Clinical trial NCT02089477: The Smart-phone as a Physical Fitness Monitor - Validity, Sensitivity and Motivation InterWalk
Official title: The Smart-phone as a Physical Fitness Monitor on a Population Level - Validity and Sensitivity and Improtance of Individual Motivation for Doing Interval Walking With the InterWalk Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes, InterWalk, Individual Support, Motivation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2014-03-17
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low physical fitness may cause several life style related diseases e.g. cardiovascular disease, cancer and type 2 diabetes. It is important to develop reliable methods for measurement which can be used to follow the development of the physical shape both on an individual level and on at population level.

Associated with the development of new training method known as Interval Walking we developed an application for smartphones. The use of the application InterWalk was meant to increase physical activity in patients with type 2 diabetes. The application should both be able to, 1) be a personal trainer when doing interval walking, and 2) measure the individual physical fitness performed as a walking test. The latter function was developed to make the training more personal and individal adapted, so that the training was neither too hard or too easy.

It is necessary to test the walking test against a golden standard for measuring physical fitness and that the test in the application is able to measure and register changes in physical fitness.

Our hypothesis is that the individual test, in the InterWalk Application is reliable and able to register changes in physical fitness in patients with type 2 diabetes. The purpose of this project is investigate the reliability of a smartphone-based test of physical fitness, and to investigate whether the test is able to register changes in physical fitness during the project time (3 month). A secondary aim is to investigate whether individual support during the training period, affect the individual effort and time of interval walking per week.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, age 30-80 y, BMI \>18 but \<40 kg/m2 and confirmed T2D diagnose

Exclusion Criteria:

* Pregnancy, smoking, contraindication to increased levels of physical activity, insulin dependence, evidence of thyroid, liver, lung, heart or kidney disease

Primary outcomes:
measure: The primary outcome is amount of time duing interval walking (in minuts) with InterWalk per week after 3 month
timeFrame: up to 3 months after enrollment
Secondary outcomes:
measure: Frequency of Interval walking with InterWalk
timeFrame: 3 months after enrollment
measure: Quality of data with VO2-peek test in the InterWalk Application
timeFrame: 3 months after enrollment
measure: validation of InterWalk, VO2-peek test
timeFrame: 3 months after enrollment
measure: VO2-peek test in the InterWalk Application
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center of Inflammation and Metabolism
Study officials:
affiliation: CIM, University Hospital Rigshospitalet
name: Mathias Ried-Larsen, Post Doc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valentiner LS, Thorsen IK, Kongstad MB, Brinklov CF, Larsen RT, Karstoft K, Nielsen JS, Pedersen BK, Langberg H, Ried-Larsen M. Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes-A pilot randomized controlled trial. PLoS One. 2019 Jan 10;14(1):e0208181. doi: 10.1371/journal.pone.0208181. eCollection 2019.
citation: Karstoft K, Brinklov CF, Thorsen IK, Nielsen JS, Ried-Larsen M. Resting Metabolic Rate Does Not Change in Response to Different Types of Training in Subjects with Type 2 Diabetes. Front Endocrinol (Lausanne). 2017 Jun 13;8:132. doi: 10.3389/fendo.2017.00132. eCollection 2017.
citation: Brinklov CF, Thorsen IK, Karstoft K, Brons C, Valentiner L, Langberg H, Vaag AA, Nielsen JS, Pedersen BK, Ried-Larsen M. Criterion validity and reliability of a smartphone delivered sub-maximal fitness test for people with type 2 diabetes. BMC Sports Sci Med Rehabil. 2016 Oct 7;8:31. doi: 10.1186/s13102-016-0056-7. eCollection 2016.