NCT04068285

Brief Summary

The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on basic gait parameters in patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

August 21, 2019

Last Update Submit

June 2, 2020

Conditions

Gait, UnsteadyAerobic Exercise

Keywords

Type 2 diabetes mellitusexerciseaerobicintervalcontinuousgait

Outcome Measures

Primary Outcomes (1)

  • walking speed

    change in walking speed in m/s

    12 weeks

Study Arms (3)

High intensity interval exercise

ACTIVE COMPARATOR

Participants with type 2 Diabetes mellitus in High intensity interval exercise (HIIE) group will make aerobic exercise using bicycle at high intensity followed by low intensity periods under observation in the hospital. exercise

Other: Aerobic Exercise

Moderate intensity continuous exercise

ACTIVE COMPARATOR

Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital. exercise

Other: Aerobic Exercise

No Intervention: Control group

NO INTERVENTION

The participants with type 2 Diabetes mellitus in the control group will make stretching exercise at home

Interventions

Aerobic ExerciseOTHER

Participants will be making aerobic exercise

High intensity interval exerciseModerate intensity continuous exercise

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
  • Participants must have appropriate medical therapy and diet.
  • Participants must not be treated with insulin.
  • Participants must be exercising less than 210 minutes/ week

You may not qualify if:

  • Participants with prominent cardiovascular disease
  • Participants with coronary artery disease
  • Participants with moderate to severe valvular disease
  • Participants with atrial fibrillation
  • Participants with untreated hypertension
  • Participants with congenital heart disease
  • Participants with retinopathy
  • Participants with neuropathy
  • Participants with macro albuminuria
  • Participants with cerebrovascular disease
  • Participants with ejection fraction less than 40
  • Participants with body mass index greater than 35.
  • Participants with prominent ischemic changes in EKG at rest or during exercise.
  • Participants with cigarette or alcohol addiction
  • Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 21600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gait Disorders, NeurologicDiabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gulin Findikoglu, Assoc Prof

    Pamukkale University,Medical Faculty, PMR Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants wil be making exercise. It is not possible to make participants blinded to the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study has 3 arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 28, 2019

Study Start

November 4, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)