Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer

NCT02724306 | Completed

• 1 other identifier: 12/EE/0106
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study will use a randomised controlled trial design to investigate whether moderate to vigorous intensity physical activity (MVPA) will affect the physiological risk markers associated with the development of bowel cancer in individuals previously diagnosed with a bowel polyp. The study will also investigate the effects of the programme on long-term exercise behaviour and changes in psychological variables. A selected sample will also be part of individual interviews at baseline and 12 months to gauge narrative accounts of personal, psychological and sociological beliefs surrounding participation in physical activity. The findings of this study might inform better practices for the prevention of bowel cancer in high risk populations. After a screening colonoscopy, eligible participants will be randomised to either an active lifestyle programme (ALP) or a standard care group (SC). Participants in ALP will be offered supervised exercise sessions and motivational interviewing for 6 months. Intervention components will cease after 6 months, but participants will be followed-up at 12 months to investigate maintenance to physical activity over the long-term. The SC will not be offered the intervention until the end of the study. Participants in both groups will be invited for assessments at baseline, 3, 6, 9, and 12 months. These include measurements of body composition, cardiopulmonary fitness, physical activity behaviour, and psycho-social variables.

Conditions

Colon Polyps; Colon Adenomas

Outcome Measures

Primary Outcomes (4)

• Change in DNA methylation in genes associated with inflammation and colon carcinogenesis

  0, 6, 12 months

• Compliance to intervention

  Physical activity diary used to assess compliance

  post-intervention (at 6months)

• Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version

  0, 3, 6, 9,12

• Change in minutes spent in moderate and vigorous intensity leisure activity assessed with the Godin Leisure-Time Exercise Questionnaire

  0, 3, 6, 9, 12

Secondary Outcomes (9)

• Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2

  0, 3, 6, 9, 12 months

• Change in Quality of life measure with the SF-36 questionnaire

  0, 3, 6, 9, 12 months

• Changes in anthropometric measures (height, weight, BMI)

  0, 3, 6, 9, 12 months

• Change in physical fitness

  0, 6, 12 months

• Change in intention to exercise

  0, 3, 6, 9, 12 months

Study Arms (2)

Active Lifestyle Programme

EXPERIMENTAL

ALP will receive supervised exercise sessions twice per week for three months and once per week for the following three months. Participants will also take part in biweekly physical activity workshops for the period of the intervention. Each session consists of a warm-up (5-10min), aerobic (20-30min) and resistance exercises (15-20), and cool-down (5-10)stretches lasting in total 60min. The intensity of exercises will be at 65-85% of maximum heart rate as determined by maximal fitness test. Exercise will take place in small groups of two to five people. Behaviour change workshops to aid the uptake and maintenance of physical activity will be delivered every fortnight throughout the whole intervention period totalling 12 workshops. Workshops will also take place in small groups.

Behavioral: Active Lifestyle Programme

Standard Care

NO INTERVENTION

The standard care group will not be offered the intervention until the end of the study at 12 months. Participants in this group will be encouraged to continue with their usual lifestyle.

Interventions

Active Lifestyle Programme BEHAVIORAL

Active Lifestyle Programme

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of 'intermediate' to 'high' risk as a result of the screening colonoscopy-
• aged 60 years and above
• physically able to partake in regular exercise

You may not qualify if:

• assignment into the 'low risk' category or diagnosis of colorectal cancer following the colonoscopy;
• physical activity levels of at least 150min per week for the last 6 months
• presence or history of other co-morbid conditions which might preclude patients from safely undertaking regular exercise, including cardiovascular or pulmonary disease or stroke
• presence of other colorectal conditions (e.g. inflammatory bowel disease) or known familial colorectal cancer syndrome
• chronic use of any treatments or alternative therapies that may affect the results of any study of colorectal tissue e.g. high corticosteroid, anticoagulant or laxative use, regular enemas, high dose vitamin or antioxidant supplements, etc.;
• previous diagnosis of cancer;
• inability to adequately understand written and spoken English,
• presence of drug controlled type II diabetes mellitus
• current involvement in other ongoing research

Sponsors & Collaborators

• University of East Anglia: lead

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• John M Saxton, PhD

  University of Northumbria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: March 31, 2016
• Study Start: March 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 31, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share