who is trained in geriatric medicine. The exercise prescription is based on the LIFE study, a physical activity intervention for community-dwelling frail older people conducted in the USA [Cesari M, Vellas B, Hsu FC, Newman AB, Doss H, King AC, et al. A. J Gerontol A Biol Sci Med Sci. 2015 Feb;70(2):216-22. ]. The Exercise physiologist will titrate each participants exercise program every 6 weeks to ensure they continue to improve their physical capacity over the 6 month study. Resistant tubing, and/or wrist and/or ankle weights will be used to increase resistance for the strength exercises.

Examples of the types of exercises that participants will be asked to do include: 1) WARM UP- shoulder/wrist, ankle circles; 2) STRENGTH - knee extension, sit to stand using arms, hip abduction and hip adduction (standing and/or sitting), bicep curl, seated row, heel/toe raise, standing march; 3) Flexibility - arm lift, touching toes.

Strength exercises will be conducted at an intensity of 15-16 RPE on the Borg Scale and walking will be conducted at an intensity of 12-14 RPE on the Borg Scale . The Borg Scale allows a rating of the self-perceived exertion and can be used to monitor and control the intensity of exercise interventions [Pritchett RC, Del Pozzi AT, Katica CP, Pritchett KL. Med Sci Sport Exer. 2011 May;43(5):86]. Instructions on how to perform the home-based exercises and record the number and intensity of specific exercise will be recorded while at home using a compliance dairy. Compliance diaries will be handed-out to participants at each assessment visit with instruction on how to complete. Compliance with the required intake of the supplements and exercise prescription will be checked by the research dietitian and exercise physiologist, respectively, on a weekly basis initially (during first two weeks) and every 2 weeks if no problems are evident. If a deviation greater than 10% of the intake recommendations is detected (for either of the supplements) the dietician will interview the participant to identify strategies that could help rectify any reduced compliance and facilitate compliance in case of any difficulty. For the exercise prescription, if a deviation greater than 10% of the required sessions is detected, the exercise physiologist or an supporting team member will interview the participant to identify strategies that could help rectify any reduced compliance and facilitate compliance in case of any difficulty.
Intervention code [1] 294480 0
Lifestyle
Comparator / control treatment
Two sachets containing 20 g of rice protein will be consumed each day for 6 months in combination with the multi-component exercise program.

The only difference with the comparator is that the protein supplement is a lower quality rice protein rather than the higher quality whey protein used in the study intervention.
Control group
Active

Outcomes
Primary outcome [1] 297987 0
gait speed using 4 m walk test - 2 repetitions
Timepoint [1] 297987 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Primary outcome [2] 297990 0
physical performance using the Standard Physical Performance battery and Timed Up and Go test
Timepoint [2] 297990 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Primary outcome [3] 297991 0
grip strength using electronic hand-held dyanomanometer and dominant hand
Timepoint [3] 297991 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Secondary outcome [1] 322847 0
Frailty measured using the 5-item Frail Screen questionnaire
Timepoint [1] 322847 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Secondary outcome [2] 322848 0
muscle mass assessed using single frequency bioelectrical impedance
Timepoint [2] 322848 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Secondary outcome [3] 322849 0
nutritional intake assessed using multipass 24 hr diet recall
Timepoint [3] 322849 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Secondary outcome [4] 322850 0
physical activity will be assessed over a 7 day period using accelerometry
Timepoint [4] 322850 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Secondary outcome [5] 322851 0
Quality of life assessed using the SF 36 questionnaire
Timepoint [5] 322851 0
Baseline, and 12 and 24 weeks after randomisation to one of the two study arms
Secondary outcome [6] 323060 0
Adverse effects will be recorded in a diary. Potential adverse events may include dizziness, chest pain or nausea during or after exercise, or nausea, reduced appetite, and mild gastrointestinal symptoms (e.g. bloating, gas, diarrhoea).
Timepoint [6] 323060 0
Recorded continuously and reported at weeks 12 and 24

Eligibility
Key inclusion criteria
- adults aged 65 years and older
- able to converse in English
- living in the community
- have a FRAIL Screen score equal to, or greater than, 1
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Dementia (i.e. score 5 or less) as per the Rapid Cognitive Screen (Malmstrom, Voss et al. 2015),
- Severe renal impairment (eGFR <30 mmol/L)
- Unable to comply with the exercise or nutrition study protocol.

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)
allocation concealment will be achieved by having the study statistician who is not involved in the assessments and who is“off site” being the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The data will be analyzed on an intention-to-treat basis.

Participants will be characterized according to age, gender, frailty score, Katz ADL, Lawton iADL, Charlson’s co-morbidity, BIA (low muscle mass or not), MNA-SF, MMSE, GDS-15, Polypharmacy (>/=5).

For each study outcome, the change from baseline after 12 weeks, and the change from baseline after 24 weeks, will be compared between the two treatment arms.
These analyses will be estimated in an ANCOVA model with change from baseline as outcome, and the baseline values for frailty, age, gender and any other factors that differ at baseline as covariates, and treatment as fixed effects. The resulting treatment effect will be reported as least square mean and 95% confidence interval for the main outcomes of gait speed, leg press and grip strength.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5617 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 5618 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 13063 0
5011 - Woodville
Recruitment postcode(s) [2] 13064 0
5085 - Northgate

Funding & Sponsors
Funding source category [1] 293361 0
Other Collaborative groups
Name [1] 293361 0
Northern Communities Health Alliance Fund
Address [1] 293361 0
Northern Community Health Foundation Incorporated, 185 Cooper Street, Epping, Vic 3076
Country [1] 293361 0
Australia
Funding source category [2] 293362 0
University
Name [2] 293362 0
University of Adelaide
Address [2] 293362 0
Discipline of Medicine, The University of Adelaide, and Clinical Director of the Aged & Extended Care Services at the Queen Elizabeth Hospital
28 Woodville Road, Woodville South, SA 5011
Country [2] 293362 0
Australia
Funding source category [3] 293363 0
Government body
Name [3] 293363 0
Food and Nutrition, Commonwealth Science and Industrial Research Organisation
Address [3] 293363 0
Level 7, SAHMRI, North Terrace, Adelaide PO Box 10097, Adelaide BC, South Australia, 5000, Australia
Country [3] 293363 0
Australia
Funding source category [4] 293364 0
Other Collaborative groups
Name [4] 293364 0
Centre for Physical Activity in Ageing
Address [4] 293364 0
Hampstead Rehabilitation Centre
207-255 Hampstead Road
Northfield
South Australia, 5085
Country [4] 293364 0
Australia
Funding source category [5] 293365 0
Other Collaborative groups
Name [5] 293365 0
ACH
Address [5] 293365 0
ACH Group's Corporate Office
22 Henley Beach Road, Mile End, South Australia, 5031
Country [5] 293365 0
Australia
Funding source category [6] 293368 0
Other Collaborative groups
Name [6] 293368 0
BMP Health Management Consultants
Address [6] 293368 0
GP PLus Clinic, Oakden, Adelaide & Department of General Practice at The Queen Elizabeth Hospital, Adelaide
1 Gilles Cres, Hillcrest, South Australia, 5086
Country [6] 293368 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Discipline of Medicine, The University of Adelaide, and Clinical Director of the Aged & Extended Care Services at the Queen Elizabeth Hospital
28 Woodville Road, Woodville South, SA 5011
Country
Australia
Secondary sponsor category [1] 292187 0
Government body
Name [1] 292187 0
Food and Nutrition, Commonwealth Science and Industrial Resaerch Organisation
Address [1] 292187 0
Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide PO Box 10097, Adelaide BC, South Australia, 5000, Australia
Country [1] 292187 0
Australia
Secondary sponsor category [2] 292188 0
Other Collaborative groups
Name [2] 292188 0
ACH Group
Address [2] 292188 0
ACH Group's Corporate Office
22 Henley Beach Road, Mile End, South Australia 5031
Country [2] 292188 0
Australia
Secondary sponsor category [3] 292190 0
Hospital
Name [3] 292190 0
Centre for Physical Activity in Ageing
Address [3] 292190 0
Centre for Physical Activity in Ageing
Hampstead Rehabilitation Centre
207-255 Hampstead Road
Northfield
South Australia, 5085
Country [3] 292190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294829 0
University of Adelaide
Ethics committee address [1] 294829 0
Level 4, Rundle Mall Plaza
50 Rundle Mall
Adelaide SA 5000
Ethics committee country [1] 294829 0
Australia
Date submitted for ethics approval [1] 294829 0
05/10/2015
Approval date [1] 294829 0
12/04/2016
Ethics approval number [1] 294829 0
H-2015-224
Ethics committee name [2] 294830 0
The Queen Elizabeth Hospital Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [2] 294830 0
The Queen Elizabeth Hospital
Basil Hetzel Institute DX465101
28 Woodville Road
Woodville South SA 5011
Ethics committee country [2] 294830 0
Australia
Date submitted for ethics approval [2] 294830 0
08/02/2016
Approval date [2] 294830 0
30/03/2016
Ethics approval number [2] 294830 0
HREC/16/TQEH/10
Ethics committee name [3] 294831 0
CSIRO HREC
Ethics committee address [3] 294831 0
Ecosciences Precinct, Dutton Park QLD 4102
GPO BOX 2583, Brisbane, QLD 4001 Australia
Ethics committee country [3] 294831 0
Date submitted for ethics approval [3] 294831 0
22/03/2016
Approval date [3] 294831 0
29/03/2016
Ethics approval number [3] 294831 0
HREC 10/2016

Summary
Brief summary
This proposed research will examine the feasibility of the FRAIL Screen in general practice as a screening tool for frailty and determine the impact of a high- as compared to low-quality protein supplement in combination with a centre- and home-based exercise intervention on muscle strength, physical function parameter and quality of life in frail older people who live in the community.

Aims:
1. To examine, the feasibility of recruiting 120 community-dwelling older people, aged 65 years and older who have screened frail (>1) using the FRAIL SCREEN tool to a 6 months intervention study involving nutrition and exercise;
2. To determine the effects, over a period of 6 months, of exercise in combination with either (i) high-quality whey protein supplements or (ii) lower-quality rice protein supplement, on the primary outcomes of gait speed, leg press and grip strength, and physical performance, and other secondary outcomes including frailty, muscle mass, nutritional intake, physical activity, and quality of life.

Hypotheses:
1. It is feasible to recruit 120 community dwelling frail older people using the FRAIL SCREEN tool through the ACH referral system and multiple proposed referral strategies.
2. It is feasible for participants to participate in the proposed nutritional and exercise supplementation program for a period of 6 months.
3. The higher-quality whey protein supplement combined with a pragmatic exercise program will result in greater improvement of gait speed and grip strength, physical performance and quality of life, and the other secondary outcomes at 3 months and 6 months than a lower quality rice protein combined with pragmatic exercise program, in older people who are frail or at-risk of frailty as determined by the FRAIL Screen.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65146 0
Prof Renuka Visvanathan
Address 65146 0
Discipline of Medicine, The University of Adelaide, and the Clinical Director of the Aged & Extended Care Services at the Queen Elizabeth Hospital
28 Woodville Road, Woodville South, SA 5011
Country 65146 0
Australia
Phone 65146 0
+61 8 8222 6000
Fax 65146 0
Email 65146 0
renuka.visvanathan@adelaide.edu.au
Contact person for public queries
Name 65147 0
Ms Agathe Daria Jadczak
Address 65147 0
Discipline of Medicine, The University of Adelaide, located at the Basil Hetzel Building,
28 Woodville Road, Woodville South, SA 5011
Country 65147 0
Australia
Phone 65147 0
+61 8 81334012
Fax 65147 0
Email 65147 0
agathedaria.jadczak@adelaide.edu.au
Contact person for scientific queries
Name 65148 0
Prof Natalie Luscombe-Marsh
Address 65148 0
CSIRO food and Nutrition, Level 7, SAHMRI, North Terrace, Adelaide PO Box 10097, Adelaide BC, South Australia, 5000, Australia
Country 65148 0
Australia
Phone 65148 0
+61 8 8305 0605
Fax 65148 0
Email 65148 0
Natalie.Luscombe-Marsh@csiro.au

No information has been provided regarding IPD availability
Summary results
No Results