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Completed

NCT Number: NCT02522520

Pedometer Intervention and Health Effects for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with colorectal cancer in adjuvant chemotherapy
  • Age 18+ years
  • WHO performance status of 0 or 1
  • Undergone surgery at least 6 weeks ago
  • Do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week.

Exclusion criteria

  • Myocardial infarction within the past six months
  • Symptomatic heart failure
  • Known angina pectoris
  • Contraindication for moderate to strenuous physical activity

Treatment and study plan

Pedometer Intervention

Behavioral

12 weeks physical activity intervention (supervised/non-supervised)

Pedometer + hospital based intervention

Behavioral

12 weeks physical activity intervention (supervised/non-supervised)

Omron Walking Style pro. 20

Device

Other names: Pedometer

Primary outcomes

  1. Maximum oxygen uptake - ( VO2 peak)

    Time frame: 12 weeks

    Assessed with objective physiological test

Secondary outcomes

  1. Health related Quality of Life

    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

  2. Symptoms and side-effects

    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

  3. Anxiety and Depression

    Time frame: From baseline to 39 weeks

    Assessed by The Hospital Anxiety and Depression Scale

  4. Lifestyle factors

    Time frame: From baseline to 39 weeks

    Assessed by smoking cessation, alcohol, diet

  5. Physical activity level

    Time frame: From baseline to 39 weeks

    Assessed by the International Physical Activity Questionnaire

  6. Dual Energy X-ray Absorptiometry scan

    Time frame: From baseline to 39 weeks

    Assessed by dual energy x-ray absorptiometry.

  7. Blood cholesterols

    Time frame: From baseline to 39 weeks

    Assessed by blood samples

  8. Blood pressure / pulse

    Time frame: From 6 to 12 weeks

    Assessed by Heart Rate Monitor during the hospital-based intervention

  9. Pedometer Step Count

    Time frame: From baseline to 12 weeks

    Assessed by Omron Walking Style pro. 20 with electronic data transmission

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen University Hospital at Herlev
  • Danish Cancer Society
  • Novo Nordisk A/S
  • TrygFonden, Denmark

Registry information

Official study title

Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Aug 13, 2015
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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