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

April 3, 2018 updated by: Nordsjaellands Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise training
12 weeks of one hour exercise training twice weekly
Behavioral: Exercise training
Physical activity

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Investigators

  • Principal Investigator: Stig Moelsted, Phd, Nordsjællands Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2014-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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