The Effectiveness of Smartphone Delivered Interval Walking Training on Physical Activity and Glycemic Control in Patients With Type 2 Diabetes: a Pragmatic Randomized Controlled Trial - Part of The InterWalk Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Changes in Physical activity from baseline to 52 weeks, measured with accelerometrics
研究概览
简要总结
Type 2 Diabetes (T2D) is one of the most common chronic diseases world vide. Patients with T2D experiences reduced quality of life and have a lower physical activity level. Physical activity is well documented treatment to the patient group. The effect of physical activity is shown to reduce co-morbidity, and better functional level and quality of life.
Interval Walking Training (IWT) is a new and effective exercise type. IWT is done by walking in a slow and a fast tempo. InterWalk is an application to a smartphone. By using InterWalk the patient can to IWT independently and when used, the app has, as an exercise tool, the potential to better the individual functional level and to measure the physical activity level with the integrated personalised walking test.
Motivation for change of habits and lifestyle is subjectively determined by the individual, his or hers individual resources and environment. It is important to get insight in these individual challenges in order to be better structure possible help.
The combination of an exercise log, a measure of physical activity fromInterWalk and insight in motivational aspects on an individual level, is essential for successful individualised training.
The primary objective of the study is to investigate if the InterWalk app is more effective in increasing the physical activity level compared to a standard care offer in a sample of newly T2D diabetes patients across 52 weeks.
Secondarily, we will investigate if the IW app can reduce sitting time, induce weight loss, improve glycaemic control, increase quality of life, improve cardio-respiratory fitness and reduce the use of diabetes medication.
The study is designed to test the hypothesis that replacing a standard exercise program in the normal municipal standard care with the Interval Walking Training delivered by the IW app with and without a motivational support program, can increase the long-term physical activity level in patients with T2D for a period of 52 weeks.
From January 2015 to June 2016 all patient's with T2D, who are referred to the promotion centres in the municipality, will be offered to participate in the study. In total 513 patients with T2D from different municipalities in Denmark will be included and randomly allocated into three groups. One group will receive standard care and the two other groups will do IWT with the InterWalk app. All three groups are followed by the promotion centre for 8-14 weeks (according to the rehabilitation in the municipality) and hereafter only one of the IWT groups will receive motivational support up to 52 weeks.
All patients, no mater group allocation, will be tested and fulfill questionnaires, three times during the intervention period - at baseline, after 8-14 weeks and after 52 weeks. The interventions take place at the promotion centres in the municipalities two times a week and the patient will be encouraged train by them selves one time a week.
详细描述
Background Type 2 diabetes (T2D) is one of the most common long-term medical conditions worldwide. The patients have a two-fold increased mortality rate compared to the general population T2D is a major problem in Denmark and the incidence is estimated to rise from 280.000 today to approximately 500.000 people by 2020 (5).
The T2D rehabilitation program in the Danish municipalities has the overall purpose of introducing and helping patients to a healthier lifestyle (6). The program is conducted in a period of 8-14 week with some or no exercise intervention, with no long-term follow-up. Not much is known on the amount and integration of PA in the patient's everyday life following the intervention (7). This major variation across municipalities poses a problem in the rehabilitation of TD2, as the quality of rehabilitation depends on the geographical location of the T2D patient.
Several studies have shown that supervised PA is advantageous; in patients with T2D on key metabolic factors (6-9) and that it improves quality of life and reduces the risk of all-cause mortality (1,2,6,10,11,12). Due to the many beneficial effects of PA on T2D patients, PA is an important factor in the prevention and treatment of T2D (13). Long-term PA interventions have employed supervised exercise regimes (14,15) that are effective, but also demanding and expensive. Attempts to increase the daily physical activity level on a large scale, in a free-living "real life", have very little effect (14-16) despite well-established patient education programs. In general, the exercise adherence is low and dropout rates are high in this group of patients. A large number of patients with T2D experience diminished quality of life, decreased physical functioning, diminished exercise tolerance (17), numerous patients are unmotivated or incapable to change behaviour and the prevalence of depressive and anxiety symptoms are highly prevalent in T2D patients (17,18,19). Collectively this could pose important barriers to engagement in exercise and reaching the recommended level of PA (20).
Karstoft et al (2013) examined the feasibility of implementing a free-living interval walking (IWT) and continuous walking training program in a smaller sample of patients with T2D. IWT was initiated and monitored by a Japanese training device, the JD-mate (10). The study found remarkable effects on physical fitness level, body composition and glycaemic control and with a compliance rate of more than 85% and a very low dropout level (9). Based on the experiences by Karstoft et al and several pilot testing's in the Danish Diabetes Association (DF), we believe that IWT can be an approach to handle lack of PA in patients with T2D. However the JD-mate, is expensive (3500 kr.), Japanese instructions, lacks automatic transmission of data and is thus not user-friendly on a larger scale. It is evident that novel low cost, more sustainable exercise solutions and suitable vehicle are needed and through this, improve quality of life and increase life expectancy in these patients.
The use of Tele-Health interventions (THI) have the potential to educate and engage patients with T2D in self-management in the long-term and the evidence suggests that THI could be effective and feasible in improving clinical outcomes in diabetes care (14,15,22,23). The widespread and increasing use of smartphone applications is opening new ways to improve health and health care delivery. It might be ideal to use THI to increase physical activity and hereby target a large part of the population by simple and inexpensive means. The smartphone has been used as a tool among others to register exercise, diet, weight and plasma glucose levels, but the evidence of using a smartphone as an exercise device is lacking (24).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible if they are diagnosed with T2D and are more than 18 years of age.
排除标准
- •Medical contraindications to exercise e.g. if the patient has developed chronic complications in the locomotive apparatus, e.g. painful osteoarthritis or heart conditions (30,39) and already is participating in other studies at the promotion centres concerning PA.
研究组 & 干预措施
Control
Standard rehabilitation with exercise
干预措施: control (Other)
Intervention (Interval Walking Training)
Interval Walking Training with the InterWalk app, 3 times per week, 60 min. per sessions for 52 weeks. The intervention period is divided into
- a period that follows standard care in the municipality (from 8-14 weeks according to the municipality.
- a period (from week 8-14 to week 52) the patients will do Interval Walking on their own.
- After the intervention at the promotion centre (8-14 weeks), the intervention group will be divided into to groups - a Interval Walking group (IWT) and a Interval Walking group with support (IWTsupport).
IWTsupport: Patients in this group (after intervention at the promotion centre) will in addition to the IWT receive motivational support from week 8-14 to week 52 by the health professionals at the promotion centre.
干预措施: Interval walking training (Other)
结局指标
主要结局
Changes in Physical activity from baseline to 52 weeks, measured with accelerometrics
时间窗: 52 weeks
Physical activity is measured with accelerometrics, where the patient wear two accelerometers (one on the thigh and one on the back) for 7 days at home, at baseline, after 8-14 weeks (according to the muncipality) and after 52 weeks.
次要结局
- Changes in VO2-peak from baseline to 52 weeks, measured by the standardised walking test (in the InterWalk)(52 weeks)
- Change in Endurance in the lower extremities from baseline to 52 weeks, measured by sit-to-stand (30 seconds)(January 2015 to July 2017)
- Changes in Self-rated physical activity from baseline to 52 weeks, measured by "The Resent Physical Activity Questionnaire" (RPAQ)(52 weeks)
- Changes in Health related quality of life from baseline to 52 weeks, measured by SF-12(52 weeks)
- Changes in Motivation for physical activity and behaviour change from baseline to 52 weeks, measured by the Behavioural exercise regulation questionnaire (BREQ-2).(52 weeks)
- Body temperature, measured by an ear thermometer(52 weeks)
研究者
Laura Staun Valentiner
PhD-student
University of Copenhagen