Prehabilitation in Patients on a Waiting List for a Transplant

September 27, 2019 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antonio I Cuesta-Vargas, PhD
  • Phone Number: 34 952137551
  • Email: acuesta@uma.es

Study Locations

  • Spain
      • Malaga, Spain, 29009
        • Malaga
        • Contact:
          • Antonio I Cuesta-Vargas, PhD
          • Phone Number: 34 952137551
          • Email: acuesta@uma.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prehabilitation program
Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants.
Device: Prehabilitation program

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.
NO_INTERVENTION: Control group
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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Mood States
Time Frame: 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
10 min
SF-12
Time Frame: 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).
10 min
EuroQoL-5D
Time Frame: 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).
10 min
Central Sensitization Inventory
Time Frame: 10 min
Symptoms related to central sensitization
10 min
Self-Efficacy/Social Support Scales for Activity
Time Frame: 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).
10 min
Quadriceps strength
Time Frame: 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).
5 min
Hamstring strength
Time Frame: 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).
5 min
Brachial triceps strength
Time Frame: 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).
5 min
Biceps brachii strength
Time Frame: 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).
5 min
Hand grip strength
Time Frame: 5 min
Hand grip strength will be evaluated by the hydraulic dynamometer Jamar.
5 min
Orthogoniometry
Time Frame: 10 min
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)
Time Frame: 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).
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Collaborators

Andaluz Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 2, 2020

Primary Completion (ANTICIPATED)

January 2, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

October 5, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (ACTUAL)

October 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PREHAB-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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