Effects of Physical Exercise on Blood Glucose and Pain Fr... | NCT02366416

Studies
Effects of Physical Exercise on Blood Glucose and Pain From the Musculoskeletal System in Patients With Type 2 Diabetes

NCT02366416

Sponsor

Nordsjaellands Hospital

Status

Completed

Last Update Posted

Apr 5, 2018Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus

Interventions

Exercise training

Countries

Denmark

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

Apr 2018

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

Apr 2015Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Feb 5, 2015

First Submission Date that Met QC Criteria

Feb 11, 2015

First Posted Date

Feb 19, 2015Estimated

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

Apr 3, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 investigate the effects og physical exercise on bloodglucose and pain from the musculoskeletal system in patients with type 2 diabetes.

The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients will be stratified to patients with a high or a low degree of complications related to diabetes.

Detailed Description

Design: Uncontrolled intervention study Patients: Type 2 diabetes from Nordsjællands Hospital, Denmark Inclusion critera: adults, type 2 diabetes, not participating in an ungoing exercise program, able to conduct exercise training Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia Intervention: two times one hour exercise training for 12 week. The training will be combined aerobic and resistance training supervised by physiotherapists Outcome: bloodglucose, pain (questionaire) Sample size: 80 participants

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
Exercise training	Experimental	12 weeks of one hour exercise training twice weekly	Behavioral: Exercise training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training	Behavioral	Physical activity	Exercise training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of bloodglucose	HbA1c	Participants will be followed for a period of 12 weeks physical exercise

Secondary Outcomes

Measure	Description	Time Frame
Change of musculoskeletal pain	Questionaire	Participants will be followed for a period of 12 weeks physical exercise

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Type 2 diabetes
Must be able to perform physical exercise

Exclusion Criteria:

Participation in structured exercise program within the past three months
Dementia
Unable to understand Danish language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stig Moelsted, Phd	Nordsjaellands Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nordsjællands Hospital		Hillerød		3400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22244365	Background	Molsted S, Tribler J, Snorgaard O. Musculoskeletal pain in patients with type 2 diabetes. Diabetes Res Clin Pract. 2012 May;96(2):135-40. doi: 10.1016/j.diabres.2011.12.022. Epub 2012 Jan 12.
21540423	Background	Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.

ID	Term
D003924	Diabetes Mellitus, Type 2
D009043	Motor Activity

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

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