Neuromuscular Adaptations to Exercise In Patients With Ty... | NCT04068285

Studies
Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus

NCT04068285

Sponsor

Pamukkale University

Status

Completed

Last Update Posted

Jun 4, 2020Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Gait, Unsteady
Aerobic Exercise

Interventions

Aerobic Exercise

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2019Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Aug 21, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Aerobic Exercise	Other	Participants will be making aerobic exercise	High intensity interval exercise Moderate intensity continuous exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
walking speed	change in walking speed in m/s	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gulin Findikoglu, Assoc Prof	Pamukkale University,Medical Faculty, PMR Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pamukkale University		Denizli		21600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020233	Gait Disorders, Neurologic
D003924	Diabetes Mellitus, Type 2
D009043	Motor Activity

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided