Plain English Summary
Background and study aims
Cancer has become a major public health problem in South Korea. Lifestyle factors determine the risk of colorectal cancer and the course of the disease. Studies have shown a strong link between the level of physical activity and the outcomes of colorectal cancer. Although observational studies have shown the link between physical activity and the physical fitness of colorectal cancer patients, there are few interventional studies which have shown these beneficial effects Therefore, the aims of this study are to investigate the effects of a 6-week home-based exercise intervention on cardiovascular and musculoskeletal fitness and patients perceived bowel function in stage II-III colorectal cancer survivors.
Who can participate?
Patients with stage II-III colorectal cancer who have completed all standard cancer-directed therapy at least 4 weeks but no more than 2 years before the study.
What does the study involve?
Patients are randomly allocated to either the exercise group or the control group. Exercise group patients will be encouraged to walk more than 10,000 steps per day. A pedometer will be provided to count the steps. Patients will be provided with exercise DVDs, which consist of 30 minutes exercise using their own body weight, to be performed at home daily. Following each exercise session, participants will complete their exercise log, recording the daily steps, type of exercise and duration. Exercise group participants will visit the clinic three times during the 6 weeks. They will have two exercise education sessions, and the exercise trainer will make sure that patients are able to perform the exercise properly. Control group patients will be instructed to continue with their usual daily activities. The intervention period will be 6 weeks and assessments will be carried out before the start of the study and at 6 weeks.
What are the possible benefits and risks or participating?
All participants will receive exercise DVDs, a pedometer, exercise handouts, and the results of the clinical tests. There are no known risks to participants.
Where is the study run from?
Severance Hospital, Shinchon, Seoul, Korea.
When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between August 2011 and October 2014.
Who if funding the study?
Ministry of Health and Welfare, South Korea.
Who is the main contact?
Professor Justin Jeon
jjeon@yonsei.ac.kr
Trial website
Contact information
Type
Scientific
Primary contact
Prof Justin Jeon
ORCID ID
Contact details
Shinchon-Dong
Seodaemun-Gu
Yonsei University
Seoul
120-749
Korea
South
+82 2 2123 6197
jjeon@yonsei.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of a 6-week home-based exercise program on fitness in colorectal cancer survivors: a randomized controlled trial
Acronym
Study hypothesis
The 6-week exercise intervention program will improve cardiovascular and musculoskeletal fitness and patients perceived bowel function in colorectal cancer survivors.
Ethics approval
Institutional Ethics Review Board at Yonsei University College of Medicine
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stage II to III colorectal cancer survivors
Intervention
Participants will be randomized into either an exercise or usual care group via minimization method.
1. The exercise group will receive a 6-week home-based exercise program. They will be encouraged to walk more than 10,000 steps per day (pedometer will be provided). In addition, patients will be provided with exercise DVDs, which consisted of 30 minutes exercise using their own body weight, to be performed at home daily. Following each exercise session, participants will complete their exercise log, recording the daily steps, type of exercise and duration. Exercise group participants will visit the clinic three times during 6 weeks. They will have two exercise education sessions, and the exercise trainer will make sure that patients are able to perform the exercise properly.
2. Participants in the control group will be instructed to continue with their usual daily activities.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Cardiovascular and musculoskeletal fitness measured by the 3-minute step test and push up test, respectively
2. Patient perceived bowel function measured by questionnaires
Secondary outcome measures
Quality of life measured by the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) scale
Overall trial start date
27/08/2011
Overall trial end date
19/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Between 18 and 75 years of age
2. Histologically confirmed stage II to III colorectal cancer
3. Completed surgery, radiotherapy, and/or chemotherapy within 4-104 weeks prior to the study
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 of 1
5. Not planning extended absences in the 3 months subsequent to enrollment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
56 patients in each group
Participant exclusion criteria
1. Existing evidence of recurrent or metastatic disease
2. Participation in regular physical activity (purposeful activity of at least a moderate intensity of 200 minutes or more a week)
3. Pregnant or planned to be pregnant within 6 months
Recruitment start date
27/08/2011
Recruitment end date
19/10/2014
Locations
Countries of recruitment
Korea, South
Trial participating centre
Shinchon-Dong
Seoul
120-749
Korea, South
Funders
Funder type
Government
Funder name
National Research Foundation of Korea (NRF) (No.2010-0009048)
Alternative name(s)
한국연구재단이 창의적 연구와, NRF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Korea, South
Funder name
Ministry of Health and Welfare, Republic of Korea - National R & D program for Cancer Control (1120230)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list