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Golf and Diabetes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353818
Recruitment Status : Unknown
Verified November 2017 by Alexander Christensen, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Research Unit for General Practice, Aarhus University
Information provided by (Responsible Party):
Alexander Christensen, University Hospital, Gentofte, Copenhagen

Study Description
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Brief Summary:
This a randomised, single-blinded, controlled study that investigate if a free golf training programme will increase the physical activity of type 2 diabetes patients.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: Golf Behavioral: No intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Golf and Diabetes Can an Introctionary Course to Golf and a Free 1-year Membership in a Golf Club Increase Physichal Activity?
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : July 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Golf
In three different golf clubs patients will be introduced how to play golf. They will be taught techniques and recieve basic golf equipment. A total of 1 year membership free membership in the golf clubs will be given.
 Behavioral: Golf
A free golf course and free membership for one year in a golf club will be given to participants.
Placebo Comparator: Placebo
No intervention given. No restrictions on physical activity.
 Behavioral: No intervention
Patients acting as controls will not be restricted in any ways.


Outcome Measures
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Primary Outcome Measures :
  1. Physical activity [ Time Frame: Evaluated at baseline and after 6 and 12 months ]
    Change in physical activity level from baseline to end of study evaluated by 7-days wear of accelerometers.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Evaluated at baseline and after 6 and 12 months ]
    Use of validated questionaries to evaluate impact of quality of life

  2. Hand muscle strength [ Time Frame: Evaluated at baseline and after 6 and 12 months ]
    Change in hand muscle strength

  3. Diabetic control [ Time Frame: Evaluated at baseline and after 6 and 12 months ]
    Changes in diabetes related biochemistry and cardiovascular risk factors

  4. Adherence [ Time Frame: Evaluated at baseline and after 6 and 12 months ]
    Adherence evaluated with diarries

  5. Estimated VO2max [ Time Frame: Evaluated at baseline and after 6 and 12 months ]
    Two point bicycle test, where an estimated VO2 max can be calculated


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2-diabetes
  • Physical activity less than 8000 steps per day
  • Age > 18 years

Exclusion Criteria:

  • Pregnancy
  • Conditions that makes patients unfit for participation in golf
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353818


Locations
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Denmark
Department of Public Health, Research Unit and Section of General Practice, University of Aarhus, ,
Aarhus, Denmark
Center for Diabetes Research, Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Alexander Christensen
Research Unit for General Practice, Aarhus University
More Information
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Responsible Party: Alexander Christensen, MD, ph.d.-student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03353818    
Other Study ID Numbers: H-17001697
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases