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临床试验/NCT02064335
NCT02064335已完成不适用

Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年2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
48
试验地点
2
主要终点
Weight

研究概览

简要总结

In this project the investigators like to develop a methodology to stimulate more physical activity in inactive diabetic persons by an adapted physical activity program. An individually oriented and medically adapted exercise plan will be set up. Participants will be stimulated to be physically active in the long term, even when the coaching has been finished.

In a randomized controlled trial the health effects of the coaching are studied in the short and long term. This trial, in addition to a process evaluation by all stakeholders, gives more information about the implementation of the project in Flanders.

详细描述

Being physically active on a regular base makes part of a healthy lifestyle. Research has shown several positive effects of physical activity on physical and mental health. This is also the case in diabetic persons, who are more vulnerable for certain diseases (e.g. cardiovascular diseases).

However, a lot of people are not interested and motivated to participate in the local exercise activities. The offer often does not satisfy the different needs of those subjects or the barriers for participating are too high. Diabetic persons are also confronted with these problems. However, physical activity is an important part in the treatment of the disease. There is an urgent need for accessible physical activity programs which motivate diabetic persons to adapt a healthy lifestyle, in the short and long term.

A physical activity coach can set up a physical activity plan, individually adapted and according to the medical needs of a diabetic person. This program is created, based on the principles of need supportive coaching.

In this project the researchers will investigate the effects of an individually adapted physical activity plan on health and behavior in diabetic persons. The focus of this project will be on the tertiary prevention. For the recruitment of the subjects, there will be a collaboration with a health insurance company in Belgium (CM).

Communication: Possible participants (cfr database CM) will receive a letter with the invitation of an information session. This information session handles about the importance of being physically active enough in diabetic persons and will present the project where participants are guided by a physical activity coach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • In this project, we aim for inactive diabetic subjects. Persons who have more than 30 minutes of moderate exercise a day, will be excluded

结局指标

主要结局

Weight

时间窗: Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)

Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write weight

Psychological parameters

时间窗: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)

Psychological parameters are determined by psychological questionnaires. The researchers will investigate motivation, well being, self-efficacy and social support.

Blood pressure

时间窗: change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)

Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write blood pressure

HbA1c

时间窗: change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)

Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write down HbA1C value, taken by a blood sample

Sedentary behavior

时间窗: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)

Subjective sedentary behavior is determined by a questionnaire.

Physical activity

时间窗: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)

Level of physical activity is determined by means of an objective physical activity monitor which has to be carried on the upper arm for 1 week.

Physical fitness

时间窗: change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)

Physical fitness is determined by means of the 6 minutes walking test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Filip Boen

Doctor, Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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