The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Active lifestyle programme

• Registration Number: NCT02751892
• Lead Sponsor: University of East Anglia

Brief Summary

Long-term maintenance of physical activity behaviour change post-intervention remains challenging. This study is investigating the feasibility of a behaviour change intervention based on Self-Determination Theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.

Detailed Description

This study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. Participants were allocated to an active lifestyle programme (ALP) or the standard (SC) care group. ALP was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. SC was encouraged to continue with their usual lifestyle. The intervention was informed by Self-Determination Theory.

The supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. Exercise included aerobic and resistance exercises. The behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants.

Participants were followed-up at 6 months. There was no contact with participants during the post-intervention and follow-up period.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-04
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Study First Posted: 2016-04-26
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• a histologically confirmed diagnosis of colorectal cancer with Dukes stages A-C
• completed cancer treatment within the last 24 months,
• be able to understand spoken and written English
• score of 80 or more on the Karnofsky Performance Status Scale

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Exclusion Criteria

• already meeting general PA guidelines of 150 min of moderate PA or 75 min of vigorous intensity PA per week,
• recent myocardial infarction
• uncontrolled hypertension
• a pacemaker
• or unstable angina.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Lifestyle Programme	Active lifestyle programme	Supervised exercises for 3 months and motivational interviewing to facilitate physical activity behaviour change. Supervised exercise sessions took place twice per week for the first four weeks. This was tapered off to once per week for the second four weeks. During the last month of the intervention participants continued with the exercise at home and were encouraged to achieve 150min of moderate to vigorous PA per week.

Primary Outcome Measures

Name	Time	Method
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version	0, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
Change in intention to exercise	0, 3, 6 months	assessed with Intention to exercise scale
Change in quality of life measure with the Functional Assessment of Cancer Therapy general	0, 3, 6 months
Change in antropometric measures (waist circumference, hip circumference	0, 3, 6 months	Waist and hip circumference will be used to calculate the waist-to-hip ratio
Change in physical fitness	0, 3, and 6 months	assessed with the modified Bruce treadmill test
Change in upper body strength-grip strength	0, 3, 6 months	Assessed with grip dynanometer
Change in lower body strength	0, 3, 6 months	Assessed with 30 sec sit-to-stand test
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry	0, 3, 6 months
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale	0, 3, 6 months
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis	0, 3, 6 months
Change in barriers to exercise	0, 3, 6 months	assessed with Barriers to Exercise scale
Change in upper body strength-upper arm strength	0, 3, 6 months	Assessed with biceps curl test
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2	0, 3, 6 months
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal	0, 3, 6 months
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue	0, 3, 6 months
Changes in anthropometric measures (height, weight, BMI)	0, 3, 6 months	Body weight and body height will be used to calculate BMI