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

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ClinicalTrials.gov Identifier: NCT02751892
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Active lifestyle programme Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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.
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2 [ Time Frame: 0, 3, 6 months ]
  2. Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale [ Time Frame: 0, 3, 6 months ]
  3. Change in quality of life measure with the Functional Assessment of Cancer Therapy general [ Time Frame: 0, 3, 6 months ]
  4. Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal [ Time Frame: 0, 3, 6 months ]
  5. Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue [ Time Frame: 0, 3, 6 months ]
  6. Change in intention to exercise [ Time Frame: 0, 3, 6 months ]
    assessed with Intention to exercise scale

  7. Change in barriers to exercise [ Time Frame: 0, 3, 6 months ]
    assessed with Barriers to Exercise scale

  8. Change in physical fitness [ Time Frame: 0, 3, and 6 months ]
    assessed with the modified Bruce treadmill test

  9. Change in upper body strength-grip strength [ Time Frame: 0, 3, 6 months ]
    Assessed with grip dynanometer

  10. Change in upper body strength-upper arm strength [ Time Frame: 0, 3, 6 months ]
    Assessed with biceps curl test

  11. Change in lower body strength [ Time Frame: 0, 3, 6 months ]
    Assessed with 30 sec sit-to-stand test

  12. Changes in body composition (% body fat) assessed with bioelectrical impedance analysis [ Time Frame: 0, 3, 6 months ]
  13. 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

  14. Changes in anthropometric measures (height, weight, BMI) [ Time Frame: 0, 3, 6 months ]
    Body weight and body height will be used to calculate BMI

  15. Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry [ Time Frame: 0, 3, 6 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of East Anglia
Investigators
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Principal Investigator: John M Saxton, PhD Northumbria University, Newcastle, United Kingdom

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Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT02751892     History of Changes
Other Study ID Numbers: 13/EE/0060
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases