NCT05295511

Brief Summary

The present study aims at analyzing the dose-response effects of a recreational team handball-based exercise programme on cardiovascular, metabolic, musculoskeletal and physical fitness markers of inactive middle-aged and older men, without previous experience with the sport. The researchers hypothesized a positive weekly training frequency effect on health and physical fitness outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

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

December 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

March 15, 2022

Last Update Submit

March 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in maximal oxygen uptake

    Maximal oxygen uptake (mL/min/kg) was measured by pulmonary gas exchange measurements. The participants performed an incremental treadmill test until voluntary exhaustion in a laboratory, according to a standardized incremental protocol.

    Baseline and week 16

Secondary Outcomes (46)

  • Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in systolic blood pressure

    Baseline and week 16

  • Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in diastolic blood pressure

    Baseline and week 16

  • Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in resting heart rate

    Baseline and week 16

  • Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body mass

    Baseline and week 16

  • Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm total mass

    Baseline and week 16

  • +41 more secondary outcomes

Study Arms (4)

Team Handball 1

EXPERIMENTAL

Team handball group participants were instructed to perform one weekly 60-min recreational team handball training sessions for 16 weeks.

Other: Recreational Team Handball programme

Team Handball 2

EXPERIMENTAL

Team handball group participants were instructed to perform two weekly 60-min recreational team handball training sessions for 16 weeks.

Other: Recreational Team Handball programme

Team Handball 3

EXPERIMENTAL

Team handball group participants were instructed to perform three weekly 60-min recreational team handball training sessions for 16 weeks.

Other: Recreational Team Handball programme

Control Group

NO INTERVENTION

The control group participants were instructed to keep their regular daily physical activity for 16 weeks.

Interventions

All training sessions consisted of a standardized 15-min warm-up (running, coordination, strength, flexibility and balance exercises), followed by 3x15-min periods of recreational team handball matches interspersed by 2-min breaks, performed in an indoor team handball court. The matches were played as small and formal game formats (4v4, 5v5, 6v6 or 7v7).

Team Handball 1Team Handball 2Team Handball 3

Eligibility Criteria

Age50 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMiddle-aged and older men
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male participants; inactive with 50 or more years of age (i.e., not complying with the physical activity guidelines for the last 6 months).

You may not qualify if:

  • Any medical contraindication to perform moderate-to-vigorous physical activity; incapacity to run or grip a ball.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity of Maia

Maia, Porto District, 4475-690, Portugal

Location

Related Publications (2)

  • Carneiro I, Krustrup P, Castagna C, Pereira R, Jorgensen NR, Coelho E, Povoas S. Bone health, body composition and physical fitness dose-response effects of 16 weeks of recreational team handball for inactive middle-to-older-aged males - A randomised controlled trial. Eur J Sport Sci. 2023 Nov;23(11):2251-2263. doi: 10.1080/17461391.2023.2222685. Epub 2023 Jul 10.

  • Carneiro I, Krustrup P, Castagna C, Mohr M, Magalhaes J, Pereira R, Santos R, Martins S, Guimaraes JT, Coelho E, Povoas S. Dose-response effect of a recreational team handball-based exercise programme on cardiometabolic health and physical fitness in inactive middle-aged-to-elderly males - a randomised controlled trial. Eur J Sport Sci. 2023 Nov;23(11):2178-2190. doi: 10.1080/17461391.2023.2213195. Epub 2023 Jul 19.

Study Officials

  • Susana Póvoas

    University of Maia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 25, 2022

Study Start

December 1, 2017

Primary Completion

July 12, 2019

Study Completion

July 12, 2019

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations