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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089477
• Other study ID #: InterWalk - Validation
• Status: Completed
• Phase: N/A
• First received: March 14, 2014
• Last updated: October 4, 2017
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Support group
The participants in the intervention group receives the intervention and support consisting of: Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week. 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.

Locations

Country	Name	City	State
Denmark	Center of Inflammation and Metabolism	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Laura Staun Valentiner	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is amount of time duing interval walking (in minuts) with InterWalk per week after 3 month		up to 3 months after enrollment
Secondary	Frequency of Interval walking with InterWalk		3 months after enrollment
Secondary	Quality of data with VO2-peek test in the InterWalk Application	quantity of minuts with high and low intervals after 3 month	3 months after enrollment
Secondary	validation of InterWalk, VO2-peek test		3 months after enrollment
Secondary	VO2-peek test in the InterWalk Application		3 months after enrollment