The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)
April 21, 2016 updated by: University of East Anglia
Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.
Other Names:
|
|
No Intervention: Standard Care
Received usual care.
Was offered the intervention after the completion of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in intention to exercise
Time Frame: 0, 3, 6 months
|
assessed with Intention to exercise scale
|
0, 3, 6 months
|
|
Change in barriers to exercise
Time Frame: 0, 3, 6 months
|
assessed with Barriers to Exercise scale
|
0, 3, 6 months
|
|
Change in physical fitness
Time Frame: 0, 3, and 6 months
|
assessed with the modified Bruce treadmill test
|
0, 3, and 6 months
|
|
Change in upper body strength-grip strength
Time Frame: 0, 3, 6 months
|
Assessed with grip dynanometer
|
0, 3, 6 months
|
|
Change in upper body strength-upper arm strength
Time Frame: 0, 3, 6 months
|
Assessed with biceps curl test
|
0, 3, 6 months
|
|
Change in lower body strength
Time Frame: 0, 3, 6 months
|
Assessed with 30 sec sit-to-stand test
|
0, 3, 6 months
|
|
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in antropometric measures (waist circumference, hip circumference
Time Frame: 0, 3, 6 months
|
Waist and hip circumference will be used to calculate the waist-to-hip ratio
|
0, 3, 6 months
|
|
Changes in anthropometric measures (height, weight, BMI)
Time Frame: 0, 3, 6 months
|
Body weight and body height will be used to calculate BMI
|
0, 3, 6 months
|
|
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John M Saxton, PhD, Northumbria University, Newcastle, United Kingdom
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
April 21, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 26, 2016
Study Record Updates
Last Update Posted (Estimate)
April 26, 2016
Last Update Submitted That Met QC Criteria
April 21, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/EE/0060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.