Prehabilitation in Patients on a Waiting List for a Transplant

NCT ID: NCT03314376

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2024-12-01

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.

Conditions

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Transplant Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Prehabilitation program

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

Group Type EXPERIMENTAL

Prehabilitation program

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andaluz Health Service

OTHER_GOV

Sponsor Role collaborator

University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Dr. Antonio I Cuesta-Vargas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio I Cuesta-Vargas, PhD

Role: STUDY_DIRECTOR

University of Malaga

Locations

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Malaga

Málaga, , Spain

Site Status

Countries

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Spain

References

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Arthur HM, Daniels C, McKelvie R, Hirsh J, Rush B. Effect of a preoperative intervention on preoperative and postoperative outcomes in low-risk patients awaiting elective coronary artery bypass graft surgery. A randomized, controlled trial. Ann Intern Med. 2000 Aug 15;133(4):253-62. doi: 10.7326/0003-4819-133-4-200008150-00007.

Reference Type BACKGROUND
PMID: 10929164 (View on PubMed)

Bao Y, Dalrymple L, Chertow GM, Kaysen GA, Johansen KL. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 2012 Jul 23;172(14):1071-7. doi: 10.1001/archinternmed.2012.3020.

Reference Type BACKGROUND
PMID: 22733312 (View on PubMed)

Levett DZ, Grocott MP. Cardiopulmonary exercise testing, prehabilitation, and Enhanced Recovery After Surgery (ERAS). Can J Anaesth. 2015 Feb;62(2):131-42. doi: 10.1007/s12630-014-0307-6. Epub 2015 Jan 22.

Reference Type BACKGROUND
PMID: 25608638 (View on PubMed)

Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.

Reference Type BACKGROUND
PMID: 24439570 (View on PubMed)

Smith TB, Stonell C, Purkayastha S, Paraskevas P. Cardiopulmonary exercise testing as a risk assessment method in non cardio-pulmonary surgery: a systematic review. Anaesthesia. 2009 Aug;64(8):883-93. doi: 10.1111/j.1365-2044.2009.05983.x.

Reference Type BACKGROUND
PMID: 19604193 (View on PubMed)

Cuesta-Vargas AI, Adams N, Salazar JA, Belles A, Hazanas S, Arroyo-Morales M. Deep water running and general practice in primary care for non-specific low back pain versus general practice alone: randomized controlled trial. Clin Rheumatol. 2012 Jul;31(7):1073-8. doi: 10.1007/s10067-012-1977-5. Epub 2012 Mar 29.

Reference Type BACKGROUND
PMID: 22453844 (View on PubMed)

Cuesta-Vargas AI, Heywood S. Aerobic fitness testing in chronic nonspecific low back pain: a comparison of deep-water running with cycle ergometry. Am J Phys Med Rehabil. 2011 Dec;90(12):1030-5. doi: 10.1097/PHM.0b013e318238a29c.

Reference Type BACKGROUND
PMID: 22019978 (View on PubMed)

Karmali KN, Davies P, Taylor F, Beswick A, Martin N, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2014 Jun 25;(6):CD007131. doi: 10.1002/14651858.CD007131.pub3.

Reference Type BACKGROUND
PMID: 24963623 (View on PubMed)

Other Identifiers

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PREHAB-T

Identifier Type: -

Identifier Source: org_study_id

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