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

Not Applicable

Completed

• Conditions: Pre-frail/frail older adults with low protein intake; Not Applicable

• Registration Number: ISRCTN30405954
• Lead Sponsor: niversity of Oxford

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39139274/ (added 14/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Study Completion: 2024-07-31
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility will be assessed taking into account the following and using pre-defined stop/go criteria:<br>1. Recruitment rates, recorded as the number of participants recruited within 6 months.<br>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.<br>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. <br>4. Study retention at 8 months follow up, assessed by percentage of participants lost to follow up at 8 months, in either study arm.