Prehabilitation in Patients on a Waiting List for a Transplant

NCT03314376 | Withdrawn DMC

• 1 other identifier: PREHAB-T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Dysfunction

Keywords

prehabilitation; surgery; exercise program; transplant; postoperative

Outcome Measures

Primary Outcomes (1)

• Postoperative length of stay

  Days that the patient is in the hospital after the surgery

  10 min

Secondary Outcomes (12)

• SF-12

  10 min

• EuroQoL-5D

  10 min

• Profile of Mood States

  10 min

• Central Sensitization Inventory

  10 min

• Self-Efficacy/Social Support Scales for Activity

  10 min

Study Arms (2)

Prehabilitation program

EXPERIMENTAL

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

Device: Prehabilitation program

Control group

NO INTERVENTION

They will be instructed to continue their current activities and not to increase objectively levels of physical activity performed during the 6-week intervention.

Interventions

Prehabilitation program 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.

Prehabilitation program

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe cardiovascular disease.

Sponsors & Collaborators

• University of Malaga: lead
• Andaluz Health Service: collaborator

Study Sites (1)

Malaga

Málaga, 29009, Spain

Location

Related Publications (8)

• 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.

  PMID: 10929164 BACKGROUND

• 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.

  PMID: 22733312 BACKGROUND

• 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.

  PMID: 25608638 BACKGROUND

• 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.

  PMID: 24439570 BACKGROUND

• 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.

  PMID: 19604193 BACKGROUND

• 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.

  PMID: 22453844 BACKGROUND

• 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.

  PMID: 22019978 BACKGROUND

• 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.

  PMID: 24963623 BACKGROUND

Study Officials

• Antonio I Cuesta-Vargas, PhD

  University of Malaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 19, 2017
• Study Start: January 2, 2020
• Primary Completion: January 2, 2024
• Study Completion: December 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2018-12

Locations

ES (1)