Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus

NCT ID: NCT04068285

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-06-01

Brief Summary

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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.

Detailed Description

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Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with basic gait parameters such as cadence, gait speed, stride length, percentages of swing phase and stance phase evaluated by a wireless digital miniature gait analysis system.

Conditions

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Gait, Unsteady Aerobic Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study has 3 arms.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Participants wil be making exercise. It is not possible to make participants blinded to the study.

Study Groups

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High intensity interval exercise

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

Group Type ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type OTHER

Participants will be making aerobic exercise

Moderate intensity continuous exercise

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

Group Type ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type OTHER

Participants will be making aerobic exercise

No Intervention: Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercise

Participants will be making aerobic exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Participants with prominent cardiovascular disease
2. Participants with coronary artery disease
3. Participants with moderate to severe valvular disease
4. Participants with atrial fibrillation
5. Participants with untreated hypertension
6. Participants with congenital heart disease
7. Participants with retinopathy
8. Participants with neuropathy
9. Participants with macro albuminuria
10. Participants with cerebrovascular disease
11. Participants with ejection fraction less than 40
12. Participants with body mass index greater than 35.
13. Participants with prominent ischemic changes in EKG at rest or during exercise.
14. Participants with cigarette or alcohol addiction
15. Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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GULIN FINDIKOGLU

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gulin Findikoglu, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University,Medical Faculty, PMR Department

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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60116787-0

Identifier Type: -

Identifier Source: org_study_id

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