Prehabilitation in Patients on a Waiting List for a Transplant

Transplant Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03314376
• Other study ID #: PREHAB-T
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2018
• Source: University of Malaga
• Contact: Antonio I Cuesta-Vargas, PhD
• Phone: 952137551
• Email: acuesta[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2021
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transplant Dysfunction

Intervention

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.

Locations

Country	Name	City	State
Spain	Malaga	Malaga

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	Andaluz Health Service

Country where clinical trial is conducted

Spain, 

References & 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. — View 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. — View Citation

Cuesta-Vargas AI, Adams N, Salazar JA, Belles A, Hazañas 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2019 Feb 01;2:CD007131. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative length of stay	Days that the patient is in the hospital after the surgery	10 min
Secondary	SF-12	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
Secondary	EuroQoL-5D	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
Secondary	Profile of Mood States	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
Secondary	Central Sensitization Inventory	Symptoms related to central sensitization	10 min
Secondary	Self-Efficacy/Social Support Scales for Activity	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
Secondary	Quadriceps strength	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
Secondary	Hamstring strength	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
Secondary	Brachial triceps strength	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
Secondary	Biceps brachii strength	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
Secondary	Hand grip strength	Hand grip strength will be evaluated by the hydraulic dynamometer Jamar.	5 min
Secondary	Orthogoniometry	The investigators will assess the mobility of the subject. It will be measured the muscular shortening using goniometry (grades=º).	10 min
Secondary	Biochemical markers (Haemogram)	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