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Completed

NCT Number: NCT02751892

The Feasibility of an Active Lifestyle Programme in 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Lifestyle Programme

Behavioral

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: MOVE

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Registry information

Official study title

Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer

Acronym: MOVE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 26, 2016
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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