Golf and Diabetes.

Golf and Diabetes Can an Introctionary Course to Golf and a Free 1-year Membership in a Golf Club Increase Physichal Activity?

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.

Study Overview

• Status: Unknown
• Conditions: Type2 Diabetes
• Intervention / Treatment: Behavioral: Golf; Behavioral: No intervention

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Department of Public Health, Research Unit and Section of General Practice, University of Aarhus, ,
  • Hellerup, Denmark, 2900
    • Center for Diabetes Research, Gentofte Hospital

Participation Criteria

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Use of validated questionaries to evaluate impact of quality of life	Evaluated at baseline and after 6 and 12 months
Hand muscle strength	Change in hand muscle strength	Evaluated at baseline and after 6 and 12 months
Diabetic control	Changes in diabetes related biochemistry and cardiovascular risk factors	Evaluated at baseline and after 6 and 12 months
Adherence	Adherence evaluated with diarries	Evaluated at baseline and after 6 and 12 months
Estimated VO2max	Two point bicycle test, where an estimated VO2 max can be calculated	Evaluated at baseline and after 6 and 12 months

Collaborators and Investigators

• Sponsor: Alexander Christensen
• Collaborators: Research Unit for General Practice, Aarhus University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (ACTUAL): November 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: H-17001697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No