Trimodal Prehabilitation for Aneurysm Surgery Study

NCT02292927 | Completed Results

• 1 other identifier: 14/LO/1368
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation program in a cohort of patients undergoing aneurysm repair. This will enable the design (feasibility and power) of a large scale Randomised Controlled Trial. Expected outcomes

• The potential number of patients who would benefit, the compliance and acceptability of a pre-operative prehabilitation programme will be calculated.
• Preoperatively, expected at 6-weeks, the change in physical fitness of patients (assessed by the physical function section of SF-36 and measured with peak flow/6-minute walk testing) during the pre-operative phase will be assessed in both groups.
• The effects on quality of life, anxiety and depression on each study participant will be assessed immediately pre-op, expected at 6-weeks.
• The number of patients who are able to reduce or cease smoking will be reported during the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic surgery, expected at 6-8 weeks. POPULATION: Patients undergoing planned elective aortic surgery procedures ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative exercise programme DURATION: 1 year from 1st June 2014

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (4)

• The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme

  This describes the number of people within the study who were in the pre-habilitation study arm that accepted and completed the pre-habilitation training

  Collected at screening

• Change From Baseline in Metabolic Equivalents (METS) at Six Weeks

  • Metabolic equivalent level is a measure of physical fitness. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival," or similar definition that is accurate and appropriate.

  Collected at baseline and (expected) 6 weeks

• Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale)

  HADS is a validated questionnaire consisting of 7 statements relating to anxiety and 7 statements relating to depression. Each statement is scored between 0 and 3 giving a total score of up to 21 for each section. A score of 0-7 is assumed to be normal and score greater than this suggestive of a mood disorder

  Collected at baseline and (expected) 6 weeks

• Number of Participants With Attendance at the Physical and Psychological and Social Training Appointments of the Rehabilitation Programme (Assessed by Bespoke Questionnaire)

  Collected at baseline and during the study

Secondary Outcomes (2)

• HDU/ITU Resource Use (Number of Days Stay)

  Collected at (expected) 6 weeks +hospital stay

• LOS

  Collected at (expected) 6 weeks +hospital stay

Study Arms (2)

Pre-intervention

NO INTERVENTION

Patients treated as standard before intervention

Post-intervention arm = Prehabilitation

ACTIVE COMPARATOR

Introduction of rehabilitation program

Behavioral: Post-intervention arm = Prehabilitation

Interventions

Post-intervention arm = Prehabilitation BEHAVIORAL

Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice

Post-intervention arm = Prehabilitation

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patients undergoing elective repair, willing/able to undertake a period of prehabilitation, and those able to comprehend and retain instructions regarding self-training.

You may not qualify if:

• \- Symptomatic patients or those undergoing urgent treatment (\< 2 weeks)

Sponsors & Collaborators

• Imperial College London: lead

Related Publications (14)

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  PMID: 17013852 BACKGROUND

• Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.

  PMID: 21878237 BACKGROUND

• Kim DJ, Mayo NE, Carli F, Montgomery DL, Zavorsky GS. Responsive measures to prehabilitation in patients undergoing bowel resection surgery. Tohoku J Exp Med. 2009 Feb;217(2):109-15. doi: 10.1620/tjem.217.109.

  PMID: 19212103 BACKGROUND

• Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

  PMID: 23052535 BACKGROUND

• Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.

  PMID: 20602503 BACKGROUND

• Dunckley M, Ellard D, Quinn T, Barlow J. Coronary artery bypass grafting: patients' and health professionals' views of recovery after hospital discharge. Eur J Cardiovasc Nurs. 2008 Mar;7(1):36-42. doi: 10.1016/j.ejcnurse.2007.06.001. Epub 2007 Jul 23.

  PMID: 17644041 BACKGROUND

• Kiecolt-Glaser JK, Page GG, Marucha PT, MacCallum RC, Glaser R. Psychological influences on surgical recovery. Perspectives from psychoneuroimmunology. Am Psychol. 1998 Nov;53(11):1209-18. doi: 10.1037//0003-066x.53.11.1209.

  PMID: 9830373 BACKGROUND

• Devine EC. Effects of psychoeducational care for adult surgical patients: a meta-analysis of 191 studies. Patient Educ Couns. 1992 Apr;19(2):129-42. doi: 10.1016/0738-3991(92)90193-m.

  PMID: 1299818 BACKGROUND

• Mumford E, Schlesinger HJ, Glass GV. The effect of psychological intervention on recovery from surgery and heart attacks: an analysis of the literature. Am J Public Health. 1982 Feb;72(2):141-51. doi: 10.2105/ajph.72.2.141.

  PMID: 7055315 BACKGROUND

• Furze G, Dumville JC, Miles JN, Irvine K, Thompson DR, Lewin RJ. "Prehabilitation" prior to CABG surgery improves physical functioning and depression. Int J Cardiol. 2009 Feb 6;132(1):51-8. doi: 10.1016/j.ijcard.2008.06.001. Epub 2008 Aug 15.

  PMID: 18703241 BACKGROUND

• Owen D, Bicknell C, Hilton C, Lind J, Jalloh I, Owen M, Harrison R. Preoperative smoking cessation: a questionnaire study. Int J Clin Pract. 2007 Dec;61(12):2002-4. doi: 10.1111/j.1742-1241.2007.01565..x. Epub 2007 Sep 10.

  PMID: 17850308 BACKGROUND

• 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

• Cunningham MA, Swanson V, O'Carroll RE, Holdsworth RJ. Randomized clinical trial of a brief psychological intervention to increase walking in patients with intermittent claudication. Br J Surg. 2012 Jan;99(1):49-56. doi: 10.1002/bjs.7714. Epub 2011 Oct 28.

  PMID: 22038532 BACKGROUND

• Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.

  PMID: 2782256 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

There was a significant failure in patients undergoing METS and HADS assessment prior to surgery and therefore the results of this pilot study are limited to a lot study of whether patients accepted this intensive rehabilitation study.

Results Point of Contact

• Title: Colin Bicknell
• Organization: Imperial Colege London

alison.deslandes@imperial.nhs.uk

02033126072

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share