Clinical trial · Interventional
Physical Activity Intervention With People at Increased Risk of Developing Colon Cancer
A Randomised Controlled Trial Investigating the Effect of a 12 Month Active Lifestyle Programme on Physiological Risk Markers and Physical Activity Behaviour in Those Diagnosed With Intermediate or High Risk for Colon Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenomas | — | UNRESOLVED | — |
| Colon Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Lifestyle Programme | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Lifestyle Programme
- description
- 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.
- interventionNames
- Behavioral: Active Lifestyle Programme
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- 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.
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
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