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A study exploring a personalised digital prehabilitation programme, Fit 4 Surgery (F4S), for patients undergoing major surgery

A mixed-methods study exploring the efficacy of a personalised digital prehabilitation programme, Fit 4 Surgery (F4S), for patients undergoing major surgery: A feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10633072
Enrollment
120
Registered
2023-08-30
Start date
2023-01-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery of physical function after major elective surgery for patients undergoing lung cancer, lung transplants, LVRS, and UGI surgeries Surgery

Interventions

All eligible patients will be given the F4S app which is tailored for individual patient needs using baseline data collected within the app. Specifically, the app collects baseline demographic data, c

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Major elective surgery for benign or malignant diseases 2. Able to provide written informed consent 3. Before surgery at time of consent 4. Age >18 years

Exclusion criteria

Exclusion criteria: 1. Emergency surgery required 2. Inability to perform project outcome measures

Design outcomes

Primary

MeasureTime frame
Qualitative interviews and technology acceptance questionnaires with patients and staff will be undertaken to provide an in-depth understanding of how F4S has been used, including compliance in practice and the barriers and facilitators to its optimal use.

Secondary

MeasureTime frame
1. Patient recovery, assessed by questionnaires, 1 month post-surgery. The feasibility study will measure the following at baseline, on the day of surgery, during hospital stay, on day of hospital discharge, 1 month after surgery, and 6 months after surgery: 1.1. Patient-reported outcomes: generic health (EQ-5D-5L), and disease specific (e.g., EORTC-QLQ-C30)-related quality of life. 1.2. Exercise capacity assessed by incremental shuttle walk test (ISWT) is an important secondary outcome measure following rehabilitation studies. 1.3. Mental health/well-being will be calculated using the Hospital Anxiety and Depression Scale; and using the Subjective Vitality Scale. 2. Clinical Outcomes - Complication rates using a modified Clavien-Dindo classification system and its derivative comprehensive complication index, length of stay in hospital/high dependency/intensive care, 30-day mortality, and readmission. 3. Process Measures - Being a complex intervention, a process evaluation based on the MRC guidance framework (2008) will be conducted building on three themes: implementation, mechanisms, and context. We will capture ‘fidelity’; ‘dose’, how it was delivered, ‘reach’ etc. via a modified TIDieR template.

Countries

England, United Kingdom

Contacts

Public ContactMatar Alzahrani
MSA033@bham.ac.uk+44 7426761268

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026