Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) Study: a randomized clinical trial

Patients after esophageal cancer surgery are often fatigued and have a
decreased health-related quality of life and physical functioning in the short-
and long-term. Therefore, interventions that potentially increase
health-related quality of life are strongly needed. Exercise training
interventions have been shown to effectively improve health-related quality of
life in patients with various types of cancer. So far, comparable evidence for
patients with esophageal cancer is lacking. We hypothesize that a 12-week
supervised combined endurance and resistance training intervention will increas
health-related quality of life in patients after esophageal cancer surgery with
curative intent.

Primary Objective:
- To investigate whether a 12-week exercise intervention increases HRQoL in
patients after curatively intended EC surgery compared to a usual care control
group.
Secondary Objective(s):
- To investigate whether a 12-week exercise intervention improves fatigue,
physical activity, physical fitness, functional wellbeing and symptoms,
esophagus-specific QoL, anxiety and depression, diet, sleep quality, body
composition, work ability and blood markers.
- To explore whether disease recurrence is lower and overall survival is higher
in the exercise group than in the control group.

Design: A single blind randomised controlled clinical study.

The standardized intervention combining endurance and resistance training will
take place twice weekly during 12 weeks and will be supervised by a
physiotherapist in an out-patient or general physiotherapy practice. The
control group will receive care as usual (no exercise program).

The patient will be asked three times to spend 45 minutes completing
questionnaires about general and mental health, fatigue, work ability, medical
history, and exercise habits. Patients will be asked to visit the research
center two times for physical examination, blood sampling and to perform
several physical tests: cardiopulmonary exercise testing, muscle strength
testing and assessment of body composition. Completing questionnaires and
physical tests might confront the patient with the consequences of his/her
disease which may be experienced as a psychological burden, but on the other
hand can also enhance the patients* confidence in his/her ability to be
physically active. Patients allocated to the intervention group are supposed to
participate in a 12-week combined endurance and resistance training program
twice weekly. To reduce the burden of travelling to the training facilities,
the training will take place in an out-patient or general physiotherapy
practice near by the patients* home. Injuries due to exercise can occur; to
minimize the risk the intensity of the exercise program will be gradually
increased during the study and the program will be supervised by a
physiotherapist. The estimated extra risk for the patient while participating
in this study is low.
Benefit: We expect that the exercise program will have a beneficial effect on
the patients* health status. The control group will be offered an exercise
advice at the end of the study.