NCT02340260

Brief Summary

Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but few patients exercise according to guidelines. In this study the effect of two time efficient high intensity exercise protocols on glycemic control and other cardiometabolic risk factors are investigated in patients with type 2 diabetes.The investigators assume that glycemic control is improved more by low-volume high intensity interval training than by extremely low-volume sprint interval training.

Trial Health

87
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 Aug 2013

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

January 7, 2015

Last Update Submit

June 13, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

ExerciseRisk factorsExercise therapyHemoglobin A, Glycosylated

Outcome Measures

Primary Outcomes (1)

  • Glycosylated hemoglobin (HbA1c)

    12 weeks

Study Arms (2)

High intensity interval training

OTHER

High intensity interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 10x1-minute intervals at 90 % of HRmax, with 75 seconds of active recovery at 70 % of HRmax between each interval. Exercise is completed with a three minute cool down. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention.

Behavioral: High intensity interval training

Sprint interval training

OTHER

Sprint interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 2x20 seconds of maximum intensity intervals, with 3 minutes and 20 seconds of active recovery at 70 % of HRmax between each interval, followed by 3 minutes cooling down at the same intensity. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention.

Behavioral: Sprint interval training

Interventions

High intensity interval trainingBEHAVIORAL

High intensity exercise during 12 weeks with three weekly training sessions

High intensity interval training
Sprint interval trainingBEHAVIORAL

Sprint interval exercise during 12 weeks with three weekly training sessions

Sprint interval training

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20-65 years
  • diagnosed with type 2 diabetes within the past 10 years
  • no use of insulin.

You may not qualify if:

  • known cardiovascular disease- or lung disease, coronary artery disease
  • untreated hypertension of ≥140/90 mmHg
  • orthopaedic or neurological restrictions
  • severe obesity (BMI ≥35)
  • pregnancy
  • unability to exercise
  • drug- or alcohol abuse
  • reluctance to sign the consent form
  • more reported physical active than recommended in current exercise guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Circulation and Medical Imaging, NTNU

Trondheim, Norway

Location

Related Publications (1)

  • Revdal A, Hollekim-Strand SM, Ingul CB. Can Time Efficient Exercise Improve Cardiometabolic Risk Factors in Type 2 Diabetes? A Pilot Study. J Sports Sci Med. 2016 May 23;15(2):308-13. eCollection 2016 Jun.

    PMID: 27274669RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Toril A Nagelhus Hernes, prof

    Department Circulation and Medical Imaging, NTNU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 16, 2015

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

NO(1)