Type2 Diabetes, Cardiovascular DiseasesNCT03372005
The Effect of Floorball on Health and Performance in Subjects With Lifestyle Diseases
A study testing Floorball in people with Type2 Diabetes, Cardiovascular Diseases, run by University of Copenhagen at 1 site in Denmark.
Trial summary
To investigate the effect of floorball on health and performance in subjects with either type 2 diabetes or cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Cardiovascular Diseases
- What is being tested?
- Floorball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Sep 2017to 27 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type2 Diabetes, Cardiovascular Diseases
- Being tested
- Floorball
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloorballBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Floorball | Experimental | The subjects in this group are set to play floorball three times pr. week for 39 weeks. Receives: Behavioral: Floorball |
| Control | No intervention | This group functions as a control group, that will continue the normal lifestyle throughout the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Long term blood sugar concentration
Measured: Changes from baseline measured after 12 weeks and 39 weeks
Blood pressure
Measured: Changes from baseline measured after 12 weeks and 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start12 Sep 2017
- Primary completion27 May 2019
- Study completion27 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes, Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372005
- Sponsor's protocol ID
- Floorball
- Status last verified
- May 2019
- First submitted
- 17 Nov 2017
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Floorball on Health Parameters and Performance in Subjects With Lifestyle Diseases
- ClinicalTrials.gov ID
- NCT03372005
- Acronym / sponsor ID
- Floorball
- Conditions
- Type2 Diabetes, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 Jun 2020 (estimated)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of floorball on health and performance in subjects with either type 2 diabetes or cardiovascular diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Floorball | Experimental | Behavioral: FloorballThe subjects in this group are set to play floorball three times pr. week for 39 weeks. |
| Control | No intervention | –This group functions as a control group, that will continue the normal lifestyle throughout the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- age <18 years
- Injuries that prevent the subject from playing floorball
- Type 1 diabetics
- Alcohol >14 units pr. week.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FloorballThis 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. | Behavioural | Floorball |
Primary outcome
HbA1c
Time frame: Changes from baseline measured after 12 weeks and 39 weeks
Long term blood sugar concentration
Blood pressure
Time frame: Changes from baseline measured after 12 weeks and 39 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floorball in people with Type2 Diabetes, Cardiovascular Diseases, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Changes from baseline measured after 12 weeks and 39 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.