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Trial registered on ANZCTR


Registration number
ACTRN12615000908538
Ethics application status
Approved
Date submitted
19/08/2015
Date registered
1/09/2015
Date last updated
1/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of high-intensity compared with moderate-intensity exercise training on the health of colorectal cancer survivors: a randomised controlled trial
Scientific title
The influence of high-intensity compared with moderate-intensity exercise training on the insulin-like growth factor axis, cardiorespiratory fitness, body composition and psychosocial health in colorectal cancer survivors: a randomised controlled trial
Secondary ID [1] 287302 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 295937 0
Cancer survivorship 295938 0
Condition category
Condition code
Cancer 296202 296202 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 296206 296206 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will investigate the feasibility and efficacy of high intensity exercise (HIE) as compared with moderate intensity exercise (MIE) on the insulin-like growth factor (IGF) axis, cardiorespiratory fitness, body composition and psychosocial health in colorectal cancer survivors.

Study Design:
This study is a three-arm, 12 week randomised controlled trial.

Participants:
Men and women who have been previously treated for colorectal cancer will be invited to participate in this randomised clinical trial.

Intervention Structure:
Following recruitment, participants will complete a familiarisation session, before which they will be provided with further details of the research program and afforded the opportunity to seek clarification for any questions related to the study. At the commencement of this session informed consent will be attained by way of a written consent form, witnessed by the principle investigator. The familiarisation session will conclude with a test of peak oxygen consumption (VO2peak test) After familiarisation, participants will complete a baseline testing session to measure all primary and secondary outcomes. Participants will then be randomised to one of three groups: (1) high intensity exercise - continuous (HIE-C) training group; (2) high intensity exercise - tapered (HIE-T) training group;(3) or a moderate intensity exercise (MIE) training group.

The HIE-C and MIE groups will train at a frequency of 3 times per week for 8 weeks whereas the HIE-T group will train at a frequency of 3 times per week for the first 4 weeks, and at a frequency of once per week for the later 4 weeks. Participants will undergo testing at baseline (0 weeks), midpoint (4 weeks), endpoint (8 weeks) and follow-up (12 weeks). All exercise testing and training sessions will be supervised by an Accredited Exercise Physiologist (Exercise and Sports Science Australia). Participants will exercise in groups ranging from 1 to 4 depending on the suitability of times for each individual participant.

Intervention:
The HIE sessions will commence with 10 minutes of warm up at 50-70% of peak heart rate (HRpeak) before commencing 4 x 4 minute bouts of cycling at 85-95% HRpeak. Each 4 minute interval will be interspersed with a 3 minute period of active recovery at 50-70% HRpeak, totalling 38 minutes for the session. Attendance will be measured via a training log, and adherence to the prescribed exercise will be asssessed by continuous heart rate monitoring.
Intervention code [1] 292622 0
Lifestyle
Intervention code [2] 292623 0
Rehabilitation
Intervention code [3] 292683 0
Treatment: Other
Comparator / control treatment
MIE has been implemented as a comparator 'usual care group' for this intervention. The MIE training protocol will consist of 50 minutes of cycling at 50-70% HRpeak. The frequency and volume of MIE was established according to current physical activity guidelines recommended for cancer survivors and for adults by the American College of Sports Medicine for adults (150 minutes of moderate intensity physical activity per week).
Control group
Active

Outcomes
Primary outcome [1] 295877 0
Insulin-like growth factor (IGF)-1, analysed using a commercially available plasma enzyme linked immunosorbent assay (ELISA)
Timepoint [1] 295877 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Primary outcome [2] 295937 0
IGF binding protein (IGFBP) - 3, analysed using a commercially available plasma ELISA
Timepoint [2] 295937 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Primary outcome [3] 295938 0
IGF-2, analysed using a commercially available plasma ELISA
Timepoint [3] 295938 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [1] 316795 0
IGFBP-1, analysed using a commercially available plasma ELISA (primary)
Timepoint [1] 316795 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [2] 316796 0
IGFBP-2, analysed using a commercially available plasma ELISA (primary)
Timepoint [2] 316796 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [3] 316797 0
interleukin-8, analysed using a commercially available plasma ELISA (primary)
Timepoint [3] 316797 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [4] 316798 0
Insulin, measured via electrochemiluminescence plasma immunoassay (primary)
Timepoint [4] 316798 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [5] 316964 0
Glucose, measured via electrochemiluminescence plasma immunoassay (primary)
Timepoint [5] 316964 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [6] 316965 0
Insulin sensitivity (derived from an oral glucose tolerance test)(primary)
Timepoint [6] 316965 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [7] 316967 0
Cardiorespiratory fitness (VO2peak) (as measured by a cardiopulmonary exercise test using a cycle ergometer)
Timepoint [7] 316967 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [8] 316968 0
Body composition: body mass, fat mass, fat free mass, body fat percentage (as measured by dual energy x-ray absorptiometry)
Timepoint [8] 316968 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [9] 316969 0
Quality of life: Functional assessment of cancer therapy: colorectal (FACT-C)
Timepoint [9] 316969 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [10] 316970 0
Fatigue: Functional assessment of cancer therapy - fatigue (FACT-F)
Timepoint [10] 316970 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks); Follow-up (12 weeks)
Secondary outcome [11] 316971 0
Program safety: Program safety will be assessed by the number and degree of adverse events during the intervention. Adverse events are defined as ‘any untoward medical occurrence in a participant subject to the intervention’. A severe adverse event is defined as any event requiring hospitalisation or causing an inability to carry out usual activities. Adverse events will be assessed by monitoring and recording during all exercise sessions by the supervising Exercise Physiologist.

Exercise testing and training can result in mild discomfort, delayed onset of muscle soreness (DOMS) and joint stiffness especially in untrained individuals. However, participants will be informed of the possibility of DOMS, symptoms and procedures to alleviate them. Warm-ups and cool-downs will be incorporated in each testing and training session to reduce muscle soreness and return the individual to their resting level before leaving the testing facility. There is also the very low risk of a muscle strain however this risk will be greatly reduced by careful monitoring of each participant and requiring a warm-up and cool-down period with each exercise session.
Timepoint [11] 316971 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks)
Secondary outcome [12] 316972 0
Program feasibility: Program feasibility will be assessed by measuring rates of intervention completion, rates of attendance as measured by a training log, adherence to the prescribed exercise intensity as measured by continuous heart rate monitoring and enjoyment as measured by the Physical Activity Enjoyment Scale (PACES).
Timepoint [12] 316972 0
Baseline (0 weeks); Midpoint (4 weeks); Endpoint (8 weeks)

Eligibility
Key inclusion criteria
i. Aged over 18 years old.
ii. Greater than or equal to one-month post-treatment for colorectal cancer.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Medicated with insulin or any insulin sensitising agents (biguanides, thiazolidinediones, sulfonylureas or meglitinides).
ii. Any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study as determined by the research team and the participant's primary healthcare physician.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be contacted either through access to the population based Queensland Cancer Registry according to previously described procedures or from an existing cohort of colorectal cancer survivors. Participants are required to obtain physician consent for participation in the program, and are individually screened via a medical history form and interview with the investigators to determine eligibility. Written informed consent will be obtained from all subjects prior to commencing the study. Randomisation will occur following baseline testing off-site and as such is concealed from the principle investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher independent to the study stratified the participants according to age (less than 55 or greater than or equal to 55 years) and sex and then randomised them via a computer-based random number generating process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size calculations were performed to determine the number of participants required for this trial at an alpha of 0.05 and power (1 – beta) of 0.80. Calculations indicated that to detect a change in IGF-1 of 22.0 ng/ml with a pooled standard deviation (SD) of 25.2 ng/ml from pre-intervention to post-intervention and with an anticipated 20% attrition rate based on previous studies, 23 participants per group should meet the minimum power required to detect a significant difference between pre- and post-training.

Data will be analysed using the SPSS statistical software package (version 22.0, SPSS, Inc., Chicago, IL). Analyses will include standard descriptive statistics, t tests, correlation, regression and two-way repeated measures ANOVA or the comparable non-parametric test as necessary to examine differences between and within groups, from baseline, week 4, 8 and 12.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291865 0
University
Name [1] 291865 0
The University of Queensland
Address [1] 291865 0
School of Human Movement and Nutrition Sciences
The Unviersity of Queensland
St Lucia, QLD, 4072
Country [1] 291865 0
Australia
Funding source category [2] 291866 0
Government body
Name [2] 291866 0
Queensland Health (Remserv)
Address [2] 291866 0
Queensland Health Building
147-163 Charlotte Street
Brisbane Queensland 4000 Australia
Country [2] 291866 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Human Movement and Nutrition Sciences
The Unviersity of Queensland
St Lucia, 4072
Country
Australia
Secondary sponsor category [1] 290530 0
Charities/Societies/Foundations
Name [1] 290530 0
Cancer Council Queensland
Address [1] 290530 0
553 Gregory Terrace
Fortitude Valley QLD 4006
Country [1] 290530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293375 0
University of Queensland Human Ethics Committee
Ethics committee address [1] 293375 0
UQ Research & Innovation
Cumbrae-Stewart Building (72)
University of Queensland QLD 4072
Ethics committee country [1] 293375 0
Australia
Date submitted for ethics approval [1] 293375 0
Approval date [1] 293375 0
17/07/2013
Ethics approval number [1] 293375 0
2013000749

Summary
Brief summary
Overview:
The primary purpose of this study is to investigate the effect of moderate (MIE) as compared with high intensity exercise (HIE) on a number of outcomes related to the health of colorectal cancer survivors.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over, and have finished treatment for colorectal cancer at least one month prior.

Study details:
Participants, will undertake baseline testing including a fitness test, blood sampling, a body composition scan and questionnaires. Participants will then be randomly allocated (by chance) to one of three exercise programs for 8 weeks. Exercise sessions will last approximately 40-50 minutes and be carried out 1-3 times per week, depending on the program allocated. The exercise will be in the form of stationary cycling. Patient outcomes will then be assessed through further fitness testing, blood sampling, body scan and questionnaires at 4 weeks into the program, at the end of the 8 week program and 4 weeks after the end of the exercise program. This study will be used to inform exercise prescription recommendations to enhance prognosis following colorectal cancer diagnosis and treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59618 0
Mr James Devin
Address 59618 0
Room 241
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 59618 0
Australia
Phone 59618 0
(+61) 7 3365 6240
Fax 59618 0
Email 59618 0
j.devin@uq.edu.au
Contact person for public queries
Name 59619 0
Mr James Devin
Address 59619 0
Room 241
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 59619 0
Australia
Phone 59619 0
(+61) 7 3365 6240
Fax 59619 0
Email 59619 0
j.devin@uq.edu.au
Contact person for scientific queries
Name 59620 0
Mr James Devin
Address 59620 0
Room 241
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 59620 0
Australia
Phone 59620 0
(+61) 7 3365 6240
Fax 59620 0
Email 59620 0
j.devin@uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results