Clinical trial NCT03314376: Prehabilitation in Patients on a Waiting List for a Transplant
Official title: Individualized Prehabilitation Program for Patients on a Waiting List for a Transplant.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Transplant Dysfunction
Keywords: prehabilitation
surgery
exercise program
transplant
postoperative
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2017-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative length of stay
timeFrame: 10 min
Secondary outcomes:
measure: SF-12
timeFrame: 10 min
measure: EuroQoL-5D
timeFrame: 10 min
measure: Profile of Mood States
timeFrame: 10 min
measure: Central Sensitization Inventory
timeFrame: 10 min
measure: Self-Efficacy/Social Support Scales for Activity
timeFrame: 10 min
measure: Quadriceps strength
timeFrame: 5 min
measure: Hamstring strength
timeFrame: 5 min
measure: Brachial triceps strength
timeFrame: 5 min
measure: Biceps brachii strength
timeFrame: 5 min
measure: Hand grip strength
timeFrame: 5 min
measure: Orthogoniometry
timeFrame: 10 min
measure: Biochemical markers (Haemogram)
timeFrame: 10 min
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Malaga
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta-Vargas, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.