Prehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Operation With Reversal of External Stoma Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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'Cardiorespiratory and resistance training.

Group Type EXPERIMENTAL

Cardiorespiratory and resistance training.

Intervention Type 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.

Reference

Usual care.

Group Type ACTIVE_COMPARATOR

Reference

Intervention Type OTHER

No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.

Interventions

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Cardiorespiratory and resistance training.

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.

Intervention Type OTHER

Reference

No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.

Intervention Type OTHER

Other Intervention Names

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Usual care.

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age ≥ 18 years) suffering from colorectal diseases needing an operative treatment and treated along our ERAS pathway
* Patients suffering from colorectal cancer, diverticulosis, benign tumors such as polyps or inflammatory bowel disease and surgically treated (i.e. rectosigmoid resection, anterior resection of rectum, ileocaecal/right hemicolectomy, left hemicolectomy, abdominoperineal resection or total/subtotal colectomy), and patients undergoing reversal of Stoma and Hartmann procedures will be included.
* Informed Consent as documented by signature

Exclusion Criteria

* Patients suffering from severe dementia or other cognitive impairment, what hinders them to give informed consent
* Patients with a physical impairment, who can't perform the necessary physical Training
* Patients, who are not able or willing to attend the physical training at the institute of physiotherapy of the Kantonsspital Winterthur
* Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc.
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No