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

Phase 3

Recruiting

• Conditions: Frailty; mild cognitive impairment; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; musculoskeletal; Diet and Nutrition - Other diet and nutrition disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616000521426
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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];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]

Secondary Outcome Measures

Name	Time	Method
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];nutritional intake assessed using multipass 24 hr diet recall[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];Quality of life assessed using the SF 36 questionnaire[Baseline, and 12 and 24 weeks after randomisation to one of the two study arms];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]