NCT02366416

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.

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 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable type-2-diabetes-mellitus

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

February 5, 2015

Last Update Submit

April 3, 2018

Conditions

Keywords

Exercise, Physical

Outcome Measures

Primary Outcomes (1)

  • Change of bloodglucose

    HbA1c

    Participants will be followed for a period of 12 weeks physical exercise

Secondary Outcomes (1)

  • Change of musculoskeletal pain

    Participants will be followed for a period of 12 weeks physical exercise

Study Arms (1)

Exercise training

EXPERIMENTAL

12 weeks of one hour exercise training twice weekly

Behavioral: Exercise training

Interventions

Physical activity

Exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 22244365BACKGROUND
  • 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.

    PMID: 21540423BACKGROUND
  • Thomas DE, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD002968. doi: 10.1002/14651858.CD002968.pub2.

    PMID: 16855995BACKGROUND
  • Lebiedz-Odrobina D, Kay J. Rheumatic manifestations of diabetes mellitus. Rheum Dis Clin North Am. 2010 Nov;36(4):681-99. doi: 10.1016/j.rdc.2010.09.008.

    PMID: 21092846BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stig Moelsted, Phd

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 19, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations