Evaluating mobility and strength training with and without protein supplements in pre-frail/frail older adults with low protein intake

INTERVENTION: 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 adults with low protein intake. Participants will be randomized (1:1) to mobility and strength training with or without protein supplements. Participants will be identified by clinical staff working in NHS rehabilitation services such as physiotherapy and falls clinics at three to five NHS sites in England and with the patient’s permission will be referred to site research staff for consent, screening and eligibility assessment. We will also identify potential participants from an existing cohort study (Oxford, Pain, Activity and Lifestyle (OPAL) cohort study). Potential participants will be identified from their most recent OPAL questionnaire and invited by the OPAL study team to undergo screening for the trial. Interested participants will be referred to site research staff for screening and eligibility assessment. OPAL participants have given consent to be contacted about the opportunity to take part in other studies. We will ensure that we clearly identify the recruitment path for each MMoST participant to enable us to understand the numbers of potential participants expected to be identified from the OPAL cohort and those from normal NHS referral routes should we move forward to a larger study. Consent, screening, eligibility assessments and randomization will be undertaken by site research staff. Following initial screening via telephone, potentially eligible participants will attend an in‐person eligibility assessment. As part of the eligibility assessment, participants will be asked to com CONDITION: Pre‐frail/frail older adults with low protein intake ; Not Applicable PRIMARY OUTCOME: ; 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.; 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 SECONDARY OUTCOME: ; 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), inde Xof 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);