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Clinical Trials/NCT02751892
NCT02751892
Completed
Not Applicable

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

University of East Anglia0 sites28 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
University of East Anglia
Enrollment
28
Primary Endpoint
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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

  • 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)
  • Change in physical fitness(0, 3, and 6 months)
  • Change in upper body strength-grip strength(0, 3, 6 months)
  • Change in lower body strength(0, 3, 6 months)
  • 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)
  • Change in upper body strength-upper arm strength(0, 3, 6 months)
  • 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)
  • Change in intention to exercise(0, 3, 6 months)
  • Changes in anthropometric measures (height, weight, BMI)(0, 3, 6 months)

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