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

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ClinicalTrials.gov Identifier: NCT02089477
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Laura Staun Valentiner, University of Copenhagen

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Support group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 [ Time Frame: 3 months after enrollment ]
    quantity of minuts with high and low intervals after 3 month

  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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089477


Locations
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Denmark
Center of Inflammation and Metabolism
Copenhagen, Denmark, 2200
Sponsors and Collaborators
Laura Staun Valentiner
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Mathias Ried-Larsen, Post Doc CIM, University Hospital Rigshospitalet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laura Staun Valentiner, PhD-student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02089477    
Other Study ID Numbers: InterWalk - Validation
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Keywords provided by Laura Staun Valentiner, University of Copenhagen:
Type 2 diabetes, InterWalk, Individual Support, Motivation
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases