- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247724
The Health Effects of Small-sided Team Handball
The Physiological Health Effects of 12 Weeks of Small-sided Team Handball Training in Young Adult Women and Men
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active group of men
4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive: *1 group of men playing recreational handball |
|
|
Experimental: Active group of women
4 groups are randomized for 12 weeks of intervention; 2 groups are active, 2 groups are inactive: *1 group of women playing recreational handball |
|
|
Experimental: Inactive group of men
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 |
|
|
Experimental: Inactive group of women
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Measured before and after 12 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat percentage - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Measure of fat percentage (%) performed by a dual energy x-ray absorptiometry (DXA scan)
|
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
|
Measure of muscle mass (kg) performed by a DXA scan
|
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
|
Mineral bone density (g/cm2) performed by a DXA scan
|
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
|
Bone mass (kg) performed by a DXA scan
|
Measured before and after 12 weeks of intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength: Isokinetic Maximal voluntary contraction (MVC) - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Isokinetic MVC (Nm) performed in a isokinetic dynamometer
|
Measured before and after 12 weeks of intervention
|
|
Strength: Isometric MVC - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Isometric MVC (Nm) performed in a isokinetic dynamometer
|
Measured before and after 12 weeks of intervention
|
|
Strength: Countermovement maximal jumps (CMJ) jump height - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
CMJ jump height (cm) performed on a force plate
|
Measured before and after 12 weeks of intervention
|
|
Strength: CMJ jump height - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
CMJ peak (W/kg) performed on a force plate
|
Measured before and after 12 weeks of intervention
|
|
Postural balance: Sway area - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Sway area (cm2) performed on a force plate
|
Measured before and after 12 weeks of intervention
|
|
Postural balance: Sway length - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Sway length (mm) performed on a force plate
|
Measured before and after 12 weeks of intervention
|
|
Citrate synthase (CS) activity - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Muscle biopsies were taken from the male subjects and analyzed for CS activity (ug/l)
|
Measured before and after 12 weeks of intervention
|
|
3-hydroxyacyl-coenzyme A (CoA) dehydrogenase (HAD) activity - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Muscle biopsies were taken from the male subjects and analyzed for HAD activity (ug/l)
|
Measured before and after 12 weeks of intervention
|
|
Specific fibre type cross sectional area (CSA) - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Muscle biopsies were taken from the male subjects and analyzed for specific fibre type CSA (μm2)
|
Measured before and after 12 weeks of intervention
|
|
Fiber type composition - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Muscle biopsies were taken from the male subjects and analyzed for fibre type composition (%)
|
Measured before and after 12 weeks of intervention
|
|
Capillaries (cap./fiber) - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Muscle biopsies were taken from the male subjects and analyzed for cap./fibre
|
Measured before and after 12 weeks of intervention
|
|
Capillaries (cap./mm2) - change is being assessed after 12 weeks of intervention
Time Frame: Measured before and after 12 weeks of intervention
|
Muscle biopsies were taken from the male subjects and analyzed for cap./mm2
|
Measured before and after 12 weeks of intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-15008361
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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