CClinicalTrials.gg
CompletedNCT02089477Updated Oct 5, 2017

The Smart-phone as a Physical Fitness Monitor - Validity, Sensitivity and Motivation InterWalk

An interventional study of Support group in Type 2 Diabetes, sponsored by Laura Staun Valentiner. Completed at 1 site in Denmark. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-05.

Sponsored by Laura Staun Valentiner · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 diabetes, InterWalk, Individual Support, Motivation
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 37 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

This is the only study on the registry with Laura Staun Valentiner as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, smoking, contraindication to increased levels of physical activity, insulin dependence, evidence of thyroid, liver, lung, heart or kidney disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Support

    The participants in the intervention group receives the intervention and support consisting of: 1. Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week. 2. SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking.

    Other: Support group

  • No intervention
    Control group

    Patient's in the control group receives the intervention with interval Walking and no other support.

Interventions

  • OtherSupport group

    The participants in the intervention group receives the intervention and support consisting of: 1. Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week. 2. SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking.

06

What researchers measure

Primary outcomes

  1. The primary outcome is amount of time duing interval walking (in minuts) with InterWalk per week after 3 month

    Time frame: up to 3 months after enrollment

Secondary outcomes

  1. Frequency of Interval walking with InterWalk

    Time frame: 3 months after enrollment

  2. Quality of data with VO2-peek test in the InterWalk Application

    quantity of minuts with high and low intervals after 3 month

    Time frame: 3 months after enrollment

  3. validation of InterWalk, VO2-peek test

    Time frame: 3 months after enrollment

  4. VO2-peek test in the InterWalk Application

    Time frame: 3 months after enrollment

07

Study locations

1 site
  • Center of Inflammation and Metabolism
    Copenhagen, 2200, Denmark
08

References and documents

Publications

  • 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. PubMed 30629601 ↗
  • 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. PubMed 28659869 ↗
  • 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. PubMed 28174664 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02089477
Lead sponsor
Laura Staun Valentiner
Collaborators
Rigshospitalet, Denmark
Responsible party
Laura Staun Valentiner (PhD-student, University of Copenhagen) — Sponsor-investigator
First posted
Mar 17, 2014
Start date
Mar 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Oct 5, 2017

Study contacts

Mathias Ried-Larsen, Post Doc
principal investigator · CIM, University Hospital Rigshospitalet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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