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临床试验/NCT02751892
NCT02751892已完成不适用

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

University of East Anglia0 个研究点目标入组 28 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
主要终点
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version

时间窗: 0, 3, 6 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

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