The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02751892|
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Active lifestyle programme||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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.
Behavioral: Active lifestyle programme
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 Name: MOVE
No Intervention: Standard Care
Received usual care. Was offered the intervention after the completion of the study.
- 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 ]
- Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2 [ Time Frame: 0, 3, 6 months ]
- Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale [ Time Frame: 0, 3, 6 months ]
- Change in quality of life measure with the Functional Assessment of Cancer Therapy general [ Time Frame: 0, 3, 6 months ]
- Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal [ Time Frame: 0, 3, 6 months ]
- Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue [ Time Frame: 0, 3, 6 months ]
- Change in intention to exercise [ Time Frame: 0, 3, 6 months ]assessed with Intention to exercise scale
- Change in barriers to exercise [ Time Frame: 0, 3, 6 months ]assessed with Barriers to Exercise scale
- Change in physical fitness [ Time Frame: 0, 3, and 6 months ]assessed with the modified Bruce treadmill test
- Change in upper body strength-grip strength [ Time Frame: 0, 3, 6 months ]Assessed with grip dynanometer
- Change in upper body strength-upper arm strength [ Time Frame: 0, 3, 6 months ]Assessed with biceps curl test
- Change in lower body strength [ Time Frame: 0, 3, 6 months ]Assessed with 30 sec sit-to-stand test
- Changes in body composition (% body fat) assessed with bioelectrical impedance analysis [ Time Frame: 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
- Changes in anthropometric measures (height, weight, BMI) [ Time Frame: 0, 3, 6 months ]Body weight and body height will be used to calculate BMI
- Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry [ Time Frame: 0, 3, 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751892
|Principal Investigator:||John M Saxton, PhD||Northumbria University, Newcastle, United Kingdom|