Study visits | Baseline | End-of- intervention | Follow-up | |||||||||
Preliver transplant (LT) (variable time-line) | Transplant | Post-LT (fixed time-line) | ||||||||||
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Inpatient stay | Visit 7 | Visit 8 | Visit 9 | Visit 10 | ||
Time points | 0 weeks | 6 weeks | 12 weeks | 24 weeks | 36 weeks | 48 weeks | 52 week cut-off* | 6 weeks post | 12 weeks post | 24 weeks post | 48 weeks post | |
(±7 days) | (±7 days) | (±7 days) | (±14 days | (±14 days) | day 10±3 days | (±7 days) | (±7 days) | (±14 days) | (±14 days) | |||
Consent | X | |||||||||||
Randomisation (intervention vs control)) | X | |||||||||||
Clinical examination and review (routine clinic) | X | X | X | X | X | X | X | X | X | X | X | X |
Standard bloods pre-LT (FBC, U+E, LFTs, AST, GGT, INR, CRP, nutrition, ammonia) | X | X | X | X | X | X | X | |||||
Standard bloods post-LT (FBC, U+E, LFTs, AST, GGT, INR, CRP, nutrition, tacrolimus) | X | X | X | X | X | |||||||
Standard clinic observations (BP, dry BMI, weight, hand grip strength, MAMC) | X | X | X | X | X | X | X | X | X | X | X | X |
Frailty/functionality assessment (LFI, DASI) | X | X | X | X | X | X | X | X | X | X | X | X |
Primary outcome SF-36v2 questionnaire | X | X | X | X | X | X | X | X | X | X | X | |
Behavioural/psychological questionnaires (HCCQ, PNES, BREQ-2) | X | X | X | X | X | X | X | X | X | X | X | |
Serious adverse events (complications/morbidity) | X | X | X | X | X | X | X | X | X | X | X | X |
LT data (date, donor details, organ support, ICU stay) | X | |||||||||||
Exercise adherence: review participant ‘exercise’ diary | X | X | X | X | X | X | X | X | X | X | ||
Exercise Adherence: Acceleromter | Weeks 0–2 | 4–6 | 10–12 | 22–24 | Weeks 4–6 | 10–12 | 22–24 | |||||
Mechanistic 'muscle' substudy (n=100, optional): | ||||||||||||
CPET, muscle USS, 6MWT, specialist biomarkers | X | X | (X) | X | ||||||||
Interventions: | ||||||||||||
Intervention: home-based exercise and theory-based motivation support programme | X | X | X | X | X | X | X | X | X | X | ||
Intervention: Telecall (15–30 min) | Week 2,4 | 8, 10 | 16,20 | 4 | 8 | 16 | ||||||
Control: standard of care patient ‘exercise’ advice leaflet | X | X |
*52 (+2) week cut-off: study intervention will stop if participant has not had their LT by 52 weeks. (X) optional substudy consent if have not undergone LT within the 1-year time frame.
AST, aspartate transferase; BMI, body mass index; BP, blood pressure; BREQ-2, Behavioural Regulation in Exercise Questionaire-2; CPET, cardiopulmonary exercise test; CRP, C reactive protein; DASI, Duke Activity Status Index; EXALT, EXercise and motivAtional programme before and after Liver Transplantation; FBC, full blood count; GGT, gamma-glutamyl transferase; HCCQ, Healthcare Climate Questionnaire; ICU, intensive care unit; INR, international normalised ratio; LFI, Liver frailty index; LFTs, liver function tests; MAMC, mid-arm muscle circumference; 6MWT, 6 min walk test; PNES, Psychological Need Satisfaction in Exercise Scale; U+E, urea and electrolyte; USS, Ultrasound.