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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]

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

mild cognitive impairment

musculoskeletal

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

gait speed using 4 m walk test - 2 repetitions

Timepoint [1]