Effect of exercise on insulin resistance and adiponectin in colorectal cancer survivors

ISRCTN	ISRCTN47234641
DOI	https://doi.org/10.1186/ISRCTN47234641
Protocol serial number	N/A
Sponsor	Yonsei University College of Medicine (South Korea)
Funders	National Research Foundation of Korea (NRF) (No.2010-0009048), Ministry of Health and Welfare - National R & D program for Cancer Control (Republic of Korea), Ref: 1120230

Submission date: 20/04/2014
Registration date: 30/04/2014
Last edited: 23/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Cancer has become a major public health problem in South Korea. The lifestyle factors are important determinants of colorectal cancer risk. Previous studies have shown a strong association between the level of physical activity and the outcomes of colorectal cancer. However, the effects of exercise on insulin resistance and adipocytokines in colorectal cancer patients still need to be investigated. The aim of this study are to assess the effects of a 12-week home-based exercise intervention on insulin resistance and adiponectin (the hormone produced by fat cells which influences the bodys response to insulin) in colorectal cancer survivors.

Who can participate?
Patients with stage II-III colorectal cancer, who have completed all standard cancer treatment at least 4 weeks earlier but no more than 2 years.

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. They will get exercise DVDs, will record their daily activities and will visit the clinic five times during the 12 weeks. Control group patients will be instructed to continue with their usual daily activities.

What are the possible benefits and risks or participating?
Participants allocated to the exercise group will receive the exercise DVDs, a pedometer, exercise hand outs, and results of clinical tests. There are no known risks to participants.

Where is the study run from?
Severance Hospital, Shinchon, Seoul (South 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 December 2014.

Who is funding the study?
Ministry of Health and Welfare (South Korea)

Who is the main contact?
Professor Justin Jeon
jjeon@yonsei.ac.kr

Contact information

Prof Justin Jeon
Scientific

134 Shinchon-Dong, Seodaemun-Gu, Yonsei University
Seoul
120-749
Korea, South

Email	jjeon@yonsei.ac.kr

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of 12-week home-based exercise program on insulin resistance and adiponectin in colorectal cancer survivors: a randomized controlled trial
Study objectives	The 12-week exercise intervention program will decrease fasting insulin resistance and increase adiponectin in colorectal cancer survivors.
Ethics approval(s)	Institutional Ethics Review Board at Yonsei University College of Medicine
Health condition(s) or problem(s) studied	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 12-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
Primary outcome measure(s)	1. Level of fasting insulin will be measured by a chemiluminescence immunoassay 2. Adiponectin levels will be measured by an enzyme immunoassay kit 3. Insulin resistance will be estimated using the homeostatic model assessment of insulin resistance (HOMA-IR) index
Key secondary outcome measure(s)	1. hs-CRP will be measured by a latex-enhanced immunoturbidimetric assay using an ADNIA 1650 Chemistry system 2. TNF-a levels will be measured using a commercially available enzyme-linked immunosorbent assay 3. Chemerin levels will be measured by an enzyme immunoassay kit 4. Levels of fasting glucose, AST, ALT, GGT, TC, TG, HDL-C will be measured using an ADVIA 1650 Chemistry system 5. Physical fitness measured by the 30minute step test, 6-min walk test, chair stand and push up test 6. Quality of life measured by the FACT-C questionnaires
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	112
Total final enrolment	123
Key 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. ECOG performance status of 0 of 1 5. Not planning extended absences in the 3 months subsequent to enrollment
Key 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 month
Date of first enrolment	27/08/2011
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

Korea, South

Study participating centre

134 Shinchon-Dong, Seodaemun-Gu, Yonsei University

Seoul
120-749
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2017	23/10/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.