Nutrition and Exercise Prehabilitation in Patients Awaiting Liver Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKalliopi Anna Poulia

About this trial

This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients awaiting liver transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture

Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation

No prior formal dietary advice

Disqualifiers

Age < 18 years old

Estimated waiting time for liver transplantation < 3 months

Estimated life expectancy < 3 months

Chronic kidney disease requiring protein restriction

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diet with even protein distribution plus exercise program

    Behavioral

    Diet of 1.2-1.5 g protein/kg dry body weight/day, equally divided (33.3% at 3 main meals) \| Exercise program: 3 days/week aerobic and 2 days/week resistance \| Duration: 12 weeks

  • Diet with skewed protein distribution plus exercise program

    Behavioral

    Diet of 1.2-1.5 g protein/kg dry body weight/day, unequally divided (10.0% at breakfast, 60.0% at lunch, 30.0% at dinner) \| Exercise program: 3 days/week aerobic and 2 days/week resistance \| Duration: 12 weeks

  • Standard dietary and physical activity advice

    Behavioral

    Standard dietary and physical activity advice \| Duration: 12 weeks

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Diet with even protein distribution plus exercise programExperimental treatment 1 intervention
Group B: Diet with skewed protein distribution plus exercise programExperimental treatment 1 intervention
Group C: Standard dietary and physical activity adviceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition

Malnutrition will be diagnosed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least 1 phenotypic criterion and 1 etiologic criterion. Phenotypic criteria include: a. Non-votional weight loss (%): \> 5% within past 6 months or \> 10% beyond 6 months, b. Low body mass index (BMI, kg/m\^2): \< 20 kg/m\^2 if \< 70 years or \< 22 kg/m\^2 if \> 70 years, c. Reduced muscle mass, assessed by validated body composition measuring techniques \[e.g. Dual-Energy X-ray Absorptiometry (DEXA), Bioelectrical Impedance Analysis (BIA) or Computed Tomography (CT)\]. Etiologic criteria include: a. Reduced food intake or assimillation: ≤ 50% of energy requirements \> 1 week or any reduction for \> 2 weeks or any chronic gastrointestinal condition that adversely impacts food assimilation or absorption, b. Inflammation: acute disease/injury or chronic disease-related.

Time frame
Baseline, 12 weeks
2

Changes in Computed Tomography (CT)-derived muscle mass

Muscle mass will be assessed using the Skeletal Muscle Index (SMI, cm\^2/m\^2). SMI will be calculated by measuring the total cross-sectional area of skeletal muscles, from a single cross-sectional Computed Tomography (CT) image at L3 vertebral level, using Hounsfield Units of -29 to +150 HU, and normalizing to height squared (m\^2).Thresholds for reduced SMI will be considered \< 50 cm\^2/m\^2 for men and \< 39 cm\^2/m\^2 for women.

Time frame
Baseline, 12 weeks
3

Changes in handgrip strength (kg)

Handgrip strength (kg) will be assessed using a digital handgrip dynamometer. Thresholds for reduced muscle strength will be considered \< 27 kg for men and \< 16 kg for women.

Time frame
Baseline, 12 weeks
4

Changes in Short Physical Performance Battery (SPPB) score

The Short Physical Performance Battery (SPPB) includes 3 components: 3-positions balance testing (sec) (0-4 points), 4-meter gait speed test (sec) (0-4 points) and 5-times chair stand test (sec) (0-4 points), with a total score of 0-12. Higher scores indicate a better physical performance: 0-3 points for worst physical performance, 4-9 points for reduced physical performance and 10-12 points for best physical performance.

Time frame
Baseline, 12 weeks

Secondary outcomes

1

Nutritional Risk Screening-2002 (NRS-2002)-derived nutritional risk

Nutritional risk will be assessed using the Nutritional Risk Screening-2002 (NRS-2002) tool. Higher scores indicate greater nutritional risk: \< 3 points indicate good nutritional status and ≥ 3 nutritional risk.

Time frame
Baseline
2

Malnutrition Screening Tool (MST)-derived nutritional risk

Nutritional risk will be assessed using the Malnutrition Screening Tool (MST) tool. Higher scores indicate greater nutritional risk: \< 2 points indicate good nutritional status and ≥ 2 nutritional risk.

Time frame
Baseline
3

Malnutrition Universal Screening Tool (MUST)-derived nutritional risk

Nutritional risk will be assessed using the Malnutrition Universal Screening Tool (MUST) tool. Higher scores indicate greater nutritional risk: 0 points indicate low risk, 1 point medium risk and ≥ 2 high risk.

Time frame
Baseline
4

Short Nutritional Assessment Questionnaire (SNAQ)-derived nutritional risk

Nutritional risk will be assessed using the Short Nutritional Assessment Questionnaire (SNAQ) tool. Higher scores indicate greater nutritional risk: 0-1 points indicate low risk, 2 points medium risk and ≥ 3 points high risk.

Time frame
Baseline

Other outcomes

1

Adherence to the program

Adherence to the program will be assessed using 24-hour recalls and physical activity diaries.

Time frame
4 weeks, 8 weeks, 12 weeks
2

Satisfaction with the program

Satisfaction with the program will be assessed using a Likert scale: very satisfied, fairly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied and not at all satisfied

Time frame
12 weeks
3

Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition

Malnutrition will be diagnosed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least 1 phenotypic criterion and 1 etiologic criterion. Phenotypic criteria: a. Non-votional weight loss (%): \> 5% within past 6 months or \>10% beyond 6 months b. Low body mass index (BMI, kg/m\^2): \< 20 kg/m\^2 if \< 70 years or \< 22 kg/m\^2 if \> 70 years c. Reduced muscle mass, assesses by validated body composition measuring techniques \[e.g. Dual-Energy X-ray Absorptiometry (DEXA), Bioelectrical Impedance Analysis (BIA) or Computed Tomography (CT) Etiologic criteria: a. Reduced food intake or assimillation: ≤ 50% of energy requirements \> 1 week or any reduction for \> 2 weeks or any chronic gastrointestinal condition that adversely impacts food assimilation or absorption b. Inflammation: acute disease/injury or chronic disease-related

Time frame
3 months post-transplantation
4

Computed Tomography (CT)-derived muscle mass

Muscle mass will be assessed using the Skeletal Muscle Index (SMI, cm\^2/m\^2). SMI will be calculated by measuring the total cross-sectional area of skeletal muscles, from a single cross-sectional Computed Tomography (CT) image at L3 vertebral level, using Hounsfield Units of -29 to +150 HU, and normalizing to height squared (m\^2).Thresholds for reduced SMI will be considered \< 50 cm\^2/m\^2 for men and \< 39 cm\^2/m\^2 for women.

Time frame
3 months post-transplantation

Sponsors and contacts

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Kalliopi Anna Poulia

Lead sponsor

Agricultural University of Athens

Sponsor institution

Laikο General Hospital, Athens

Collaborator