NCT05384730

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

Completed NA Results posted Last updated 23 May 2025

What this trial tests

NA trial testing Group nutrition and exercise support in Frailty in 32 participants. Completed in 10 January 2024.

Timeline

28 October 2022

Primary endpoint
1 October 2023

10 January 2024

Quick facts

Lead sponsor	University Hospital Southampton NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	32
Start date	28 October 2022
Primary completion	1 October 2023
Estimated completion	10 January 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• Group nutrition and exercise support

Conditions studied

• Frailty — all drugs for Frailty →
• Malnutrition — all drugs for Malnutrition →
• Sedentary Behavior — all drugs for Sedentary Behavior →

Sponsor

University Hospital Southampton NHS Foundation Trust

Who can join

65 and older, any sex, with Frailty or Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Volunteers Trained Primary · 6 months

The number of volunteers recruited to the study and trained.

Group	Value	95% CI
Hospital Volunteers	5

Volunteer Retention Primary · 6 months

The number of volunteers retained at the end of the study

Group	Value	95% CI
Hospital Volunteers	3

Adherence - Online Primary · post-intervention = 3-months

The percentage of online sessions completed

Group	Value	95% CI
Intervention Arm	75	38 – 92

Adherence - Telephone Support Primary · post-intervention= 3-months

The percentage of telephone sessions completed

Group	Value	95% CI
Intervention Arm	80	68.5 – 94.5

Device-based Physical Activity Levels Secondary · Baseline, post-intervention (3-months) and follow-up (6-months)

Device-based physical activity was measured using wrist-worn GENEActiv accelerometers, including light-physical activity, moderate-vigorous physical activity, and sedentary time (mins/day).

Light physical activity

Group	Value	95% CI
Baseline - Intervention Arm	29.95	± 21.07
Post-Intervention (3-month)	38.88	± 24.98
Follow-Up (6-month)	33.37	± 24.67

Moderate-vigorous physical activity

Group	Value	95% CI
Baseline - Intervention Arm	18.72	± 17.25
Post-Intervention (3-month)	23.08	± 18.87
Follow-Up (6-month)	21.02	± 18.12

Inactive/sedentary time

Group	Value	95% CI
Baseline - Intervention Arm	751.42	± 51.86
Post-Intervention (3-month)	744.39	± 43.84
Follow-Up (6-month)	731.01	± 52.69

Functional Ability Secondary · Baseline, post-intervention (3-months) and follow-up (6-months)

The Barthel Index scores 10 items describing activities of daily living and mobility, with a higher number being a reflection of greater ability to function independently following hospital discharge. Scores range from 0-20.

Group	Value	95% CI
Baseline - Intervention Arm	18	14 – 20
Post-Intervention (3-month)	19	17.5 – 20
Follow-Up (6-month)	20	16.5 – 20

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

Simplified Nutritional Appetite Questionnaire (SNAQ). SNAQ is a four-item tool assessing appetite, satiety, taste of food and number of meals per day. SNAQ has a minimum score of 4 and a maximum score of 20, with a score of ≤14 indicating poor appetite.

Group	Value	95% CI
Baseline - Intervention Arm	14.2	± 3.3
Post-Intervention (3-month)	15.4	± 2.3
Follow-Up (6-month)	15.6	± 2

Well-being Secondary · Baseline, Post-intervention (3-month) and follow-up (6-month)

Warwick-Edinburgh Well-Being Scale (WEMWBS). WEMWBS comprises 14 positively worded items relating to different aspects of positive mental health, including positive affect, satisfying interpersonal relationships and positive functioning. Each item is scored on a 5-point Likert scale from 1 (none of the time) to 5 (all of the time), with a higher score indicating a higher level of mental well-being. Total calculated scores range from 14-70.

Group	Value	95% CI
Baseline - Intervention Arm	49.5	± 8.2
Post-Intervention (3-month)	50.2	± 9.3
Follow-Up (6-month)	51.4	± 9.6

Depression and Anxiety Secondary · Baseline, post-intervention (3-month) and follow-up (6-month)

The Hospital Anxiety and Depression Scale (HADS). HADS comprises seven questions for anxiety and seven questions for depression. A score of 0-7 is normal, 8-10 borderline abnormal, and 11-21 abnormal. Scores can range from a minimum of 0 to a maximum of 21.

Depression

Group	Value	95% CI
Baseline - Intervention Arm	6	3.5 – 8
Post-Intervention (3-month)	3	1 – 5
Follow-Up (6-month)	4	3 – 7

Anxiety

Group	Value	95% CI
Baseline - Intervention Arm	4	2 – 6.5
Post-Intervention (3-month)	4	2 – 6.5
Follow-Up (6-month)	4	2.5 – 6

Patient's Subjective Assessment of Quality of Life Secondary · Baseline, Post-intervention (3-month) and follow-up (6-month)

Quality of life was measured using the EuroQol (EQ-5D-5L) assessment comprising a short descriptive questionnaire. The questionnaire includes 5 domains (e.g., mobility; self-care; usual activities; pain/discomfort; and anxiety/depression) measured with 5 response levels from 'no problems' to 'extreme problems/unable'. A health state index score was calculated from individual health profiles using UK value set data (0.000 \[minimum quality of life\] - 1.000 \[maximum quality of life\]).

Group	Value	95% CI
Baseline - Intervention Arm	0.683	0.489 – 0.708
Post-Intervention (3-month)	0.733	0.570 – 0.803
Follow-Up (6-month)	0.720	0.456 – 0.813

Self-efficacy for Managing Chronic Disease Secondary · Baseline, Post-intervention (3-month) and follow-up (6-month)

A 6-item scale will be used to assess participant's self-efficacy in managing their chronic disease. The scale contains items developed from the chronic disease self-management study covering domains, such as symptom control, role function, emotional functioning and communicating with health professionals. Each item is scored on a 10-point Likert scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate higher self-efficacy with scores ranging from 6-60.

Group	Value	95% CI
Baseline - Intervention Arm	37.4	± 9.2
Post-Intervention (3-month)	41.8	± 6.5
Follow-Up (6-month)	40.9	± 10.2

Self-reported Physical Activity Secondary · Baseline, Post-Intervention (3-month), Follow-Up (6-months)

Self-reported physical activity was measured using the physical activity scale for the elderly (PASE), which measures a broad spectrum of activities including leisure-time, household, and occupational PA during the previous 7 days. The PASE outcome is total self-reported physical activity which is scored from 0-400 with higher scores representing higher levels of physical activity.

Group	Value	95% CI
Baseline - Intervention Arm	32.8	± 35.2
Post-Intervention (3-month)	50.8	± 31.1
Follow-Up (6-month)	46.2	± 39.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Arm

Serious: 0/23 (0%)

Deaths: 0/23

Hospital Volunteers

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention Arm	Hospital Volunteers
Strained shoulder muscle	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT05384730 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Meredith SJ, Roberts H, Grocott MPW, Jack S, et al · · 2023 · cited 4× · PMID 36927597 · DOI 10.1136/bmjopen-2022-069533
2. Frail2Fit study: it was feasible and acceptable for volunteers to deliver a remote health intervention to older adults with frailty.
   Meredith SJ, Holt L, Varkonyi-Sepp J, Bates A, et al · · 2025 · PMID 41045456 · DOI 10.1016/j.tjfa.2025.100092