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Completed

NCT Number: NCT05295511

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

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.

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Key information

Conditions

Healthy Aging

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Univerisity of Maia

Maia, Porto District, 4475-690, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recreational team handball programme

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    Whole-body mass was measured by a whole-body dual- energy X-ray absorptiometry following standard procedures

  5. 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

    Left arm total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  6. 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

    Right arm total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  7. 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

    Left leg total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  8. 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

    Right leg total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  9. 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

    Gynoid total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  10. 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

    Android total mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  11. 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

    Whole-body fat mass was measured by a whole-body dual- energy X-ray absorptiometry following standard procedures

  12. 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

    Left arm fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  13. 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

    Right arm fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  14. 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

    Left leg fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  15. 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

    Right leg fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  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

    Gynoid fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  17. 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

    Android fat mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  18. 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

    Whole-body lean mass was measured by a whole-body dual- energy X-ray absorptiometry following standard procedures

  19. 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

    Left arm lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  20. 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

    Right arm lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  21. 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

    Left leg lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  22. 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

    Right leg lean mass was measured by a regional-body dual- energy X-ray absorptiometry following standard procedures

  23. 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

    Whole-body bone mineral density dual- energy X-ray absorptiometry scans following standard procedures.

  24. 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

    Whole-body bone mineral content dual- energy X-ray absorptiometry scans following standard procedures.

  25. 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

    Lumbar spine bone mineral density dual- energy X-ray absorptiometry regional scans following standard procedures.

  26. 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

    Lumbar spine bone mineral content dual- energy X-ray absorptiometry regional scans following standard procedures.

  27. 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

    Femur bone mineral density dual- energy X-ray absorptiometry regional scans following standard procedures.

  28. 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

    Femur bone mineral content dual- energy X-ray absorptiometry regional scans following standard procedures.

  29. 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

    Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.

  30. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in osteocalcin

    Time frame: Baseline and week 16

    Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.

  31. 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

    Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.

  32. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in sclerostin

    Time frame: Baseline and week 16

    Plasma concentrations of biochemical bone turnover markers were analyzed by chemiluminescence method using a fully automated immunoassay system.

  33. 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

    Isometric upper body strength was measured by a handgrip dynamometer (kg).

  34. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in postural balance

    Time frame: Baseline and week 16

    Postural balance was evaluated by the number of falls in a single-legged flamingo balance test.

  35. 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

    Upper and lower body strength (N), and coordination (s) tests were measured according to Rikili and Jones ( 2013) standardized protocols.

  36. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in aerobic performance

    Time frame: Baseline and week 16

    Aerobic performance (Yo-Yo intermittent endurance level 1 test; YYIE1) (m) was evaluated on an indoor team handball court, acording to a standardized protocol.

  37. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in total cholesterol

    Time frame: Baseline and week 16

    Total cholesterol (mg/dl) was determined by an automated analyzer.

  38. 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

    High-density lipoprotein cholesterol (mg/dl) was determined by an automated analyzer.

  39. 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

    Low-density lipoprotein cholesterol (mg/dl) was determined by an automated analyzer.

  40. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in triglycerides

    Time frame: Baseline and week 16

    Triglycerides (mg/dl) was determined by an automated analyzer.

  41. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glycosylated haemoglobin

    Time frame: Baseline and week 16

    Glycosylated haemoglobin (%) was determined by an automated analyzer.

  42. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glucose

    Time frame: Baseline and week 16

    Glucose (mg/dl) was determined by an automated analyzer.

  43. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in insulin

    Time frame: Baseline and week 16

    Fasting blood insulin (µmol/L) was determined was determined by an automated analyzer.

  44. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in total antioxidant status

    Time frame: Baseline and week 16

    Total antioxidant status (TAS) (mmol/L) was measured in plasma samples using AU5800 (Beckman-Coulter®, USA)

  45. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glutathione reductase

    Time frame: Baseline and week 16

    Glutathione reductase (GR) (U/L) was measured in plasma samples using AU5800 (Beckman-Coulter®, USA)

  46. Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glutathione peroxidase

    Time frame: Baseline and week 16

    Glutathione peroxidase (GPx) (U/L) was measured in plasma samples using AU5800 (Beckman-Coulter®, USA)

Sponsors and collaborators

Lead sponsor

University Institute of Maia

Other

Collaborators

  • Gaia City Hall
  • Porto Sports Medicine Center (IPDJ, IP)
  • Portuguese Handball Federation
  • Research Center in Sports Sciences, Health Sciences and Human Development
  • São João University Hospital Centre
  • Universidade do Porto
  • University of Southern Denmark

Registry information

Official study 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

Acronym: (H4HM)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2022
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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