The EXPRESS pilot study: EXercise and PRotein Supplementation Supporting Autonomy in Prefrail & Frail Community Residing adults aged 65 years or older

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000521426
• Date of registration: 21/04/2016
• Prospective Registration: Yes
• Primary sponsor: University of Adelaide
• 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
• Date of first enrolment: 09/08/2016
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616000521426.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: Ms Agathe Daria Jadczak

• Name: Prof Natalie Luscombe-Marsh

Key inclusion & exclusion criteria

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
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.

Age minimum: 65 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Frailty;mild cognitive impairment;musculoskeletal;
Frailty
mild cognitive impairment
musculoskeletal

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Diet and Nutrition - Other diet and nutrition disorders

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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 ph

Primary Outcome(s)

grip strength using electronic hand-held dyanomanometer and dominant hand[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

gait speed using 4 m walk test - 2 repetitions[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

physical performance using the Standard Physical Performance battery and Timed Up and Go test[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

Secondary Outcome(s)

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). [Recorded continuously and reported at weeks 12 and 24]

Frailty measured using the 5-item Frail Screen questionnaire[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

muscle mass assessed using single frequency bioelectrical impedance[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

Quality of life assessed using the SF 36 questionnaire[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

physical activity will be assessed over a 7 day period using accelerometry[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

nutritional intake assessed using multipass 24 hr diet recall[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms]

Secondary ID(s)

None

Source(s) of Monetary Support

Food and Nutrition, Commonwealth Science and Industrial Research Organisation

Northern Communities Health Alliance Fund

BMP Health Management Consultants

University of Adelaide

ACH

Centre for Physical Activity in Ageing

Secondary Sponsor(s)

ACH Group

Centre for Physical Activity in Ageing

Food and Nutrition, Commonwealth Science and Industrial Resaerch Organisation

Ethics review

Status: Approved
Approval date:
Contact:

CSIRO HREC

Status: Approved
Approval date:
Contact:

The Queen Elizabeth Hospital Human Research Ethics Committee (TQEH/LMH/MH)

Status: Approved
Approval date:
Contact:

University of Adelaide