CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 226 enrolled
Drug / intervention
Interval walking training +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02341690
NCT02341690N/ACompleted

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

University of Copenhagen·interventional·Posted Jan 19, 2015·Updated May 24, 2018

In Brief

A clinical study evaluating Interval walking training and control for Diabetes Mellitus, Type 2. Completed, enrolled 226 participants across 1 site.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 19, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 17, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.5 years ago

Interventions

Interval walking trainingother

Interval Walking Training with the InterWalk Application An Interval-walking bout will consist of repeated cycles of 3 minutes of fast and 3 minutes of slow walking at 70% and 40% of the smart-phone assessed peak VO2-rate, respectively. IWT is conducted for at least 60 minutes per day, three days per week. Compliance is monitored continuously using the on-board accelerometer logger

controlother

Standard care at the promotion centre in the municipality