Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT02522520
Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity.
There is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. However, the most frequently studied diagnosis group is women with breast cancer. Until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy
The purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy.
The hypothesis of the study are: 1. That both interventions will show a positive association between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy.
Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week).
Benefits and risks of participating: Possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. At participation in the interventions minor sports injuries may occur.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 weeks physical activity intervention (supervised/non-supervised)
12 weeks physical activity intervention (supervised/non-supervised)
Other names: Pedometer
Time frame: 12 weeks
Assessed with objective physiological test
Time frame: From baseline to 39 weeks
Assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, specifically for colon cancer patients
Time frame: From baseline to 39 weeks
Assessed by MD Andersen symptom questionnaire and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, chemotherapy-induced peripheral neuropathy
Time frame: From baseline to 39 weeks
Assessed by The Hospital Anxiety and Depression Scale
Time frame: From baseline to 39 weeks
Assessed by smoking cessation, alcohol, diet
Time frame: From baseline to 39 weeks
Assessed by the International Physical Activity Questionnaire
Time frame: From baseline to 39 weeks
Assessed by dual energy x-ray absorptiometry.
Time frame: From baseline to 39 weeks
Assessed by blood samples
Time frame: From 6 to 12 weeks
Assessed by Heart Rate Monitor during the hospital-based intervention
Time frame: From baseline to 12 weeks
Assessed by Omron Walking Style pro. 20 with electronic data transmission
Rigshospitalet, Denmark
Other
Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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