- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03371238
Effect of Floorball on Healthy Subjects
May 27, 2019 updated by: Morten Hostrup, PhD, University of Copenhagen
The Effect of Floorball on Health and Performance Parameters in Healthy Seniors
To investigate the effect of floorball on health and performance in healthy subjects over 65 years.
Study Overview
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
-
-
-
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
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- age 65-85
- physical activity <2 hours pr. week.
Exclusion Criteria:
- age <18 years
- Injuries that prevent the subject from playing floorball
- Alcohol >14 units pr. week.
- Pregnancy
- Other serious conditions
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 |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Floorball
|
The subjects in this group are set to play floorball three times pr.
week for 39 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Echocardiogram
Time Frame: Changes from baseline measured after 12 weeks and 39 weeks
|
The measure of the hearts geometric dimensions
|
Changes from baseline measured after 12 weeks and 39 weeks
|
|
Bodycomposition
Time Frame: Changes from baseline measured after 12 weeks and 39 weeks
|
DXA scan
|
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
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 14, 2017
Primary Completion (Actual)
May 27, 2019
Study Completion (Anticipated)
June 1, 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
Other Study ID Numbers
- MFloorball
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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