Healthy Aging(H4HM)NCT05295511
Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Middle-aged and Older Men
A study testing Recreational Team Handball programme in people with Healthy Aging, run by University Institute of Maia at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Recreational Team Handball programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2017to 12 Jul 2019
- 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 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants; inactive with 50 or more years of age (i.e., not complying with the physical activity guidelines for the last 6 months).
Who cannot join
- Any medical contraindication to perform moderate-to-vigorous physical activity; incapacity to run or grip a ball.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-response Effects of a Recreational Team Handball-based Exercise Programme on Cardiovascular, Metabolic, Musculoskeletal and Physical Fitness Markers in Inactive Middle-aged and Older Male
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.
- Conditions
- Healthy Aging
- Being tested
- Recreational Team Handball programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreational Team Handball programmeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Team Handball 1 | Experimental | Team handball group participants were instructed to perform one weekly 60-min recreational team handball training sessions for 16 weeks. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Systolic blood pressure (mmHg) was measured in a laboratory by an automatic upper arm blood pressure monitor (multiparameter patient monitor, Omron Z207, Kyoto, Japan) according to standardized procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in diastolic blood pressure
Diastolic blood pressure (mmHg) was measured in a laboratory by an automatic upper arm blood pressure monitor (multiparameter patient monitor, Omron Z207, Kyoto, Japan) according to standardized procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in resting heart rate
Resting heart rate (bpm) was measured in a laboratory by an automatic upper arm blood pressure monitor (multiparameter patient monitor, Omron Z207, Kyoto, Japan) according to standardized procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body mass
Whole-body mass was measured by a whole-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm total mass
Left arm total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm total mass
Right arm total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg total mass
Left leg total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg total mass
Right leg total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in gynoid total mass
Gynoid total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in android total mass
Android total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body fat mass
Whole-body fat mass was measured by a whole-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm fat mass
Left arm fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm fat mass
Right arm fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg fat mass
Left leg fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg fat mass
Right leg fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in gynoid fat mass
Gynoid fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in android fat mass
Android fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body lean mass
Whole-body lean mass was measured by a whole-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm lean mass
Left arm lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm lean mass
Right arm lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg lean mass
Left leg lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg lean mass
Right leg lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body bone mineral density
Whole-body bone mineral density dual- energy X-ray absorptiometry scans following standard procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body bone mineral content
Whole-body bone mineral content dual- energy X-ray absorptiometry scans following standard procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in lumbar spine bone mineral density
Lumbar spine bone mineral density dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in lumbar spine bone mineral content
Lumbar spine bone mineral content dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in femur bone mineral density
Femur bone mineral density dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in femur bone mineral content
Femur bone mineral content dual- energy X-ray absorptiometry regional scans following standard procedures.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in procollagen type-1 amino-terminal propeptide
Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in osteocalcin
Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in carboxy-terminal type-1 collagen crosslinks
Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in sclerostin
Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in isometric upper body strength
Isometric upper body strength was measured by a handgrip dynamometer (kg).
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in postural balance
Postural balance was evaluated by the number of falls in a single-legged flamingo balance test.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in upper and lower body strength, and coordination
Upper and lower body strength (N), and coordination (s) tests were measured according to Rikili and Jones ( 2013) standardized protocols.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in aerobic performance
Aerobic performance (Yo-Yo intermittent endurance level 1 test; YYIE1) (m) was evaluated on an indoor team handball court, acording to a standardized protocol.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in total cholesterol
Total cholesterol (mg/dl) was determined by an automated analyzer.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in high-density lipoprotein cholesterol
High-density lipoprotein cholesterol (mg/dl) was determined by an automated analyzer.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol (mg/dl) was determined by an automated analyzer.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in triglycerides
Triglycerides (mg/dl) was determined by an automated analyzer.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glycosylated haemoglobin
Glycosylated haemoglobin (%) was determined by an automated analyzer.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glucose
Glucose (mg/dl) was determined by an automated analyzer.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in insulin
Fasting blood insulin (µmol/L) was determined was determined by an automated analyzer.
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in total antioxidant status
Total antioxidant status (TAS) (mmol/L) was measured in plasma samples using AU5800 (Beckman-Coulter®, USA)
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glutathione reductase
Glutathione reductase (GR) (U/L) was measured in plasma samples using AU5800 (Beckman-Coulter®, USA)
Measured: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glutathione peroxidase
Glutathione peroxidase (GPx) (U/L) was measured in plasma samples using AU5800 (Beckman-Coulter®, USA)
Measured: Baseline and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Dec 2017
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies 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
- 68 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, 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
- NCT05295511
- Sponsor's protocol ID
- CEFADE 19 2019
- Acronym
- (H4HM)
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37376804Carneiro 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.
PubMed 37162301
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
- Dose-response Effects of a Recreational Team Handball-based Exercise Programme on Cardiovascular, Metabolic, Musculoskeletal and Physical Fitness Markers in Inactive Middle-aged and Older Male
- ClinicalTrials.gov ID
- NCT05295511
- Acronym / sponsor ID
- (H4HM) / CEFADE 19 2019
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 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, São João University Hospital Centre
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 25 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Team Handball 1 | Experimental | Other: Recreational Team Handball programmeTeam handball group participants were instructed to perform one weekly 60-min recreational team handball training sessions for 16 weeks. |
| Team Handball 2 | Experimental | Other: Recreational Team Handball programmeTeam handball group participants were instructed to perform two weekly 60-min recreational team handball training sessions for 16 weeks. |
| Team Handball 3 | Experimental | Other: Recreational Team Handball programmeTeam handball group participants were instructed to perform three weekly 60-min recreational team handball training sessions for 16 weeks. |
| Control Group | No intervention | –The control group participants were instructed to keep their regular daily physical activity for 16 weeks. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male participants; inactive with 50 or more years of age (i.e., not complying with the physical activity guidelines for the last 6 months).
Key exclusion criteria (1 listed)
- Any medical contraindication to perform moderate-to-vigorous physical activity; incapacity to run or grip a ball.
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 Handball programmeAll 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). | Other | Team Handball 1, Team Handball 2, Team Handball 3 |
Primary outcome
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in maximal oxygen uptake
Time frame: Baseline and week 16
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.
46 secondary outcomes
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in systolic blood pressure
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in diastolic blood pressure
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in resting heart rate
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm total mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm total mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg total mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg total mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in gynoid total mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in android total mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body fat mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm fat mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm fat mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg fat mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg fat mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in gynoid fat mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in android fat mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body lean mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm lean mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm lean mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg lean mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg lean mass
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body bone mineral density
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body bone mineral content
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in lumbar spine bone mineral density
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in lumbar spine bone mineral content
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in femur bone mineral density
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in femur bone mineral content
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in procollagen type-1 amino-terminal propeptide
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in osteocalcin
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in carboxy-terminal type-1 collagen crosslinks
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in sclerostin
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in isometric upper body strength
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in postural balance
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in upper and lower body strength, and coordination
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in aerobic performance
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in total cholesterol
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in high-density lipoprotein cholesterol
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in low-density lipoprotein cholesterol
Time frame: Baseline and week 16
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in triglycerides
Time frame: Baseline and week 16
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.
- Derived from this study: PubMed 37376804Carneiro 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.
- Derived from this study: PubMed 37162301Carneiro 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.
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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 programme in people with Healthy Aging, 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?
Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in maximal oxygen uptake (time frame: Baseline and week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05295511, which also lists 2 linked publications.
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.