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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03353818
Other study ID # H-17001697
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 21, 2017
Last updated November 21, 2017
Start date May 1, 2017
Est. completion date July 1, 2018

Study information

Verified date November 2017
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date July 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Golf
A free golf course and free membership for one year in a golf club will be given to participants.
No intervention
Patients acting as controls will not be restricted in any ways.

Locations

Country Name City State
Denmark Department of Public Health, Research Unit and Section of General Practice, University of Aarhus, , Aarhus
Denmark Center for Diabetes Research, Gentofte Hospital Hellerup

Sponsors (2)

Lead Sponsor Collaborator
Alexander Christensen Research Unit for General Practice, Aarhus University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity Change in physical activity level from baseline to end of study evaluated by 7-days wear of accelerometers. Evaluated at baseline and after 6 and 12 months
Secondary Quality of life Use of validated questionaries to evaluate impact of quality of life Evaluated at baseline and after 6 and 12 months
Secondary Hand muscle strength Change in hand muscle strength Evaluated at baseline and after 6 and 12 months
Secondary Diabetic control Changes in diabetes related biochemistry and cardiovascular risk factors Evaluated at baseline and after 6 and 12 months
Secondary Adherence Adherence evaluated with diarries Evaluated at baseline and after 6 and 12 months
Secondary Estimated VO2max Two point bicycle test, where an estimated VO2 max can be calculated Evaluated at baseline and after 6 and 12 months
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