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| Name | Class |
|---|---|
| University of Zurich | OTHER |
| Zurich University of Applied Sciences | OTHER |
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The purpose of this study is to determine whether a combined cardiorespiratory and strengthening training prior to colorectal surgery decreases the rate of surgery-related complications.
This single site study investigates whether a preoperative training reduces the number and severity of perioperative complications in patients undergoing elective colorectal surgery according to the Enhanced Recovery After Surgery (ERAS) pathway.
The study will be approved by a local ethical committee and conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP as well as all national legal and regulatory requirements. Before inclusion informed written consent will be obtained from all patients.
Once the indication for the surgical intervention is given patients may be included into the study. Patients of the experimental group will be provided with a tailored training program aiming at maximally improving physical fitness in order to withstand the surgical stress. Depending on the urgency of the operation this training program will last between two and six weeks. Three weekly trainings are foreseen of which two will be performed in a setting supervised by a physiotherapist and one at the patient's home.
Patients assigned to the control group receive the usual care i.e. information about the upcoming procedure and the advice to remain physically active.
From the point of the operation both groups will be treated equally. Outcome measures will be obtained from the inclusion into the study up to one month after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | 'Cardiorespiratory and resistance training. |
|
| Reference | Active Comparator | Usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiorespiratory and resistance training. | Other | A cardiorespiratory and resistance training program for at least 2 to 3 weeks will be conducted 3-times per week, of which two sessions will be supervised by a qualified person of the institute of physiotherapy and one session will be unsupervised and home-based. Physiotherapy consists of one hour, moderate to intense interval training combined with muscle strength training. |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complication Index (CCI) | ssessment of patients' overall morbidity. CCI is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clavien/Dindo | Assessment of post-surgical complications, ranging from Grade I (any deviation from normal postoperative Course) to Grade V (death of Patient). | 30 days |
| Five Times Sit to Stand Test |
| Measure | Description | Time Frame |
|---|---|---|
| The self-reported International Physical Activity Questionnaire short-form (IPAQ-SF) | The IPAQ is used as a comparable and standardised self-report measure of habitual physical activity. | 30 days |
| hand grip strength |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Breitenstein, MD, PD | Kantonsspital Winterthur KSW | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Winterthur | Canton of Zurich | 8401 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7891489 | Background | Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6. | |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Reference | Other | No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery. |
|
|
Time needed to raise from and sit-down on a chair for five times.
| 30 days |
| 2-Minute Walk Test | Distance covered within two minutes of brisk walking. | 30 days |
| Perceived pain | Numeric rating scale ranging from Zero (no pain) to ten (worst pain). | 30 days |
Jamar handheld dynamometer.
| 30 days |
| Rating of Perceived Exertion | Borg scale. | 30 days |
| Steep ramp test | Test to determine training intensity. | 30 days |
| Modified Iowa Levels of Assistance Scale (Milas) | Measure to quantify the gait and mobility impairments | 30 days |
| 23121372 | Background | Dronkers JJ, Chorus AM, van Meeteren NL, Hopman-Rock M. The association of pre-operative physical fitness and physical activity with outcome after scheduled major abdominal surgery. Anaesthesia. 2013 Jan;68(1):67-73. doi: 10.1111/anae.12066. Epub 2012 Nov 5. |
| 23728278 | Background | Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732. |
| 23052794 | Background | Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available. |
| 35084526 | Derived | Gloor S, Misirlic M, Frei-Lanter C, Herzog P, Muller P, Schafli-Thurnherr J, Lamdark T, Schregel D, Wyss R, Unger I, Gisi D, Greco N, Mungo G, Wirz M, Raptis DA, Tschuor C, Breitenstein S. Prehabilitation in patients undergoing colorectal surgery fails to confer reduction in overall morbidity: results of a single-center, blinded, randomized controlled trial. Langenbecks Arch Surg. 2022 May;407(3):897-907. doi: 10.1007/s00423-022-02449-0. Epub 2022 Jan 27. |
| 33782738 | Derived | Taha A, Taha-Mehlitz S, Staartjes VE, Lunger F, Gloor S, Unger I, Mungo G, Tschuor C, Breitenstein S, Gingert C. Association of a prehabilitation program with anxiety and depression before colorectal surgery: a post hoc analysis of the pERACS randomized controlled trial. Langenbecks Arch Surg. 2021 Aug;406(5):1553-1561. doi: 10.1007/s00423-021-02158-0. Epub 2021 Mar 29. |
| 29079551 | Derived | Merki-Kunzli C, Kerstan-Huber M, Switalla D, Gisi D, Raptis DA, Greco N, Mungo G, Wirz M, Gloor S, Misirlic M, Breitenstein S, Tschuor C. Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Oct 27;6(10):e199. doi: 10.2196/resprot.7972. |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |