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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Copenhagen
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Laura Staun Valentiner, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT02089477
First received: March 14, 2014
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Other: Support group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of Interval walking with InterWalk [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
  • Quality of data with VO2-peek test in the InterWalk Application [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    quantity of minuts with high and low intervals after 3 month

  • validation of InterWalk, VO2-peek test [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
  • VO2-peek test in the InterWalk Application [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes, age 30-70 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089477

Contacts
Contact: Laura Staun Valentiner, PhD-student +45 51173649 lauravalentiner@gmail.com
Contact: Mathias Ried-Larsen, Post Doc +45 21782087 mathias.ried-larsen@regionh.dk

Locations
Denmark
Center of Inflammation and Metabolism Recruiting
Copenhagen, Denmark, 2200
Contact: Laura Staun Valentiner, PhD-student    +45 51173649    lauravalentiner@gmail.com   
Contact: Mathias Ried-Larsen, Post Doc    +45 21782087    mathias.ried-larsen@regionh.dk   
Sub-Investigator: Cecilie Brinkløv, PhD-student         
Principal Investigator: Mathias Ried-Larsen, Post Doc         
Sub-Investigator: Laura Staun Valentiner, PhD-student         
Sponsors and Collaborators
Laura Staun Valentiner
Rigshospitalet, Denmark
Investigators
Principal Investigator: Mathias Ried-Larsen, Post Doc CIM, University Hospital Rigshospitalet
  More Information

No publications provided

Responsible Party: Laura Staun Valentiner, PhD-student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02089477     History of Changes
Other Study ID Numbers: InterWalk - Validation
Study First Received: March 14, 2014
Last Updated: March 18, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by University of Copenhagen:
Type 2 diabetes, InterWalk, Individual Support, Motivation

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014