Prehabilitation in Patients on a Waiting List for a Transplant

Study Overview
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Brief Summary
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The aim of this study is to prove the effects of a individualized prehabilitation program (muscular strength and endurance) in patients in a waiting list for a transplant. The investigators want to see if patients that did a prehabilitation program have better results in the postoperative period.

Detailed Description
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Some characteristics of the fragile people, like as sarcopenia, are related with worse results after a transplant. Increasing the cardiorespiratory fitness with an exercise program during the preoperative period has shown improvements in patients after a surgery. It is produced a decreased in his functions, including a loss of muscle mass. Prehabilitation is a exercise program before a surgery. This program will improve the patient's starting functional status and therefore recovery. Physical activity is one of the most powerful predictors of mortality risk. Several studies say that a improved cardiorespiratory fitness by exercise before a surgery has a great impact in the patients after the intervention in short and long term.

Official Title
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Individualized Prehabilitation Program for Patients on a Waiting List for a Transplant.

Conditions
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Transplant Dysfunction

Intervention / Treatment
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* Device: Prehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on a waiting list for a transplant. Fried Fragility Index >3 Space more than 6 week between the beginning of the exercise program and the surgery. Exclusion Criteria: Severe cardiovascular disease.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation program<br>Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants. | Device: Prehabilitation program<br>* The intervention will be an 6-week program of individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants. Each program will be individualized based on the evaluations of muscular strength and endurance as well as determination of aerobic-anaerobic zone transition described in previous studies In sessions of one hour 3 times a week. Each session will consist of 30 minutes of exercises performed on land followed by 20 minutes of continuous running in treadmill. In week 1 and 2 participants carry out 3 sets of 15 repetitions (reps) to become familiar with the exercises. From week 3 onwards participants will perform 4 sets of 10 reps. If the participant can do more than 12 reps, weight will be increased. All exercises are conducted supervised to ensure proper technique and adequate progression.<br>|
| No Intervention: Control group<br>They will be instructed to continue their current activities and not to increase objectively levels of physical activity performed during the 6-week intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay | Days that the patient is in the hospital after the surgery | 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 | The state of physical and mental health. SF-12 is a self-administered instrument with 12 items on physical and mental health status; responses are scored (for intensity or frequency) on a Likert-type scale (3-6 points according to the item). This instrument has shown adequate reliability (ICC = 0.73-0.86). | 10 min | 
| EuroQoL-5D | Quality of life. An auto-informed questionnaire consists of health problems related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems or extreme problems. Answers are given related to the day when patient completes the questionnaire. A quality of life visual analogue scale or VAS ('Best imaginable health state' (100) and 'Worst imaginable health state' (0)). This instrument has shown adequate reliability (0.86 and 0.90). | 10 min | 
| Profile of Mood States | It is possible to obtain an overall index of altered mood and seven partial measures: stress / anxiety, depression / rejection, anger / hostility, vigor / activity, fatigue / inertia and confusion / bewilderment | 10 min | 
| Central Sensitization Inventory | Symptoms related to central sensitization | 10 min | 
| Self-Efficacy/Social Support Scales for Activity | Social needs for the exercise. 4 dimensions (self-efficacy, family, staff and peers) will be assessed with 6 items per dimension (0-6). | 10 min | 
| Quadriceps strength | Strength peak of knee extension (quadriceps) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels & Worthingham (1995). | 5 min | 
| Hamstring strength | Strength peak of knee flexion (hamstring) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels & Worthingham (1995). | 5 min | 
| Brachial triceps strength | Strength peak of elbow extension (brachial triceps) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels & Worthingham (1995). | 5 min | 
| Biceps brachii strength | Strength peak of elbow flexion (biceps brachii) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels & Worthingham (1995). | 5 min | 
| Hand grip strength | Hand grip strength will be evaluated by the hydraulic dynamometer Jamar. | 5 min | 
| Orthogoniometry | The investigators will assess the mobility of the subject. It will be measured the muscular shortening using goniometry (grades=º). | 10 min | 
| Biochemical markers (Haemogram) | It will be measured in blood samples following clinical standards in 10 ml venous blood. The markers will be HB (hemoglobin), TLC (total WBC count), RBC count, MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin), MCHC (mean corpuscular hemoglobin concentration), neutrophils, lymphocytes, monocytes, eosinophils, basophils, PCV (packed cell volume), platelet count, P/S (peripheral smear) examination, RDW-SD (RBC distribution width-standard deviation), RDW-CV (RBC distribution width-coefficient of variation), PDW (platelet distribution width), MPV (mean platelet volume), P-LCR (platelet large cell ratio), PCT (platelet crit), absolute neutrophils count, absolute lymphocytes count, absolute monocytes count, absolute eosinophils count, absolute basophils count, and ESR (erythrocyte sedimentation rate). | 10 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, prehabilitation, exercise program, transplant, postoperative