Trial Outcomes & Findings for Frail2Fit Study: Online Nutrition and Exercise Support for Older Adults With Frailty (NCT NCT05384730)

NCT ID: NCT05384730

Last Updated: 2025-05-23

Results Overview

The number of volunteers recruited to the study and trained.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-05-23

Participant Flow

Participant milestones

Measure	Intervention Arm 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers Hospital volunteers trained to deliver the Frail2Fit intervention
Overall Study STARTED	27	5
Overall Study COMPLETED	17	3
Overall Study NOT COMPLETED	10	2

Reasons for withdrawal

Measure	Intervention Arm 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers Hospital volunteers trained to deliver the Frail2Fit intervention
Overall Study Adverse Event	1	0
Overall Study Lack of social support	2	0
Overall Study Hospital readmission	2	0
Overall Study Disease progression	5	0
Overall Study Overwhelmed with College commitments	0	2

Baseline Characteristics

Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards

Baseline characteristics by cohort

Measure	Intervention Arm n=27 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=5 Participants Hospital volunteers were trained to deliver the Frial2Fit intervention	Total n=32 Participants Total of all reporting groups
Age, Continuous	80.3 years STANDARD_DEVIATION 7 • n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards	16.4 years STANDARD_DEVIATION 0.49 • n=5 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards	70 years STANDARD_DEVIATION 24.33 • n=31 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards
Sex: Female, Male Female	15 Participants n=27 Participants	3 Participants n=5 Participants	18 Participants n=32 Participants
Sex: Female, Male Male	12 Participants n=27 Participants	2 Participants n=5 Participants	14 Participants n=32 Participants
Race/Ethnicity, Customized Ethnicity · White British	26 Participants n=26 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	2 Participants n=5 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	28 Participants n=31 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed
Race/Ethnicity, Customized Ethnicity · Polish	0 Participants n=26 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	1 Participants n=5 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	1 Participants n=31 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed
Race/Ethnicity, Customized Ethnicity · Asian British	0 Participants n=26 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	1 Participants n=5 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	1 Participants n=31 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed
Race/Ethnicity, Customized Ethnicity · Chinese	0 Participants n=26 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	1 Participants n=5 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed	1 Participants n=31 Participants • One enrolled participant withdrew from the study before their baseline data collections were completed
Region of Enrollment United Kingdom	27 Participants n=27 Participants	5 Participants n=5 Participants	32 Participants n=32 Participants
Cognitive status (Mini Mental State Examination)	28 units on a scale n=26 Participants • Baseline characteristics in the intervention group were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.	—	28 units on a scale n=26 Participants • Baseline characteristics in the intervention group were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.
Charlson comorbidity index	4 units on a scale n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.	—	4 units on a scale n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.
Clinical frailty scale	6 units on a scale n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.	—	6 units on a scale n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.
Number of medications	9 count n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.	—	9 count n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.
Length of hospital stay	15 days n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.	—	15 days n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.
Body Mass Index	25.5 kg/m^2 n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.	—	25.5 kg/m^2 n=26 Participants • Baseline characteristics were not collected for 1 participant who underwent an operation and moved wards. We were only interested in measuring this characteristic for the intervention group and not the volunteers.

PRIMARY outcome

Timeframe: 6 months

Population: Does not apply to intervention group

The number of volunteers recruited to the study and trained.

Outcome measures

Measure	Intervention Arm 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=5 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Volunteers Trained	—	5 Participants	—	—

PRIMARY outcome

Timeframe: 6 months

Population: This measure was not applicable for the intervention group

The number of volunteers retained at the end of the study

Outcome measures

Measure	Intervention Arm 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=5 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Volunteer Retention	—	3 Participants	—	—

PRIMARY outcome

Timeframe: post-intervention = 3-months

Population: This measure is not applicable for the hospital volunteer group

The percentage of online sessions completed

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Adherence - Online	75 percentage of completed sessions Interval 38.0 to 92.0	—	—	—

PRIMARY outcome

Timeframe: post-intervention= 3-months

Population: This measure is not applicable for the hospital volunteer group

The percentage of telephone sessions completed

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Adherence - Telephone Support	80 percentage of completed sessions Interval 68.5 to 94.5	—	—	—

SECONDARY outcome

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

Population: This measure is not applicable for the hospital volunteer group

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

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Device-based Physical Activity Levels Light physical activity	29.95 mins/day Standard Deviation 21.07	38.88 mins/day Standard Deviation 24.98	33.37 mins/day Standard Deviation 24.67	—
Device-based Physical Activity Levels Moderate-vigorous physical activity	18.72 mins/day Standard Deviation 17.25	23.08 mins/day Standard Deviation 18.87	21.02 mins/day Standard Deviation 18.12	—
Device-based Physical Activity Levels Inactive/sedentary time	751.42 mins/day Standard Deviation 51.86	744.39 mins/day Standard Deviation 43.84	731.01 mins/day Standard Deviation 52.69	—

SECONDARY outcome

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

Population: This measure is not applicable for the hospital volunteer group

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.

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Functional Ability	18 units on a scale Interval 14.0 to 20.0	19 units on a scale Interval 17.5 to 20.0	20 units on a scale Interval 16.5 to 20.0	—

SECONDARY outcome

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

Population: This measure is not applicable for the hospital volunteer group

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.

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Appetite	14.2 score on a scale Standard Deviation 3.3	15.4 score on a scale Standard Deviation 2.3	15.6 score on a scale Standard Deviation 2	—

SECONDARY outcome

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

Population: This measure is not applicable for the hospital volunteer group

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.

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Well-being	49.5 score on a scale Standard Deviation 8.2	50.2 score on a scale Standard Deviation 9.3	51.4 score on a scale Standard Deviation 9.6	—

SECONDARY outcome

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

Population: This measure is not applicable for the hospital volunteer group

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.

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Depression and Anxiety Anxiety	4 score on a scale Interval 2.0 to 6.5	4 score on a scale Interval 2.0 to 6.5	4 score on a scale Interval 2.5 to 6.0	—
Depression and Anxiety Depression	6 score on a scale Interval 3.5 to 8.0	3 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 3.0 to 7.0	—

SECONDARY outcome

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

Population: This measure is not applicable for the hospital volunteer group

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]).

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Patient's Subjective Assessment of Quality of Life	0.683 Score on a scale Interval 0.489 to 0.708	0.733 Score on a scale Interval 0.57 to 0.803	0.720 Score on a scale Interval 0.456 to 0.813	—

SECONDARY outcome

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

Population: This measure is not applicable for the hospital volunteer group

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.

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Self-efficacy for Managing Chronic Disease	37.4 score on a scale Standard Deviation 9.2	41.8 score on a scale Standard Deviation 6.5	40.9 score on a scale Standard Deviation 10.2	—

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (3-month), Follow-Up (6-months)

Population: This measure is not applicable for the hospital volunteer group

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.

Outcome measures

Measure	Intervention Arm n=17 Participants 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=17 Participants Hospital volunteers were trained to deliver the frail2fit intervention	Follow-Up (6-month) n=17 Participants Frail2Fit intervention repeated measures - 3-month follow-up of data	Hospital Volunteers Hospital volunteers were trained to deliver the frail2fit intervention
Self-reported Physical Activity	32.8 PASE score on a scale Standard Deviation 35.2	50.8 PASE score on a scale Standard Deviation 31.1	46.2 PASE score on a scale Standard Deviation 39.8	—

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Hospital Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention Arm n=23 participants at risk 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. Group nutrition and exercise support: Weekly group nutrition and exercise support delivered online through trained volunteers	Hospital Volunteers n=5 participants at risk Hospital volunteers were trained to deliver the frail2fit intervention
Musculoskeletal and connective tissue disorders Strained shoulder muscle	4.3% 1/23 • Number of events 1 • 1 year	0.00% 0/5 • 1 year

Additional Information

Dr Samantha Meredith

University of Southampton

Phone: 0238120

Email: s.j.meredith@soton.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place