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

NCT02089477 | Completed DMC

• 1 other identifier: InterWalk - Validation
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes, InterWalk, Individual Support, Motivation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Frequency of Interval walking with InterWalk

  3 months after enrollment

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

  3 months after enrollment

• validation of InterWalk, VO2-peek test

  3 months after enrollment

• VO2-peek test in the InterWalk Application

  3 months after enrollment

Study Arms (2)

Support

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Support group OTHER

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.

Support

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Laura Staun Valentiner: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Center of Inflammation and Metabolism

Copenhagen, 2200, Denmark

Location

Related Publications (3)

• 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.

  PMID: 30629601 DERIVED

• 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.

  PMID: 28659869 DERIVED

• 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.

  PMID: 28174664 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Mathias Ried-Larsen, Post Doc

  CIM, University Hospital Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD-student

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

DK (1)