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Completed

NCT Number: NCT05292261

Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women

This study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport.

The investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. Moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).

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Key information

Conditions

Menopause

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Maia

Maia, Porto District, 4476-690, Portugal

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years

Exclusion criteria

  • Any medical contraindications to perform moderate-to-vigorous physical activity

Treatment and study plan

Recreational team handball

Other

Two to three weekly sessions of recreational team handball training for 36 weeks. Each 60-min session started with a standardised warm-up (including running, coordination, strength, flexibility, and balance exercises) followed by three 15-min periods of recreational team handball matches, interspersed by 2-min breaks, played as small-sided games (4v4, 5v5 or 6v6). The training sessions were performed on an indoor team handball court (40x20 m) adjusted to result in 34-36 m2 per player. During the matches, the participants rotated positions every 3 min in a random order, including the goalkeeper and no exclusions or substitutions were applied.

Primary outcomes

  1. Between group differences in peak oxygen uptake at week 16

    Time frame: Week 16

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

  2. Between group differences in peak oxygen uptake at week 36

    Time frame: Week 36

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

  3. Changes from baseline in peak oxygen uptake at week 16

    Time frame: Baseline and week 16

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

  4. Changes from baseline in peak oxygen uptake at week 36

    Time frame: Baseline and week 36

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

  5. Changes from week 16 in peak oxygen uptake at week 36

    Time frame: Week 16 and week 36

    Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.

Secondary outcomes

  1. Between group differences in resting heart rate at week 16

    Time frame: Week 16

    Determined by an automatic upper arm blood pressure monitor according to standardized procedures.

  2. Between group differences in resting heart rate at week 36

    Time frame: Week 36

    Determined by an automatic upper arm blood pressure monitor according to standardized procedures.

  3. Changes from baseline in resting heart rate at week 16

    Time frame: Baseline and week 16

    Determined by an automatic upper arm blood pressure monitor according to standardized procedures.

  4. Changes from baseline in resting heart rate at week 36

    Time frame: Baseline and week 36

    Determined by an automatic upper arm blood pressure monitor according to standardized procedures.

  5. Changes from week 16 in resting heart rate at week 36

    Time frame: Week 16 and week 36

    Determined by an automatic upper arm blood pressure monitor according to standardized procedures.

  6. Between group differences in body mass at week 16

    Time frame: Week 16

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  7. Between group differences in body mass at week 36

    Time frame: Week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  8. Changes from baseline in body mass at week 16

    Time frame: Baseline and week 16

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  9. Changes from baseline in body mass at week 36

    Time frame: Baseline and week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  10. Changes from week 16 in body mass at week 36

    Time frame: Week 16 and week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  11. Between group differences in fat mass at week 16

    Time frame: Week 16

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  12. Between group differences in fat mass at week 36

    Time frame: Week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  13. Changes from baseline in fat mass at week 16

    Time frame: Baseline and week 16

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  14. Changes from baseline in fat mass at week 36

    Time frame: Baseline and week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  15. Changes from week 16 in fat mass at week 36

    Time frame: Week 16 and week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  16. Between group differences in lean mass at week 16

    Time frame: Week 16

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  17. Between group differences in lean mass at week 36

    Time frame: Week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  18. Changes from baseline in lean mass at week 16

    Time frame: Baseline and week 16

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  19. Changes from baseline in lean mass at week 36

    Time frame: Baseline and week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  20. Changes from week 16 in lean mass at week 36

    Time frame: Week 16 and week 36

    Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.

  21. Between group differences in lumbar spine bone mineral density at week 16

    Time frame: Week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  22. Between group differences in lumbar spine bone mineral density at week 36

    Time frame: Week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  23. Changes from baseline in lumbar spine bone mineral density at week 16

    Time frame: Baseline and week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  24. Changes from baseline in lumbar spine bone mineral density at week 36

    Time frame: Baseline and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  25. Changes from week 16 in lumbar spine bone mineral density at week 36

    Time frame: Week 16 and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  26. Between group differences in dominant femur bone mineral density at week 16

    Time frame: Week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  27. Between group differences in dominant femur bone mineral density at week 36

    Time frame: Week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  28. Changes from baseline in dominant femur bone mineral density at week 16

    Time frame: Baseline and week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  29. Changes from baseline in dominant femur bone mineral density at week 36

    Time frame: Baseline and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  30. Changes from week 16 in dominant femur bone mineral density at week 36

    Time frame: Week 16 and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  31. Between group differences in dominant femoral neck bone mineral density at week 16

    Time frame: Week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  32. Between group differences in dominant femoral neck bone mineral density at week 36

    Time frame: Week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  33. Changes from baseline in dominant femoral neck bone mineral density at week 16

    Time frame: Baseline and week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  34. Changes from baseline in dominant femoral neck bone mineral density at week 36

    Time frame: Baseline and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  35. Changes from week 16 in dominant femoral neck bone mineral density at week 36

    Time frame: Week 16 and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  36. Between group differences in lumbar spine bone mineral content at week 16

    Time frame: Week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  37. Between group differences in lumbar spine bone mineral content at week 36

    Time frame: Week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  38. Changes from baseline in lumbar spine bone mineral content at week 16

    Time frame: Baseline and week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  39. Changes from baseline in lumbar spine bone mineral content at week 36

    Time frame: Baseline and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  40. Changes from week 16 in lumbar spine bone mineral content at week 36

    Time frame: Week 16 and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  41. Between group differences in dominant femur bone mineral content at week 16

    Time frame: Week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  42. Between group differences in dominant femur bone mineral content at week 36

    Time frame: Week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  43. Changes from baseline in dominant femur bone mineral content at week 16

    Time frame: Baseline and week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  44. Changes from baseline in dominant femur bone mineral content at week 36

    Time frame: Baseline and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  45. Changes from week 16 in dominant femur bone mineral content at week 36

    Time frame: Week 16 and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  46. Between group differences in dominant femoral neck bone mineral content at week 16

    Time frame: Week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  47. Between group differences in dominant femoral neck bone mineral content at week 36

    Time frame: Week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  48. Changes from baseline in dominant femoral neck bone mineral content at week 16

    Time frame: Baseline and week 16

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  49. Changes from baseline in dominant femoral neck bone mineral content at week 36

    Time frame: Baseline and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  50. Changes from week 16 in dominant femoral neck bone mineral content at week 36

    Time frame: Week 16 and week 36

    Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.

  51. Between group differences in osteocalcin at week 16

    Time frame: Week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  52. Between group differences in osteocalcin at week 36

    Time frame: Week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  53. Changes from baseline in osteocalcin at week 16

    Time frame: Baseline and week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  54. Changes from baseline in osteocalcin at week 36

    Time frame: Baseline and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  55. Changes from week 16 in osteocalcin at week 36

    Time frame: Week 16 and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  56. Between group differences in procollagen type-1 amino-terminal propeptide at week 16

    Time frame: Week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  57. Between group differences in procollagen type-1 amino-terminal propeptide at week 36

    Time frame: Week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  58. Changes from baseline in procollagen type-1 amino-terminal propeptide at week 16

    Time frame: Baseline and week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  59. Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36

    Time frame: Baseline and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  60. Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36

    Time frame: Week 16 and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  61. Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16

    Time frame: Week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  62. Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36

    Time frame: Week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  63. Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16

    Time frame: Baseline and week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  64. Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36

    Time frame: Baseline and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  65. Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36

    Time frame: Week 16 and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  66. Between group differences in sclerostin at week 16

    Time frame: Week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  67. Between group differences in sclerostin at week 36

    Time frame: Week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  68. Changes from baseline in sclerostin at week 16

    Time frame: Baseline and week 16

    Determined by chemiluminescence method using a fully automated immunoassay system.

  69. Changes from baseline in sclerostin at week 36

    Time frame: Baseline and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  70. Changes from week 16 in sclerostin at week 36

    Time frame: Week 16 and week 36

    Determined by chemiluminescence method using a fully automated immunoassay system.

  71. Between group differences in isometric knee extension peak torque at week 16

    Time frame: Week 16

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  72. Between group differences in isometric knee extension peak torque at week 36

    Time frame: Week 36

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  73. Changes from baseline in isometric knee extension peak torque at week 16

    Time frame: Baseline and week 16

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  74. Changes from baseline in isometric knee extension peak torque at week 36

    Time frame: Baseline and week 36

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  75. Changes from week 16 in isometric knee extension peak torque at week 36

    Time frame: Week 16 and week 36

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  76. Between group differences in isometric knee extension rate of force development at week 16

    Time frame: Week 16

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  77. Between group differences in isometric knee extension rate of force development at week 36

    Time frame: Week 36

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  78. Changes from baseline in isometric knee extension rate of force development at week 16

    Time frame: Baseline and week 16

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  79. Changes from baseline in isometric knee extension rate of force development at week 36

    Time frame: Baseline and week 36

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  80. Changes from week 16 in isometric knee extension rate of force development at week 36

    Time frame: Week 16 and week 36

    Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction

  81. Between group differences in upper body strength at week 16

    Time frame: Week 16

    Determined by a handgrip dynamometer.

  82. Between group differences in upper body strength at week 36

    Time frame: Week 36

    Determined by a handgrip dynamometer.

  83. Changes from baseline in upper body strength at week 16

    Time frame: Baseline and week 16

    Determined by a handgrip dynamometer.

  84. Changes from baseline in upper body strength at week 36

    Time frame: Baseline and week 36

    Determined by a handgrip dynamometer.

  85. Changes from week 16 in upper body strength at week 36

    Time frame: Week 16 and week 36

    Determined by a handgrip dynamometer.

  86. Between group differences in postural balance at week 16

    Time frame: Week 16

    Determined by the number of falls in a single-legged flamingo balance test.

  87. Between group differences in postural balance at week 36

    Time frame: Week 36

    Determined by the number of falls in a single-legged flamingo balance test.

  88. Changes from baseline in postural balance at week 16

    Time frame: Baseline and week 16

    Determined by the number of falls in a single-legged flamingo balance test.

  89. Changes from baseline in postural balance at week 36

    Time frame: Baseline and week 36

    Determined by the number of falls in a single-legged flamingo balance test.

  90. Changes from week 16 in postural balance at week 36

    Time frame: Week 16 and week 36

    Determined by the number of falls in a single-legged flamingo balance test.

  91. Between group differences in aerobic performance at week 16

    Time frame: Week 16

    Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.

  92. Between group differences in aerobic performance at week 36

    Time frame: Week 36

    Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.

  93. Changes from baseline in aerobic performance at week 16

    Time frame: Baseline and week 16

    Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.

  94. Changes from baseline in aerobic performance at week 36

    Time frame: Baseline and week 36

    Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.

  95. Changes from week 16 in aerobic performance at week 36

    Time frame: Week 16 and week 36

    Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.

  96. Between group differences in total cholesterol at week 16

    Time frame: Week 16

    Determined by an automated analyser.

  97. Between group differences in total cholesterol at week 36

    Time frame: Week 36

    Determined by an automated analyser.

  98. Changes from baseline in total cholesterol at week 16

    Time frame: Baseline and week 16

    Determined by an automated analyser.

  99. Changes from baseline in total cholesterol at week 36

    Time frame: Baseline and week 36

    Determined by an automated analyser.

  100. Changes from week 16 in total cholesterol at week 36

    Time frame: Week 16 and week 36

    Determined by an automated analyser.

  101. Between group differences in high-density lipoprotein cholesterol at week 16

    Time frame: Week 16

    Determined by an automated analyser.

  102. Between group differences in high-density lipoprotein cholesterol at week 36

    Time frame: Week 36

    Determined by an automated analyser.

  103. Changes from baseline in high-density lipoprotein cholesterol at week 16

    Time frame: Baseline and week 16

    Determined by an automated analyser.

  104. Changes from baseline in high-density lipoprotein cholesterol at week 36

    Time frame: Baseline and week 36

    Determined by an automated analyser.

  105. Changes from week 16 in high-density lipoprotein cholesterol at week 36

    Time frame: Week 16 and week 36

    Determined by an automated analyser.

  106. Between group differences in low-density lipoprotein cholesterol at week 16

    Time frame: Week 16

    Determined by an automated analyser.

  107. Between group differences in low-density lipoprotein cholesterol at week 36

    Time frame: Week 36

    Determined by an automated analyser.

  108. Changes from baseline in low-density lipoprotein cholesterol at week 16

    Time frame: Baseline and week 16

    Determined by an automated analyser.

  109. Changes from baseline in low-density lipoprotein cholesterol at week 36

    Time frame: Baseline and week 36

    Determined by an automated analyser.

  110. Changes from week 16 in low-density lipoprotein cholesterol at week 36

    Time frame: Week 16 and week 36

    Determined by an automated analyser.

  111. Between group differences in triglycerides at week 16

    Time frame: Week 16

    Determined by an automated analyser.

  112. Between group differences in triglycerides at week 36

    Time frame: Week 36

    Determined by an automated analyser.

  113. Changes from baseline in triglycerides at week 16

    Time frame: Baseline and week 16

    Determined by an automated analyser.

  114. Changes from baseline in triglycerides at week 36

    Time frame: Baseline and week 36

    Determined by an automated analyser.

  115. Changes from week 16 in triglycerides at week 36

    Time frame: Week 16 and week 36

    Determined by an automated analyser.

  116. Between group differences in fasting glucose at week 16

    Time frame: Week 16

    Determined by an automated analyser.

  117. Between group differences in fasting glucose at week 36

    Time frame: Week 36

    Determined by an automated analyser.

  118. Changes from baseline in fasting glucose at week 16

    Time frame: Baseline and week 16

    Determined by an automated analyser.

  119. Changes from baseline in fasting glucose at week 36

    Time frame: Baseline and week 36

    Determined by an automated analyser.

  120. Changes from week 16 in fasting glucose at week 36

    Time frame: Week 16 and week 36

    Determined by an automated analyser.

  121. Between group differences in fasting insulin at week 16

    Time frame: Week 16

    Determined by an automated analyser.

  122. Between group differences in fasting insulin at week 36

    Time frame: Week 36

    Determined by an automated analyser.

  123. Change from baseline in fasting insulin at week 16

    Time frame: Baseline and week 16

    Determined by an automated analyser.

  124. Change from baseline in fasting insulin at week 36

    Time frame: Baseline and week 36

    Determined by an automated analyser.

  125. Change from week 16 in fasting insulin at week 36

    Time frame: Week 16 and week 36

    Determined by an automated analyser.

  126. Between group differences in glucose tolerance at week 16

    Time frame: Week 16

    Determined by an oral glucose tolerance teste, analysed by an automated analyser.

  127. Between group differences in glucose tolerance at week 36

    Time frame: Week 36

    Determined by an oral glucose tolerance teste, analysed by an automated analyser.

  128. Changes from baseline in glucose tolerance at week 16

    Time frame: Baseline and week 16

    Determined by an oral glucose tolerance teste, analysed by an automated analyser.

  129. Changes from baseline in glucose tolerance at week 36

    Time frame: Baseline and week 36

    Determined by an oral glucose tolerance teste, analysed by an automated analyser.

  130. Changes from week 16 in glucose tolerance at week 36

    Time frame: Week 16 and week 36

    Determined by an oral glucose tolerance teste, analysed by an automated analyser.

Sponsors and collaborators

Lead sponsor

University Institute of Maia

Other

Collaborators

  • European Handball Federation
  • 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

Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women

Acronym: H4HW

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 23, 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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