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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Aging

Intervention / Treatment
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* Other: Recreational Team Handball programme


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team Handball 1<br>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<br>* 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).<br>|
| Experimental: Team Handball 2<br>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<br>* 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).<br>|
| Experimental: Team Handball 3<br>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<br>* 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).<br>|
| No Intervention: Control Group<br>The control group participants were instructed to keep their regular daily physical activity for 16 weeks. | |

What is the study measuring?
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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 |