NCT04247724

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

January 20, 2020

Last Update Submit

January 27, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 before and after 12 weeks of intervention

Secondary Outcomes (4)

  • Fat percentage - change is being assessed after 12 weeks of intervention

    Measured before and after 12 weeks of intervention

  • Muscle mass - change is being assessed after 12 weeks of intervention

    Measured before and after 12 weeks of intervention

  • Mineral bone density - change is being assessed after 12 weeks of intervention

    Measured before and after 12 weeks of intervention

  • Bone mass - change is being assessed after 12 weeks of intervention

    Measured before and after 12 weeks of intervention

Other Outcomes (12)

  • Strength: Isokinetic Maximal voluntary contraction (MVC) - change is being assessed after 12 weeks of intervention

    Measured before and after 12 weeks of intervention

  • Strength: Isometric MVC - change is being assessed after 12 weeks of intervention

    Measured before and after 12 weeks of intervention

  • Strength: Countermovement maximal jumps (CMJ) jump height - change is being assessed after 12 weeks of intervention

    Measured before and after 12 weeks of intervention

  • +9 more other outcomes

Study Arms (4)

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

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

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

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

Behavioral: Control

Interventions

Recreational handballBEHAVIORAL
Active group of menActive group of women
ControlBEHAVIORAL
Inactive group of menInactive group of women

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33206670DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Therese Hornstrup Bondebjerg

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 30, 2020

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 30, 2020

Record last verified: 2020-01