Prehabilitation in Patients on a Waiting List for a Transplant

June 2, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Antonio I Cuesta-Vargas, PhD
  • Phone Number: 34 952137551
  • Email: acuesta@uma.es

Study Locations

  • Spain
      • Malaga, Spain, 29009
        • Malaga

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaga

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Andaluz Health Service

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Antonio I Cuesta-Vargas, PhD, University of Malaga

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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