The Effect of Floorball on Health and Performance in Subjects With Lifestyle Diseases

May 27, 2019 updated by: Morten Hostrup, PhD, University of Copenhagen

The Effect of Floorball on Health Parameters and Performance in Subjects With Lifestyle Diseases

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • August Krogh Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Floorball
The subjects in this group are set to play floorball three times pr. week for 39 weeks.
Behavioral: Floorball
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.
No Intervention: Control
This group functions as a control group, that will continue the normal lifestyle throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Changes from baseline measured after 12 weeks and 39 weeks
Long term blood sugar concentration
Changes from baseline measured after 12 weeks and 39 weeks
Blood pressure
Time Frame: Changes from baseline measured after 12 weeks and 39 weeks
Changes from baseline measured after 12 weeks and 39 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

May 27, 2019

Study Completion (Anticipated)

June 27, 2020

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Floorball

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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