HealthyNCT04247724
The Health Effects of Small-sided Team Handball
A study testing Recreational handball in people with Healthy, run by University of Copenhagen.
Trial summary
The purpose of the project was to examine the fitness and health effects of participation in recreational Team Handball for untrained 20-30 year old healthy men and women. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Recreational handball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 1 Jul 2016
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women and men from 20-30 years old
- If women, a regular menstrual cycle length (25 to 32 days) with or without use of contraceptives.
Who cannot join
- Known familiar diseases
- If been smoking for the last two years before recruitment
- If involved in any regular physical training two years before recruitment
- Women: a peak oxygen uptake (VO2peak) higher than 45 mL/min/kg
- Men: a peak oxygen uptake (VO2peak) higher than 51 mL/min/kg
About this study
Official title: The Physiological Health Effects of 12 Weeks of Small-sided Team Handball Training in Young Adult Women and Men
The purpose of the project was to examine the fitness and health effects of participation in recreational Team Handball for untrained 20-30 year old healthy men and women.
Read the detailed description
Fitness and health effects of 12 weeks of recreational team handball in untrained adult men and women aged 20-30 years"
Adult men and women aged 20-30 years will be recruited to take part in a 12-week intervention with recreational team handball. Half of the participants are men (n=32), who are randomly assigned to a group playing recreational team handball (n=16) and an inactive control group (n=16). The women (n=40) are also divided and assigned to a group with regular participation in recreational team handball (n=20) and an inactive control group (n=20). The training sessions will be offered 2-3 times weekly for 70 minutes per session by a supervised trainer. The sessions involves an injury preventive warm-up and ball exercises for 15 minutes followed by recreational handball on small pitches such as 4 vs 4. A comprehensive testing protocol is conducted before and after the training period. The measurements includes body composition and bone mineralization, blood pressure, resting heart rate, fasting blood sugar, insulin, cholesterol and bone markers. In addition, a number of physical tests which involves fitness level (VO2max), intermittent work, muscle strength and balance will further be conducted. The testing takes place at the University of Copenhagen. The training sessions will also take place at the University of Copenhagen or in a handball club near the University. The study will be approved by the local ethical committee of Copenhagen.
- Conditions
- Healthy
- Being tested
- Recreational handball, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreational handballBehavioural
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Active group of men | Experimental | 4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive:
*1 group of men playing recreational handball Receives: Behavioral: Recreational handball |
| Active group of women | Experimental | 4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive:
*1 group of women playing recreational handball Receives: Behavioral: Recreational handball |
| Inactive group of men | Experimental | 4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive:
*1 group of men continuing their normal lifestyle patterns Receives: Behavioral: Control |
| Inactive group of women | Experimental | 4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive:
*1 group of women continuing their normal lifestyle patterns Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max - change is being assessed after 12 weeks of intervention
VO2max (mL/kg/min) is a measure of the cardiorespiratory during a treadmill test
Measured: Measured before and after 12 weeks of intervention
Secondary outcomes (4)
Fat percentage - change is being assessed after 12 weeks of intervention
Measure of fat percentage (%) performed by a dual energy x-ray absorptiometry (DXA scan)
Measured: Measured before and after 12 weeks of intervention
Muscle mass - change is being assessed after 12 weeks of intervention
Measure of muscle mass (kg) performed by a DXA scan
Measured: Measured before and after 12 weeks of intervention
Mineral bone density - change is being assessed after 12 weeks of intervention
Mineral bone density (g/cm2) performed by a DXA scan
Measured: Measured before and after 12 weeks of intervention
Bone mass - change is being assessed after 12 weeks of intervention
Bone mass (kg) performed by a DXA scan
Measured: Measured before and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Aug 2015
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247724
- Sponsor's protocol ID
- H-15008361
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fristrup B, Krustrup P, Andersen JL, Hornstrup T, Lowenstein FT, Larsen MA, Helge JW, Povoas SCA, Aagaard P. Effects of small-sided recreational team handball training on mechanical muscle function, body composition and bone mineralization in untrained young adults-A randomized controlled trial. PLoS One. 2020 Nov 18;15(11):e0241359. doi: 10.1371/journal.pone.0241359. eCollection 2020.
PubMed 33206670
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Health Effects of 12 Weeks of Small-sided Team Handball Training in Young Adult Women and Men
- ClinicalTrials.gov ID
- NCT04247724
- Acronym / sponsor ID
- H-15008361
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 30 Jan 2020 (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.
The purpose of the project was to examine the fitness and health effects of participation in recreational Team Handball for untrained 20-30 year old healthy men and women.
Detailed description
Fitness and health effects of 12 weeks of recreational team handball in untrained adult men and women aged 20-30 years"
Adult men and women aged 20-30 years will be recruited to take part in a 12-week intervention with recreational team handball. Half of the participants are men (n=32), who are randomly assigned to a group playing recreational team handball (n=16) and an inactive control group (n=16). The women (n=40) are also divided and assigned to a group with regular participation in recreational team handball (n=20) and an inactive control group (n=20). The training sessions will be offered 2-3 times weekly for 70 minutes per session by a supervised trainer. The sessions involves an injury preventive warm-up and ball exercises for 15 minutes followed by recreational handball on small pitches such as 4 vs 4. A comprehensive testing protocol is conducted before and after the training period. The measurements includes body composition and bone mineralization, blood pressure, resting heart rate, fasting blood sugar, insulin, cholesterol and bone markers. In addition, a number of physical tests which involves fitness level (VO2max), intermittent work, muscle strength and balance will further be conducted. The testing takes place at the University of Copenhagen. The training sessions will also take place at the University of Copenhagen or in a handball club near the University. The study will be approved by the local ethical committee of Copenhagen.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active group of men | Experimental | Behavioral: Recreational handball4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive: *1 group of men playing recreational handball |
| Active group of women | Experimental | Behavioral: Recreational handball4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive: *1 group of women playing recreational handball |
| Inactive group of men | Experimental | Behavioral: Control4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive: *1 group of men continuing their normal lifestyle patterns |
| Inactive group of women | Experimental | Behavioral: Control4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive: *1 group of women continuing their normal lifestyle patterns |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women and men from 20-30 years old
- If women, a regular menstrual cycle length (25 to 32 days) with or without use of contraceptives.
Key exclusion criteria (5 listed)
- Known familiar diseases
- If been smoking for the last two years before recruitment
- If involved in any regular physical training two years before recruitment
- Women: a peak oxygen uptake (VO2peak) higher than 45 mL/min/kg
- Men: a peak oxygen uptake (VO2peak) higher than 51 mL/min/kg
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 |
|---|---|---|
| Recreational handball | Behavioural | Active group of men, Active group of women |
| Control | Behavioural | Inactive group of men, Inactive group of women |
Primary outcome
VO2max - change is being assessed after 12 weeks of intervention
Time frame: Measured before and after 12 weeks of intervention
VO2max (mL/kg/min) is a measure of the cardiorespiratory during a treadmill test
4 secondary outcomes
Fat percentage - change is being assessed after 12 weeks of intervention
Time frame: Measured before and after 12 weeks of intervention
Muscle mass - change is being assessed after 12 weeks of intervention
Time frame: Measured before and after 12 weeks of intervention
Mineral bone density - change is being assessed after 12 weeks of intervention
Time frame: Measured before and after 12 weeks of intervention
Bone mass - change is being assessed after 12 weeks of intervention
Time frame: Measured before and after 12 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 33206670Fristrup B, Krustrup P, Andersen JL, Hornstrup T, Lowenstein FT, Larsen MA, Helge JW, Povoas SCA, Aagaard P. Effects of small-sided recreational team handball training on mechanical muscle function, body composition and bone mineralization in untrained young adults-A randomized controlled trial. PLoS One. 2020 Nov 18;15(11):e0241359. doi: 10.1371/journal.pone.0241359. eCollection 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Recreational handball in people with Healthy, run by University of Copenhagen.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VO2max - change is being assessed after 12 weeks of intervention (time frame: Measured before and after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04247724, which also lists 1 linked publication.
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 30 Jan 2020.