Pre-frail/frail older adults with low protein intake Other
Conditions
Interventions
A multicentre, parallel, two-group, randomized controlled feasibility trial conducted in NHS community and secondary care trusts. Participants will be frail and pre-frail community dwelling older adul
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 65 years and older 2. Frail (at least three criteria) or pre-frail (one or two criteria) as defined by the Fried Frailty criteria and must include slow walking speed (or difficulty walking). 3. Low protein intake (<1 g protein/kg body weight/day) measured by the average of two 24-hour dietary recall assessments. 4. Willing and able to provide informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Dementia or cognitive impairment (defined as an Abbreviated Mental Test score of 6 or less) 2. Inability to walk 3 m without assistance (walking aid permitted) 3. Unable to follow verbal instructions which would make participation in the exercise group impractical including severe hearing impairment not corrected by a hearing aid or inability to follow simple safety instructions (e.g. English comprehension) 4. Living in a residential care or nursing home 5. Pre-existing diagnosis of: 5.1. Stroke in the last 6 months 5.2. Parkinson’s Disease 5.3. Acute, unstable physical illness that would make participation in the exercise programme unsafe 5.4. Dysphagia or swallowing problems that requires a modified diet 5.5. Type 1 diabetes or Type 2 diabetes on insulin 5.6. Severe kidney disease (stage 4 or 5) 6. Already taking protein supplements 7. Known allergies to ingredients of protein supplement (milk, soya) or lactose intolerant 8. Poor kidney function defined by an Estimated Glomerular Filtration Rate (eGFR) of <30 (blood test) 9. High risk of developing refeeding problems based on NICE guidance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility will be assessed taking into account the following and using pre-defined stop/go criteria: 1. Recruitment rates, recorded as the number of participants recruited within 6 months. 2. Intervention fidelity, recorded as the percentage of participants that undergo their individual assessment and are allocated to their group sessions, the percentage of key criteria are met during observed sessions, and percentage of participants that receive the protein supplements via home delivery as intended. 3. Intervention adherence, assessed by the number of exercise sessions attended by participants, and percentage of days over the intervention period that participants report taking their protein supplement. 4. Study retention at 8 months follow up, assessed by percentage of participants lost to follow up at 8 months, in either study arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary aim of the study is to trial the data collection procedures to be used in a main trial. We will collect the following data at 0 and 8 months unless indicated otherwise:: 1. Date of birth, sex, ethnicity, relationship status, height and weight (body mass index), index of deprivation (from postcode), type of housing, work status, education, requires a carer or not (and type of carer – paid/unpaid), household income measured using self-reported questions (baseline only) 2. Physical capacity measured using Short Physical Performance Battery (SPPB) (proposed primary outcome) 3. Mobility measured using 6-minute Walk Test 4. Hand grip strength measured using a hand held dynamometer 5. Quadriceps strength measured using a hand held dynamometer 6. Sarcopenia measured using SARC-F Questionnaire 7. Frailty measured using Tilburg Frailty Indicator 8. Frailty measured using Clinical Frailty Scale Health Questionnaire 9. Frailty measured using Estimate of the Fried Frailty Index 10. Falls measured using Prevention of Falls Network Europe (ProFANE) self-report of falls and fall related injuries 11. Pain measured using Nordic pain questionnaire 12. Self-reported health conditions taken from the Clinical Frailty Scale 13. Assessment of daily dietary protein intake (myfood24.org) 14. Blood test to evaluate Estimated Glomerular Filtration Rate (eGFR) 15. Health related quality of life measured using EQ-5D-5L 16. Health and social care resource use measured using the Client Service Receipt Inventory (8 months only) | — |
Countries
England, United Kingdom
Outcome results
None listed