Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Middle-aged and Older Men ((H4HM))

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging
• Intervention / Treatment: Other: Recreational Team Handball programme

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto
    • Maia, Porto, Portugal, 4475-690
      • Univerisity of Maia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Team Handball 1; Team handball group participants were instructed to perform one weekly 60-min recreational team handball training sessions for 16 weeks.	Other: Recreational Team Handball programme; 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).
EXPERIMENTAL: Team Handball 2; Team handball group participants were instructed to perform two weekly 60-min recreational team handball training sessions for 16 weeks.	Other: Recreational Team Handball programme; 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).
EXPERIMENTAL: Team Handball 3; Team handball group participants were instructed to perform three weekly 60-min recreational team handball training sessions for 16 weeks.	Other: Recreational Team Handball programme; 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).
NO_INTERVENTION: Control Group; The control group participants were instructed to keep their regular daily physical activity for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): July 12, 2019
• Study Completion (ACTUAL): July 12, 2019

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (ACTUAL): March 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CEFADE 19 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No