NCT03166852

Brief Summary

High-intensity training (HIT) has showed beneficial effects in type 2 diabetics such as improved glycemic control, improved bloodpressure and more. In addition, HIT is a time-saving training protocol which is of importance, as lack of time often is mentioned as a reason not to train. The combination of the time-saving HIT-protocol and the possibility to train at home and still get feedback on the intensity and amount of training can be appealing for some. This study aims to investigate whether it is possible to train at the right intensity and frequency and only get feedback throug a technology.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

May 23, 2017

Last Update Submit

May 24, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intensity of training

    Is it possible for type 2 diabetics to reach a high intensity on their own?

    Through study completion, an average of 5 weeks

  • Frequency of training

    How often do they train on their own?

    Through study completion, an average of 5 weeks

Secondary Outcomes (3)

  • Diabetes Attitude Score

    At baseline

  • Health Literacy

    At baseline

  • Interview

    At study completion (After 5 weeks of training)

Study Arms (1)

Home-training group

EXPERIMENTAL

High-intensity training at home 3 times/week for 5 weeks

Other: Home-training

Interventions

5 weeks of interval training at home. The training consisted of 3 minutes of warm-up. 10 intervals of 1 minute at 90% of maxHR interspersed with one minute of low intensity pedalling. Cool-down period of 2 minutes.

Home-training group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed type 2 diabetics
  • In possession of a smartphone Approval from own general practitioner

You may not qualify if:

  • Conditions contraindicating high-intensity training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Ole K Hejlesen, Professor

    Medical Informatics, Aalborg University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: One group performs HIT with techology-based feedback for 5 weeks and the next group do the same
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer, PhD-fellow

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 25, 2017

Study Start

April 27, 2016

Primary Completion

November 27, 2016

Study Completion

November 27, 2016

Last Updated

May 25, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share