NCT03353818

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 21, 2017

Last Update Submit

November 21, 2017

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quality of life

    Evaluated at baseline and after 6 and 12 months

  • Hand muscle strength

    Evaluated at baseline and after 6 and 12 months

  • Diabetic control

    Evaluated at baseline and after 6 and 12 months

  • Adherence

    Evaluated at baseline and after 6 and 12 months

  • Estimated VO2max

    Evaluated at baseline and after 6 and 12 months

Study Arms (2)

Golf

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

No intervention given. No restrictions on physical activity.

Behavioral: No intervention

Interventions

GolfBEHAVIORAL

A free golf course and free membership for one year in a golf club will be given to participants.

Golf
No interventionBEHAVIORAL

Patients acting as controls will not be restricted in any ways.

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Conditions that makes patients unfit for participation in golf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Public Health, Research Unit and Section of General Practice, University of Aarhus, ,

Aarhus, Denmark

Location

Center for Diabetes Research, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

GOLF protocol

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, ph.d.-student

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 27, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)