MenopauseH4HWNCT05292261
Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women
A study testing Recreational team handball in people with Menopause, run by University Institute of Maia at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Recreational team handball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2016to 1 Mar 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years
Who cannot join
- Any medical contraindications to perform moderate-to-vigorous physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women
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).
- Conditions
- Menopause
- Being tested
- Recreational team handball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreational team handballOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Recreational team handball |
| Control group | No intervention | The control group participants were instructed to keep their regular daily physical activity for 36 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group differences in peak oxygen uptake at week 16
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 16 and week 36
Secondary outcomes (130)
Between group differences in resting heart rate at week 16
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Measured: Week 16
Between group differences in resting heart rate at week 36
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Measured: Week 36
Changes from baseline in resting heart rate at week 16
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Measured: Baseline and week 16
Changes from baseline in resting heart rate at week 36
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Measured: Baseline and week 36
Changes from week 16 in resting heart rate at week 36
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Measured: Week 16 and week 36
Between group differences in body mass at week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 16
Between group differences in body mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 36
Changes from baseline in body mass at week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Baseline and week 16
Changes from baseline in body mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in body mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 16 and week 36
Between group differences in fat mass at week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 16
Between group differences in fat mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 36
Changes from baseline in fat mass at week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Baseline and week 16
Changes from baseline in fat mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in fat mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 16 and week 36
Between group differences in lean mass at week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 16
Between group differences in lean mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 36
Changes from baseline in lean mass at week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Baseline and week 16
Changes from baseline in lean mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in lean mass at week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Measured: Week 16 and week 36
Between group differences in lumbar spine bone mineral density at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16
Between group differences in lumbar spine bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 36
Changes from baseline in lumbar spine bone mineral density at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Changes from baseline in lumbar spine bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in lumbar spine bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16 and week 36
Between group differences in dominant femur bone mineral density at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16
Between group differences in dominant femur bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 36
Changes from baseline in dominant femur bone mineral density at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Changes from baseline in dominant femur bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in dominant femur bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16 and week 36
Between group differences in dominant femoral neck bone mineral density at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16
Between group differences in dominant femoral neck bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 36
Changes from baseline in dominant femoral neck bone mineral density at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Changes from baseline in dominant femoral neck bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in dominant femoral neck bone mineral density at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16 and week 36
Between group differences in lumbar spine bone mineral content at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16
Between group differences in lumbar spine bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 36
Changes from baseline in lumbar spine bone mineral content at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Changes from baseline in lumbar spine bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in lumbar spine bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16 and week 36
Between group differences in dominant femur bone mineral content at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16
Between group differences in dominant femur bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 36
Changes from baseline in dominant femur bone mineral content at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Changes from baseline in dominant femur bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in dominant femur bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16 and week 36
Between group differences in dominant femoral neck bone mineral content at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16
Between group differences in dominant femoral neck bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 36
Changes from baseline in dominant femoral neck bone mineral content at week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Changes from baseline in dominant femoral neck bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 36
Changes from week 16 in dominant femoral neck bone mineral content at week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Week 16 and week 36
Between group differences in osteocalcin at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16
Between group differences in osteocalcin at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 36
Changes from baseline in osteocalcin at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Changes from baseline in osteocalcin at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 36
Changes from week 16 in osteocalcin at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16 and week 36
Between group differences in procollagen type-1 amino-terminal propeptide at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16
Between group differences in procollagen type-1 amino-terminal propeptide at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 36
Changes from baseline in procollagen type-1 amino-terminal propeptide at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 36
Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16 and week 36
Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16
Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 36
Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 36
Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16 and week 36
Between group differences in sclerostin at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16
Between group differences in sclerostin at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 36
Changes from baseline in sclerostin at week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Changes from baseline in sclerostin at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 36
Changes from week 16 in sclerostin at week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Measured: Week 16 and week 36
Between group differences in isometric knee extension peak torque at week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Week 16
Between group differences in isometric knee extension peak torque at week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Week 36
Changes from baseline in isometric knee extension peak torque at week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Baseline and week 16
Changes from baseline in isometric knee extension peak torque at week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Baseline and week 36
Changes from week 16 in isometric knee extension peak torque at week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Week 16 and week 36
Between group differences in isometric knee extension rate of force development at week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Week 16
Between group differences in isometric knee extension rate of force development at week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Week 36
Changes from baseline in isometric knee extension rate of force development at week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Baseline and week 16
Changes from baseline in isometric knee extension rate of force development at week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Baseline and week 36
Changes from week 16 in isometric knee extension rate of force development at week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Measured: Week 16 and week 36
Between group differences in upper body strength at week 16
Determined by a handgrip dynamometer.
Measured: Week 16
Between group differences in upper body strength at week 36
Determined by a handgrip dynamometer.
Measured: Week 36
Changes from baseline in upper body strength at week 16
Determined by a handgrip dynamometer.
Measured: Baseline and week 16
Changes from baseline in upper body strength at week 36
Determined by a handgrip dynamometer.
Measured: Baseline and week 36
Changes from week 16 in upper body strength at week 36
Determined by a handgrip dynamometer.
Measured: Week 16 and week 36
Between group differences in postural balance at week 16
Determined by the number of falls in a single-legged flamingo balance test.
Measured: Week 16
Between group differences in postural balance at week 36
Determined by the number of falls in a single-legged flamingo balance test.
Measured: Week 36
Changes from baseline in postural balance at week 16
Determined by the number of falls in a single-legged flamingo balance test.
Measured: Baseline and week 16
Changes from baseline in postural balance at week 36
Determined by the number of falls in a single-legged flamingo balance test.
Measured: Baseline and week 36
Changes from week 16 in postural balance at week 36
Determined by the number of falls in a single-legged flamingo balance test.
Measured: Week 16 and week 36
Between group differences in aerobic performance at week 16
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Measured: Week 16
Between group differences in aerobic performance at week 36
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Measured: Week 36
Changes from baseline in aerobic performance at week 16
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Measured: Baseline and week 16
Changes from baseline in aerobic performance at week 36
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Measured: Baseline and week 36
Changes from week 16 in aerobic performance at week 36
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Measured: Week 16 and week 36
Between group differences in total cholesterol at week 16
Determined by an automated analyser.
Measured: Week 16
Between group differences in total cholesterol at week 36
Determined by an automated analyser.
Measured: Week 36
Changes from baseline in total cholesterol at week 16
Determined by an automated analyser.
Measured: Baseline and week 16
Changes from baseline in total cholesterol at week 36
Determined by an automated analyser.
Measured: Baseline and week 36
Changes from week 16 in total cholesterol at week 36
Determined by an automated analyser.
Measured: Week 16 and week 36
Between group differences in high-density lipoprotein cholesterol at week 16
Determined by an automated analyser.
Measured: Week 16
Between group differences in high-density lipoprotein cholesterol at week 36
Determined by an automated analyser.
Measured: Week 36
Changes from baseline in high-density lipoprotein cholesterol at week 16
Determined by an automated analyser.
Measured: Baseline and week 16
Changes from baseline in high-density lipoprotein cholesterol at week 36
Determined by an automated analyser.
Measured: Baseline and week 36
Changes from week 16 in high-density lipoprotein cholesterol at week 36
Determined by an automated analyser.
Measured: Week 16 and week 36
Between group differences in low-density lipoprotein cholesterol at week 16
Determined by an automated analyser.
Measured: Week 16
Between group differences in low-density lipoprotein cholesterol at week 36
Determined by an automated analyser.
Measured: Week 36
Changes from baseline in low-density lipoprotein cholesterol at week 16
Determined by an automated analyser.
Measured: Baseline and week 16
Changes from baseline in low-density lipoprotein cholesterol at week 36
Determined by an automated analyser.
Measured: Baseline and week 36
Changes from week 16 in low-density lipoprotein cholesterol at week 36
Determined by an automated analyser.
Measured: Week 16 and week 36
Between group differences in triglycerides at week 16
Determined by an automated analyser.
Measured: Week 16
Between group differences in triglycerides at week 36
Determined by an automated analyser.
Measured: Week 36
Changes from baseline in triglycerides at week 16
Determined by an automated analyser.
Measured: Baseline and week 16
Changes from baseline in triglycerides at week 36
Determined by an automated analyser.
Measured: Baseline and week 36
Changes from week 16 in triglycerides at week 36
Determined by an automated analyser.
Measured: Week 16 and week 36
Between group differences in fasting glucose at week 16
Determined by an automated analyser.
Measured: Week 16
Between group differences in fasting glucose at week 36
Determined by an automated analyser.
Measured: Week 36
Changes from baseline in fasting glucose at week 16
Determined by an automated analyser.
Measured: Baseline and week 16
Changes from baseline in fasting glucose at week 36
Determined by an automated analyser.
Measured: Baseline and week 36
Changes from week 16 in fasting glucose at week 36
Determined by an automated analyser.
Measured: Week 16 and week 36
Between group differences in fasting insulin at week 16
Determined by an automated analyser.
Measured: Week 16
Between group differences in fasting insulin at week 36
Determined by an automated analyser.
Measured: Week 36
Change from baseline in fasting insulin at week 16
Determined by an automated analyser.
Measured: Baseline and week 16
Change from baseline in fasting insulin at week 36
Determined by an automated analyser.
Measured: Baseline and week 36
Change from week 16 in fasting insulin at week 36
Determined by an automated analyser.
Measured: Week 16 and week 36
Between group differences in glucose tolerance at week 16
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
Measured: Week 16
Between group differences in glucose tolerance at week 36
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
Measured: Week 36
Changes from baseline in glucose tolerance at week 16
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
Measured: Baseline and week 16
Changes from baseline in glucose tolerance at week 36
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
Measured: Baseline and week 36
Changes from week 16 in glucose tolerance at week 36
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
Measured: Week 16 and week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start2 Jan 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Institute of Maia
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development, Universidade do Porto, University of Southern Denmark, Porto Sports Medicine Center (IPDJ, IP), Gaia City Hall, Portuguese Handball Federation, European Handball Federation, São João University Hospital Centre
- Responsible party
- Principal investigator, Susana Cristina Araújo Póvoas, University Institute of Maia
- Investigators
- Susana Póvoas, Principal investigator, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292261
- Sponsor's protocol ID
- CEFADE202019
- Acronym
- H4HW
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05292261
- Acronym / sponsor ID
- H4HW / CEFADE202019
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Institute of MaiaUniversity, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development, Universidade do Porto, University of Southern Denmark, Porto Sports Medicine Center (IPDJ, IP), Gaia City Hall, Portuguese Handball Federation, European Handball Federation, São João University Hospital Centre
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 23 Mar 2022 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Team handball group | Experimental | Other: Recreational team handballThe 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. |
| Control group | No intervention | –The control group participants were instructed to keep their regular daily physical activity for 36 weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years
Key exclusion criteria (1 listed)
- Any medical contraindications to perform moderate-to-vigorous physical activity
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 team handballTwo 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. | Other | Team handball group |
Primary outcome
Between group differences in peak oxygen uptake at week 16
Time frame: Week 16
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Between group differences in peak oxygen uptake at week 36
Time frame: Week 36
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Changes from baseline in peak oxygen uptake at week 16
Time frame: Baseline and week 16
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Changes from baseline in peak oxygen uptake at week 36
Time frame: Baseline and week 36
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Changes from week 16 in peak oxygen uptake at week 36
Time frame: Week 16 and week 36
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
130 secondary outcomes
Between group differences in resting heart rate at week 16
Time frame: Week 16
Between group differences in resting heart rate at week 36
Time frame: Week 36
Changes from baseline in resting heart rate at week 16
Time frame: Baseline and week 16
Changes from baseline in resting heart rate at week 36
Time frame: Baseline and week 36
Changes from week 16 in resting heart rate at week 36
Time frame: Week 16 and week 36
Between group differences in body mass at week 16
Time frame: Week 16
Between group differences in body mass at week 36
Time frame: Week 36
Changes from baseline in body mass at week 16
Time frame: Baseline and week 16
Changes from baseline in body mass at week 36
Time frame: Baseline and week 36
Changes from week 16 in body mass at week 36
Time frame: Week 16 and week 36
Between group differences in fat mass at week 16
Time frame: Week 16
Between group differences in fat mass at week 36
Time frame: Week 36
Changes from baseline in fat mass at week 16
Time frame: Baseline and week 16
Changes from baseline in fat mass at week 36
Time frame: Baseline and week 36
Changes from week 16 in fat mass at week 36
Time frame: Week 16 and week 36
Between group differences in lean mass at week 16
Time frame: Week 16
Between group differences in lean mass at week 36
Time frame: Week 36
Changes from baseline in lean mass at week 16
Time frame: Baseline and week 16
Changes from baseline in lean mass at week 36
Time frame: Baseline and week 36
Changes from week 16 in lean mass at week 36
Time frame: Week 16 and week 36
Between group differences in lumbar spine bone mineral density at week 16
Time frame: Week 16
Between group differences in lumbar spine bone mineral density at week 36
Time frame: Week 36
Changes from baseline in lumbar spine bone mineral density at week 16
Time frame: Baseline and week 16
Changes from baseline in lumbar spine bone mineral density at week 36
Time frame: Baseline and week 36
Changes from week 16 in lumbar spine bone mineral density at week 36
Time frame: Week 16 and week 36
Between group differences in dominant femur bone mineral density at week 16
Time frame: Week 16
Between group differences in dominant femur bone mineral density at week 36
Time frame: Week 36
Changes from baseline in dominant femur bone mineral density at week 16
Time frame: Baseline and week 16
Changes from baseline in dominant femur bone mineral density at week 36
Time frame: Baseline and week 36
Changes from week 16 in dominant femur bone mineral density at week 36
Time frame: Week 16 and week 36
Between group differences in dominant femoral neck bone mineral density at week 16
Time frame: Week 16
Between group differences in dominant femoral neck bone mineral density at week 36
Time frame: Week 36
Changes from baseline in dominant femoral neck bone mineral density at week 16
Time frame: Baseline and week 16
Changes from baseline in dominant femoral neck bone mineral density at week 36
Time frame: Baseline and week 36
Changes from week 16 in dominant femoral neck bone mineral density at week 36
Time frame: Week 16 and week 36
Between group differences in lumbar spine bone mineral content at week 16
Time frame: Week 16
Between group differences in lumbar spine bone mineral content at week 36
Time frame: Week 36
Changes from baseline in lumbar spine bone mineral content at week 16
Time frame: Baseline and week 16
Changes from baseline in lumbar spine bone mineral content at week 36
Time frame: Baseline and week 36
Changes from week 16 in lumbar spine bone mineral content at week 36
Time frame: Week 16 and week 36
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 6 Apr 2022.
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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.
Susana Póvoas principal investigator
University of Maia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recreational team handball in people with Menopause, run by University Institute of Maia at 1 site in Portugal.
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 1 inclusion and 1 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Between group differences in peak oxygen uptake at week 16 (time frame: Week 16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.