NCT05292261

Brief Summary

This study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport. The investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. Moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

March 14, 2022

Last Update Submit

March 28, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Between group differences in peak oxygen uptake at week 16

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

    Week 16

  • Between group differences in peak oxygen uptake at week 36

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

    Week 36

  • Changes from baseline in peak oxygen uptake at week 16

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

    Baseline and week 16

  • Changes from baseline in peak oxygen uptake at week 36

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

    Baseline and week 36

  • Changes from week 16 in peak oxygen uptake at week 36

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

    Week 16 and week 36

Secondary Outcomes (130)

  • Between group differences in resting heart rate at week 16

    Week 16

  • Between group differences in resting heart rate at week 36

    Week 36

  • Changes from baseline in resting heart rate at week 16

    Baseline and week 16

  • Changes from baseline in resting heart rate at week 36

    Baseline and week 36

  • Changes from week 16 in resting heart rate at week 36

    Week 16 and week 36

  • +125 more secondary outcomes

Study Arms (2)

Team handball group

EXPERIMENTAL

The team handball group participants were encouraged to performed at least two out of three weekly supervised team handball training sessions of 60 min each, for 36 weeks.

Other: Recreational team handball

Control group

NO INTERVENTION

The control group participants were instructed to keep their regular daily physical activity for 36 weeks.

Interventions

Two to three weekly sessions of recreational team handball training for 36 weeks. Each 60-min session started with a standardised warm-up (including running, coordination, strength, flexibility, and balance exercises) followed by three 15-min periods of recreational team handball matches, interspersed by 2-min breaks, played as small-sided games (4v4, 5v5 or 6v6). The training sessions were performed on an indoor team handball court (40x20 m) adjusted to result in 34-36 m2 per player. During the matches, the participants rotated positions every 3 min in a random order, including the goalkeeper and no exclusions or substitutions were applied.

Team handball group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years

You may not qualify if:

  • Any medical contraindications to perform moderate-to-vigorous physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maia

Maia, Porto District, 4476-690, Portugal

Location

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 14, 2022

First Posted

March 23, 2022

Study Start

January 2, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations