An interventional study of Prehabilitation group in Esophageal Cancer and Gastric Cancer, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment
Objectives: The primary objective of this study is to assess the feasibility of a internet-based preoperative exercise program in patients with esophageal or gastric cancers. Secondary objectives are to evaluate the effects of this preoperative program on functional capacity, anxiety and depression, quality of life and fatigue Methods: This feasibility study will be conduct at University Hospital Saint-Luc in Brussels. Twenty patients with esophageal or gastric cancers will participate in internet-based program 3 sessions per week. Each session will combine aerobic and resistance training. Moreover, inspiratory muscle strengthening (IMT) will be performed daily. The researcher will conduct weekly telephone calls to educate and motivate subjects. Assessments will be performed at baseline, one day before surgery, 1 month and 3 months after surgery. The following parameters will be measured: functional capacity, quality of life, fatigue, anxiety and depression.
Exclusion Criteria:
Subjects will carry out a preoperative internet-based program including aerobic and resistance training three sessions per week
Behavioral: Prehabilitation group
Subjects will performed an internet-based exercise program before surgery
Retention rate
Proportion of patients who complete the tele-prehabilitation and all assessments
Time frame: At study completion (3 months after surgery)
Attendance
(Number of completed sessions/Number of planned sessions) x 100
Time frame: At study completion (3 months after surgery)
Program satisfaction
Program satisfaction will be evaluated by a questionnaire including items about internet program
Time frame: At study completion (3 months after surgery)
Percentage of patients who experienced one or more adverse events
Adverse events will be evaluated by listing adverse events that occur (e.g. fall, injury or exercise-related symptom)
Time frame: At study completion (3 months after surgery)
Recruitment rate
ratio of the number of the recruited patients to the number of eligible patients
Time frame: At study completion (3 months after surgery)
Change in functional capacity
Functional capacity will be assessed by 6-minute walk test
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Change in quality of life
Quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G). Each item is rated from 0 (not at all) to 4 (very much) with a total score ranging from 0 to 102. The higher the score, the better the QoL.
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Change in fatigue
Fatigue using the Functional Assessment of Cancer Therapy-Fatigue questionnaire (FACIT-F). Each item is rated from 0 (not at all) to 4 (very much) with a total score ranging from 0 to 52. The higher the score, the lower the fatigue.
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Change in anxiety and depression
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Scores for each subscale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values, and values from 11-21 are considered to be pathological
Time frame: Baseline, one day before surgery, 1 and 3 months after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain