Table 1

EXALT trial schedule

Study visitsBaselineEnd-of-
intervention
Follow-up
Preliver transplant (LT) (variable time-line)TransplantPost-LT (fixed time-line)
Visit 1Visit 2Visit 3Visit 4Visit 5Visit 6Inpatient stayVisit 7Visit 8Visit 9Visit 10
Time points0 weeks6 weeks12 weeks24 weeks36 weeks48 weeks52 week cut-off*6 weeks post12 weeks post24 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)
ConsentX
Randomisation (intervention vs control))X
Clinical examination and review (routine clinic)XXXXXXXXXXXX
Standard bloods pre-LT (FBC, U+E, LFTs, AST, GGT, INR, CRP, nutrition, ammonia)XXXXXXX
Standard bloods post-LT (FBC, U+E, LFTs, AST, GGT, INR, CRP, nutrition, tacrolimus)XXXXX
Standard clinic observations (BP, dry BMI, weight, hand grip strength, MAMC)XXXXXXXXXXXX
Frailty/functionality assessment (LFI, DASI)XXXXXXXXXXXX
Primary outcome SF-36v2 questionnaireXXXXXXXXXXX
Behavioural/psychological questionnaires (HCCQ, PNES, BREQ-2)XXXXXXXXXXX
Serious adverse events (complications/morbidity)XXXXXXXXXXXX
LT data (date, donor details, organ support, ICU stay)X
Exercise adherence: review participant ‘exercise’ diaryXXXXXXXXXX
Exercise Adherence: AcceleromterWeeks 0–24–610–1222–24Weeks 4–610–1222–24
Mechanistic 'muscle' substudy (n=100, optional):
 CPET, muscle USS, 6MWT, specialist biomarkersXX(X)X
Interventions:
 Intervention: home-based exercise and theory-based motivation support programmeXXXXXXXXXX
 Intervention: Telecall (15–30 min)Week 2,48, 1016,204816
 Control: standard of care patient ‘exercise’ advice leafletXX
  • *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.