Frail2Fit Study: Online Nutrition and Exercise Support for Older Adults With Frailty

NCT05384730 | Completed Results DMC

• 1 other identifier: RHM MED1860 - Frail2Fit
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Frail2Fit will explore the feasibility of training volunteers to deliver online nutrition, exercise, and behaviour change (supported self-management) to improve the health of older people after discharge from hospital. The study also aims to explore if the supported self-management is acceptable to older people, their family members and/or carers, and the volunteers. Between 30-60% of older people in hospital lose muscle strength and function (deconditioning) and around 14% of older adults in hospital are frail. Reduced muscle function and frailty increase risk of poor health outcomes, including reduced quality of life, increased risk of hospital readmission and increased risk of mortality. Therefore, intervening to prevent functional decline is a high-priority patient-centred outcome. Current evidence suggest that physical activity (PA) and nutrition interventions are key to maintaining independence and improving frailty status. In response to the COVID-19 restrictions, healthcare and rehabilitation have increasingly turned to virtual modes of delivery, such as telehealth methods. The increasing use of technology in the daily lives of many allows PA and nutrition interventions to be delivered online. For instance, the investigators have developed and evaluated a programme using online clinics to successfully support over 600 cancer patients living at home to stay active and eat well with provision of emotional support (SafeFit study). With many older people now using the internet for social connection, the team have an opportunity to investigate whether a similar model can improve the health of older people. This study aims to explore the feasibility and acceptability of implementing volunteer-led online exercise and nutrition support to frail older people discharged from hospital. The investigators aim to develop and evaluate a training programme for volunteers, determine the acceptability of the intervention through qualitative methods and identify facilitators and barriers to its implementation. The investigators will also explore the impact of the intervention on health outcomes for older people to inform future trial.

Conditions

Frailty; Malnutrition; Sedentary Behavior

Outcome Measures

Primary Outcomes (4)

• Volunteers Trained

  The number of volunteers recruited to the study and trained.

  6 months

• Volunteer Retention

  The number of volunteers retained at the end of the study

  6 months

• Adherence - Online

  The percentage of online sessions completed

  post-intervention = 3-months

• Adherence - Telephone Support

  The percentage of telephone sessions completed

  post-intervention= 3-months

Secondary Outcomes (8)

• Device-based Physical Activity Levels

  Baseline, post-intervention (3-months) and follow-up (6-months)

• Functional Ability

  Baseline, post-intervention (3-months) and follow-up (6-months)

• Appetite

  Baseline, Post-intervention (3-month) and follow-up (6-month)

• Well-being

  Baseline, Post-intervention (3-month) and follow-up (6-month)

• Depression and Anxiety

  Baseline, post-intervention (3-month) and follow-up (6-month)

Study Arms (1)

Intervention Arm

EXPERIMENTAL

This group will receive the weekly group exercise and nutrition support which will be delivered online by trained volunteers. The duration of the intervention is 12 weeks.

Other: Group nutrition and exercise support

Interventions

Group nutrition and exercise support OTHER

Weekly group nutrition and exercise support delivered online through trained volunteers

Intervention Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients:
• Older adults age 65 years and above
• Able to provide written consent
• Discharged from UHS
• Identified as frail (Clinical Frailty Scale ≥5)
• Able to walk at least a few steps upon hospital discharge
• Able to communicate fluently enough in English
• Volunteers:
• Established volunteers at UHS patient support hub
• Age 16 years and above
• Completed the generic volunteer clearance and training at UHS
• Able to provide written informed consent
• Able to communicate fluently enough in English

You may not qualify if:

• Patients:
• Older adults who are not able to safely complete the exercises included in the intervention
• Patients who are discharged to rehabilitation units, or care homes
• Patients receiving end of life care
• Volunteers:
• \- Volunteers who are unable to safely complete the exercises included in the intervention will be excluded from the study

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Bournemouth University: collaborator
• University of Southampton: collaborator

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (3)

• Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.

  PMID: 34446487 BACKGROUND

• Lim SER, Meredith S, Agnew S, Clift E, Ibrahim K, Roberts H. Evaluating the feasibility and acceptability of virtual group exercise for older adults delivered by trained volunteers: the ImPACt study protocol. BMJ Open. 2022 Feb 1;12(2):e052631. doi: 10.1136/bmjopen-2021-052631.

  PMID: 35105576 BACKGROUND

• Meredith SJ, Roberts H, Grocott MPW, Jack S, Murphy J, Varkonyi-Sepp J, Bates A, Lim SER. Frail2Fit study protocol: a feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to improve functional outcomes in older adults with frailty after discharge from hospital. BMJ Open. 2023 Mar 16;13(3):e069533. doi: 10.1136/bmjopen-2022-069533.

  PMID: 36927597 BACKGROUND

MeSH Terms

Conditions

Frailty; Malnutrition; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Results Point of Contact

• Title: Dr Samantha Meredith
• Organization: University of Southampton

s.j.meredith@soton.ac.uk

0238120

Study Officials

• Stephen ER Lim, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: October 28, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 10, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)