Intervention Study - Effectiveness of Smartphone Delivered Interval Walking Training to Patients With Type 2 Diabetes

NCT02341690 | Completed

• 1 other identifier: INTERWALK
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 Diabetes (T2D) is one of the most common chronic diseases world vide. Patients with T2D experiences reduced quality of life and have a lower physical activity level. Physical activity is well documented treatment to the patient group. The effect of physical activity is shown to reduce co-morbidity, and better functional level and quality of life. Interval Walking Training (IWT) is a new and effective exercise type. IWT is done by walking in a slow and a fast tempo. InterWalk is an application to a smartphone. By using InterWalk the patient can to IWT independently and when used, the app has, as an exercise tool, the potential to better the individual functional level and to measure the physical activity level with the integrated personalised walking test. Motivation for change of habits and lifestyle is subjectively determined by the individual, his or hers individual resources and environment. It is important to get insight in these individual challenges in order to be better structure possible help. The combination of an exercise log, a measure of physical activity fromInterWalk and insight in motivational aspects on an individual level, is essential for successful individualised training. The primary objective of the study is to investigate if the InterWalk app is more effective in increasing the physical activity level compared to a standard care offer in a sample of newly T2D diabetes patients across 52 weeks. Secondarily, we will investigate if the IW app can reduce sitting time, induce weight loss, improve glycaemic control, increase quality of life, improve cardio-respiratory fitness and reduce the use of diabetes medication. The study is designed to test the hypothesis that replacing a standard exercise program in the normal municipal standard care with the Interval Walking Training delivered by the IW app with and without a motivational support program, can increase the long-term physical activity level in patients with T2D for a period of 52 weeks. From January 2015 to June 2016 all patient's with T2D, who are referred to the promotion centres in the municipality, will be offered to participate in the study. In total 513 patients with T2D from different municipalities in Denmark will be included and randomly allocated into three groups. One group will receive standard care and the two other groups will do IWT with the InterWalk app. All three groups are followed by the promotion centre for 8-14 weeks (according to the rehabilitation in the municipality) and hereafter only one of the IWT groups will receive motivational support up to 52 weeks. All patients, no mater group allocation, will be tested and fulfill questionnaires, three times during the intervention period - at baseline, after 8-14 weeks and after 52 weeks. The interventions take place at the promotion centres in the municipalities two times a week and the patient will be encouraged train by them selves one time a week.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes; Interval Walking Training; Motivation

Outcome Measures

Primary Outcomes (1)

• Changes in Physical activity from baseline to 52 weeks, measured with accelerometrics

  Physical activity is measured with accelerometrics, where the patient wear two accelerometers (one on the thigh and one on the back) for 7 days at home, at baseline, after 8-14 weeks (according to the muncipality) and after 52 weeks.

  52 weeks

Secondary Outcomes (6)

• Changes in VO2-peak from baseline to 52 weeks, measured by the standardised walking test (in the InterWalk)

  52 weeks

• Change in Endurance in the lower extremities from baseline to 52 weeks, measured by sit-to-stand (30 seconds)

  January 2015 to July 2017

• Changes in Self-rated physical activity from baseline to 52 weeks, measured by "The Resent Physical Activity Questionnaire" (RPAQ)

  52 weeks

• Changes in Health related quality of life from baseline to 52 weeks, measured by SF-12

  52 weeks

• Changes in Motivation for physical activity and behaviour change from baseline to 52 weeks, measured by the Behavioural exercise regulation questionnaire (BREQ-2).

  52 weeks

Other Outcomes (2)

• Exploratory secondary outcome - Personality (measured once at baseline), measured by the NEO-Five Factor Inventory (NEO-FFI) and a Sensation Seeking Scale (SES).

  12 weeks

• Changes in physical activity habits and diabetic motivation from baseline to 52 weeks - patients will be asked to answer 4 questions regarding their physical activity habits

  52 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard rehabilitation with exercise

Other: control

Intervention (Interval Walking Training)

EXPERIMENTAL

Interval Walking Training with the InterWalk app, 3 times per week, 60 min. per sessions for 52 weeks. The intervention period is divided into 1. a period that follows standard care in the municipality (from 8-14 weeks according to the municipality. 2. a period (from week 8-14 to week 52) the patients will do Interval Walking on their own. 3. After the intervention at the promotion centre (8-14 weeks), the intervention group will be divided into to groups - a Interval Walking group (IWT) and a Interval Walking group with support (IWTsupport). IWTsupport: Patients in this group (after intervention at the promotion centre) will in addition to the IWT receive motivational support from week 8-14 to week 52 by the health professionals at the promotion centre.

Other: Interval walking training

Interventions

Interval walking training OTHER

Interval Walking Training with the InterWalk Application An Interval-walking bout will consist of repeated cycles of 3 minutes of fast and 3 minutes of slow walking at 70% and 40% of the smart-phone assessed peak VO2-rate, respectively. IWT is conducted for at least 60 minutes per day, three days per week. Compliance is monitored continuously using the on-board accelerometer logger

Intervention (Interval Walking Training)

control OTHER

Standard care at the promotion centre in the municipality

Control

Eligibility Criteria

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

You may qualify if:

• Patients are eligible if they are diagnosed with T2D and are more than 18 years of age.

You may not qualify if:

• Medical contraindications to exercise e.g. if the patient has developed chronic complications in the locomotive apparatus, e.g. painful osteoarthritis or heart conditions (30,39) and already is participating in other studies at the promotion centres concerning PA.

Sponsors & Collaborators

• University of Copenhagen: lead
• Center for Physical Activity Research (CFAS): collaborator
• The Danish Center for Strategic Research on Type 2 Diabetes: collaborator
• The Danish Diabetes Association: collaborator
• The Parker Institute, Department of Rheumatology, Copenhagen University Hospital at Bispebjerg and Frederiksberg.: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, 1014, Denmark

Location

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  BACKGROUND

• Thorsen IK, Yang Y, Valentiner LS, Glumer C, Karstoft K, Brond JC, Nielsen RO, Brons C, Christensen R, Nielsen JS, Vaag AA, Pedersen BK, Langberg H, Ried-Larsen M. The Effects of a Lifestyle Intervention Supported by the InterWalk Smartphone App on Increasing Physical Activity Among Persons With Type 2 Diabetes: Parallel-Group, Randomized Trial. JMIR Mhealth Uhealth. 2022 Sep 28;10(9):e30602. doi: 10.2196/30602.

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura S Valentiner

  University of Copenhagen

  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: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 19, 2015
• Study Start: January 1, 2015
• Primary Completion: December 17, 2017
• Study Completion: December 17, 2017
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

DK (1)