Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy

NCT02478996 | Unknown

• 1 other identifier: AFSM-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate, if an intensive individually adaptated training program via online supervision during neoadjuvant therapy will improve lung function and reduce pulmonary complications following esophagectomy for Barrett's cancer.

Conditions

Barrett Esophagus

Keywords

perioperative; internet-based; exercise program

Outcome Measures

Primary Outcomes (1)

• peak oxygen uptake (VO2peak)

  First measurement three months prior to surgery (baseline), Second measurement immediately before surgery, third measurement three months after esophagectomy

  6 months

Secondary Outcomes (6)

• Gastric conduit failure after esophagectomy

  intraoperative

• pneumonia

  intraoperative

• duration of mechanical ventilation

  intraoperative

• re-intubation rate

  intraoperative

• Duration of intensive care unit stay

  intraoperative

Other Outcomes (1)

• feasibility of the online-based sports program

  6 months

Study Arms (2)

Internet-based exercise program

EXPERIMENTAL

The intervention group is supervised by a sports scientist eight to twelve weeks before and after surgery. Patients receive an individually designed intensive exercise program based on the functional and Fitness measurements at first diagnosis.

Other: Internet-based exercise program

Basis therapy

NO INTERVENTION

Participants of the Treatment as usual (TAU) group receive written information material enlightening the importance of regular physical activities and general releases on preparation for esophagectomy.

Interventions

Internet-based exercise program OTHER

Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training

Internet-based exercise program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven adenocarcinoma of the esophagus or adenocarcinoma of the esophagogastric junction type I according to Siewert's classification, clinical stages IIB-IIIC (T3/T4 and/or N+; M0) according to Union Internationale Contre le Cancer (UICC), 7th Edition
• Resectable stage according to discussion in the local multidisciplinary tumor board (MDT) of the participating centers and patient medically fit for multimodality therapy (ECOG performance status at least 1 or better, no severe impairment of cardiac, renal, hepatic, endocrine, bone marrow and cerebral functions)
• Planned abdominal-thoracic esophagectomy with gastric pull-up and intrathoracic or cervical anastomosis
• Cognitive ability of the patient to understand the perioperative program and to participate actively

You may not qualify if:

• Presence of a second malignant tumor (unless curatively treated \> 5 years ago)
• Chemotherapy or radiochemotherapy in patient's history
• Orthopedic, rheumatologic, cardiovascular or neurologic (epilepsy, stroke, Parkinson's disease, muscle wasting diseases such as amyotrophic lateral sclerosis or multiple sclerosis) contraindications for the sports program
• Inability to use the internet or no internet Access
• Inability to communicate in German
• Each active disease, which hinders completion of the study
• Active alcoholism or illegal drug consumption within the last six months before study entry

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

Department of Visceral, Transplantation, Vascular and Thoracic Surgery

Leipzig, 04103, Germany

RECRUITING

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• Pfirrmann D, Haller N, Huber Y, Jung P, Lieb K, Gockel I, Poplawska K, Schattenberg JM, Simon P. Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric Disorders: Process Evaluation of 4 Ongoing Clinical Trials. JMIR Res Protoc. 2018 May 22;7(5):e106. doi: 10.2196/resprot.8607.

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  PMID: 28615010 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Perikles Simon, Prof.Dr.Dr.

  Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University of Mainz

  PRINCIPAL INVESTIGATOR

• Ines Gockel, Prof. Dr.

  Department of Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Pfirrmann

CONTACT

+49 6131 392 3571; pfirrma@uni-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 23, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

DE (1)