Condition category
Cancer
Date applied
03/01/2014
Date assigned
20/01/2014
Last edited
20/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Yonsei University College of Medicine (Korea, South )

Sponsor details

c/o Nam Kyu Kim
Department of Surgery
250 Seongsan-ro
Sedaemun-gu
Seoul
120-752
Korea
South

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Research Foundation of Korea (NRF) (No.2010-0009048)

Alternative name(s)

NRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes