NCT03372005

Brief Summary

To investigate the effect of floorball on health and performance in subjects with either type 2 diabetes or cardiovascular diseases.

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
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 12, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2020

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

November 17, 2017

Last Update Submit

May 27, 2019

Conditions

Type2 Diabetes, Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    Long term blood sugar concentration

    Changes from baseline measured after 12 weeks and 39 weeks

  • Blood pressure

    Changes from baseline measured after 12 weeks and 39 weeks

Study Arms (2)

Floorball

EXPERIMENTAL

The subjects in this group are set to play floorball three times pr. week for 39 weeks.

Behavioral: Floorball

Control

NO INTERVENTION

This group functions as a control group, that will continue the normal lifestyle throughout the study.

Interventions

FloorballBEHAVIORAL

This intervention will have one week of testing before the first 12 weeks of floorball, followed by one week of testing before the last 27 week training period.

Floorball

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with type 2 diabetes
  • Diagnosed with a cardiovascular disease (bp \>140/90mmHg)
  • Physical activity \<2 hours pr. week.
  • Not participating in any regular physical activity the last 2 years

You may not qualify if:

  • age \<18 years
  • Injuries that prevent the subject from playing floorball
  • Type 1 diabetics
  • Alcohol \>14 units pr. week.
  • Pregnancy
  • Participation in other scientific studies
  • Abuse of illegal drugs
  • other known serious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 17, 2017

First Posted

December 13, 2017

Study Start

September 12, 2017

Primary Completion

May 27, 2019

Study Completion

June 27, 2020

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations

DK(1)