Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Middle-aged and Older Men

Healthy Aging Clinical Trial

— (H4HM)  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295511
• Other study ID #: CEFADE 19 2019
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: March 2022
• Source: University Institute of Maia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The researchers hypothesized a positive weekly training frequency effect on health and physical fitness outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Other:
• Recreational Team Handball programme
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).

Locations

Country	Name	City	State
Portugal	Univerisity of Maia	Maia	Porto

Sponsors (11)

Lead Sponsor

Collaborator

University Institute of Maia

Centre of Research, Education, Innovation and Intervention in Sport, University of Porto, EPIUnit, Public Health Institute, University of Porto, Gaia City Hall, Porto Sports Medicine Center (IPDJ, IP), Portuguese Handball Federation, Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, São João University Hospital Centre, Universidade do Porto, University of Southern Denmark

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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).	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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)	Baseline and week 16
Secondary	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)	Baseline and week 16
Secondary	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)	Baseline and week 16