Prehabilitation in Patients on a Waiting List for a Transplant

Not Applicable

Withdrawn

• Conditions: Transplant Dysfunction
• Interventions: Device: Prehabilitation program

• Registration Number: NCT03314376
• Lead Sponsor: University of Malaga

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-19
• Status Verified: 2018-12
• Study Start: 2020-01-02
• Primary Completion: 2024-01-02
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation program	Prehabilitation program	Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants.

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay	10 min	Days that the patient is in the hospital after the surgery

Secondary Outcome Measures

Name	Time	Method
EuroQoL-5D	10 min	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).
Profile of Mood States	10 min	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
SF-12	10 min	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).
Central Sensitization Inventory	10 min	Symptoms related to central sensitization
Quadriceps strength	5 min	Strength peak of knee extension (quadriceps) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels \& Worthingham (1995).
Hand grip strength	5 min	Hand grip strength will be evaluated by the hydraulic dynamometer Jamar.
Self-Efficacy/Social Support Scales for Activity	10 min	Social needs for the exercise. 4 dimensions (self-efficacy, family, staff and peers) will be assessed with 6 items per dimension (0-6).
Brachial triceps strength	5 min	Strength peak of elbow extension (brachial triceps) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels \& Worthingham (1995).
Biceps brachii strength	5 min	Strength peak of elbow flexion (biceps brachii) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels \& Worthingham (1995).
Orthogoniometry	10 min	The investigators will assess the mobility of the subject. It will be measured the muscular shortening using goniometry (grades=º).
Hamstring strength	5 min	Strength peak of knee flexion (hamstring) by one dynamometry instrumented with Powertruck II of Jtech, following the protocol described by Daniels \& Worthingham (1995).
Biochemical markers (Haemogram)	10 min	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).

Trial Locations

Locations (1)

Malaga; 🇪🇸 Malaga, Spain