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临床试验/NCT05292261
NCT05292261已完成不适用

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

University Institute of Maia2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Between group differences in peak oxygen uptake at week 16

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Between group differences in peak oxygen uptake at week 16

时间窗: Week 16

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

Changes from baseline in peak oxygen uptake at week 36

时间窗: Baseline and week 36

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

Between group differences in peak oxygen uptake at week 36

时间窗: Week 36

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

Changes from week 16 in peak oxygen uptake at week 36

时间窗: Week 16 and week 36

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

Changes from baseline in peak oxygen uptake at week 16

时间窗: Baseline and week 16

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

次要结局

  • Changes from baseline in fat mass at week 36(Baseline and week 36)
  • Changes from week 16 in resting heart rate at week 36(Week 16 and week 36)
  • Changes from baseline in body mass at week 16(Baseline and week 16)
  • Changes from week 16 in body mass at week 36(Week 16 and week 36)
  • Between group differences in fat mass at week 16(Week 16)
  • Between group differences in lumbar spine bone mineral density at week 36(Week 36)
  • Changes from week 16 in lumbar spine bone mineral density at week 36(Week 16 and week 36)
  • Between group differences in dominant femur bone mineral density at week 36(Week 36)
  • Between group differences in dominant femoral neck bone mineral density at week 36(Week 36)
  • Between group differences in resting heart rate at week 36(Week 36)
  • Between group differences in fat mass at week 36(Week 36)
  • Between group differences in lean mass at week 16(Week 16)
  • Between group differences in resting heart rate at week 16(Week 16)
  • Between group differences in body mass at week 16(Week 16)
  • Between group differences in body mass at week 36(Week 36)
  • Changes from week 16 in fat mass at week 36(Week 16 and week 36)
  • Between group differences in lean mass at week 36(Week 36)
  • Changes from baseline in osteocalcin at week 36(Baseline and week 36)
  • Changes from week 16 in osteocalcin at week 36(Week 16 and week 36)
  • Changes from baseline in resting heart rate at week 16(Baseline and week 16)
  • Changes from baseline in resting heart rate at week 36(Baseline and week 36)
  • Changes from baseline in body mass at week 36(Baseline and week 36)
  • Changes from baseline in fat mass at week 16(Baseline and week 16)
  • Changes from week 16 in lean mass at week 36(Week 16 and week 36)
  • Changes from baseline in high-density lipoprotein cholesterol at week 16(Baseline and week 16)
  • Changes from baseline in lean mass at week 16(Baseline and week 16)
  • Changes from baseline in lumbar spine bone mineral density at week 16(Baseline and week 16)
  • Changes from week 16 in dominant femur bone mineral density at week 36(Week 16 and week 36)
  • Changes from week 16 in dominant femoral neck bone mineral density at week 36(Week 16 and week 36)
  • Changes from baseline in dominant femur bone mineral content at week 16(Baseline and week 16)
  • Between group differences in osteocalcin at week 36(Week 36)
  • Changes from baseline in dominant femoral neck bone mineral density at week 16(Baseline and week 16)
  • Between group differences in dominant femur bone mineral content at week 16(Week 16)
  • Changes from baseline in dominant femoral neck bone mineral content at week 36(Baseline and week 36)
  • Changes from week 16 in dominant femoral neck bone mineral content at week 36(Week 16 and week 36)
  • Between group differences in osteocalcin at week 16(Week 16)
  • Between group differences in procollagen type-1 amino-terminal propeptide at week 36(Week 36)
  • Changes from baseline in lean mass at week 36(Baseline and week 36)
  • Changes from baseline in lumbar spine bone mineral density at week 36(Baseline and week 36)
  • Changes from baseline in dominant femur bone mineral density at week 16(Baseline and week 16)
  • Changes from baseline in dominant femur bone mineral density at week 36(Baseline and week 36)
  • Changes from baseline in dominant femoral neck bone mineral density at week 36(Baseline and week 36)
  • Between group differences in lumbar spine bone mineral content at week 16(Week 16)
  • Between group differences in dominant femur bone mineral content at week 36(Week 36)
  • Changes from baseline in dominant femur bone mineral content at week 36(Baseline and week 36)
  • Changes from baseline in dominant femoral neck bone mineral content at week 16(Baseline and week 16)
  • Between group differences in procollagen type-1 amino-terminal propeptide at week 16(Week 16)
  • Changes from baseline in procollagen type-1 amino-terminal propeptide at week 16(Baseline and week 16)
  • Changes from baseline in sclerostin at week 36(Baseline and week 36)
  • Changes from week 16 in sclerostin at week 36(Week 16 and week 36)
  • Between group differences in lumbar spine bone mineral density at week 16(Week 16)
  • Between group differences in dominant femur bone mineral density at week 16(Week 16)
  • Between group differences in dominant femoral neck bone mineral density at week 16(Week 16)
  • Between group differences in lumbar spine bone mineral content at week 36(Week 36)
  • Changes from baseline in lumbar spine bone mineral content at week 16(Baseline and week 16)
  • Changes from baseline in lumbar spine bone mineral content at week 36(Baseline and week 36)
  • Changes from week 16 in lumbar spine bone mineral content at week 36(Week 16 and week 36)
  • Changes from week 16 in dominant femur bone mineral content at week 36(Week 16 and week 36)
  • Between group differences in dominant femoral neck bone mineral content at week 36(Week 36)
  • Changes from baseline in osteocalcin at week 16(Baseline and week 16)
  • Changes from baseline in triglycerides at week 16(Baseline and week 16)
  • Between group differences in dominant femoral neck bone mineral content at week 16(Week 16)
  • Between group differences in sclerostin at week 16(Week 16)
  • Between group differences in isometric knee extension peak torque at week 16(Week 16)
  • Changes from week 16 in isometric knee extension peak torque at week 36(Week 16 and week 36)
  • Changes from week 16 in aerobic performance at week 36(Week 16 and week 36)
  • Between group differences in high-density lipoprotein cholesterol at week 36(Week 36)
  • Changes from week 16 in high-density lipoprotein cholesterol at week 36(Week 16 and week 36)
  • Between group differences in fasting glucose at week 36(Week 36)
  • Changes from baseline in triglycerides at week 36(Baseline and week 36)
  • Changes from week 16 in fasting glucose at week 36(Week 16 and week 36)
  • Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36(Week 16 and week 36)
  • Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16(Week 16)
  • Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16(Baseline and week 16)
  • Changes from baseline in isometric knee extension peak torque at week 16(Baseline and week 16)
  • Between group differences in isometric knee extension rate of force development at week 16(Week 16)
  • Between group differences in isometric knee extension rate of force development at week 36(Week 36)
  • Changes from baseline in isometric knee extension rate of force development at week 16(Baseline and week 16)
  • Between group differences in upper body strength at week 36(Week 36)
  • Between group differences in high-density lipoprotein cholesterol at week 16(Week 16)
  • Between group differences in fasting insulin at week 36(Week 36)
  • Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36(Baseline and week 36)
  • Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36(Week 36)
  • Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36(Week 16 and week 36)
  • Between group differences in sclerostin at week 36(Week 36)
  • Changes from baseline in sclerostin at week 16(Baseline and week 16)
  • Changes from baseline in isometric knee extension peak torque at week 36(Baseline and week 36)
  • Changes from baseline in isometric knee extension rate of force development at week 36(Baseline and week 36)
  • Changes from week 16 in isometric knee extension rate of force development at week 36(Week 16 and week 36)
  • Changes from baseline in upper body strength at week 36(Baseline and week 36)
  • Changes from baseline in aerobic performance at week 16(Baseline and week 16)
  • Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36(Baseline and week 36)
  • Between group differences in isometric knee extension peak torque at week 36(Week 36)
  • Changes from baseline in upper body strength at week 16(Baseline and week 16)
  • Changes from week 16 in upper body strength at week 36(Week 16 and week 36)
  • Between group differences in postural balance at week 36(Week 36)
  • Changes from week 16 in postural balance at week 36(Week 16 and week 36)
  • Between group differences in total cholesterol at week 16(Week 16)
  • Between group differences in total cholesterol at week 36(Week 36)
  • Changes from baseline in total cholesterol at week 36(Baseline and week 36)
  • Changes from week 16 in total cholesterol at week 36(Week 16 and week 36)
  • Changes from baseline in low-density lipoprotein cholesterol at week 36(Baseline and week 36)
  • Between group differences in triglycerides at week 16(Week 16)
  • Between group differences in triglycerides at week 36(Week 36)
  • Changes from week 16 in glucose tolerance at week 36(Week 16 and week 36)
  • Between group differences in upper body strength at week 16(Week 16)
  • Between group differences in postural balance at week 16(Week 16)
  • Changes from baseline in postural balance at week 16(Baseline and week 16)
  • Changes from baseline in postural balance at week 36(Baseline and week 36)
  • Between group differences in aerobic performance at week 16(Week 16)
  • Between group differences in aerobic performance at week 36(Week 36)
  • Changes from baseline in aerobic performance at week 36(Baseline and week 36)
  • Changes from baseline in total cholesterol at week 16(Baseline and week 16)
  • Changes from baseline in high-density lipoprotein cholesterol at week 36(Baseline and week 36)
  • Between group differences in low-density lipoprotein cholesterol at week 36(Week 36)
  • Changes from baseline in fasting glucose at week 16(Baseline and week 16)
  • Changes from baseline in fasting glucose at week 36(Baseline and week 36)
  • Between group differences in fasting insulin at week 16(Week 16)
  • Between group differences in low-density lipoprotein cholesterol at week 16(Week 16)
  • Changes from baseline in low-density lipoprotein cholesterol at week 16(Baseline and week 16)
  • Changes from week 16 in low-density lipoprotein cholesterol at week 36(Week 16 and week 36)
  • Changes from week 16 in triglycerides at week 36(Week 16 and week 36)
  • Between group differences in fasting glucose at week 16(Week 16)
  • Change from baseline in fasting insulin at week 16(Baseline and week 16)
  • Change from week 16 in fasting insulin at week 36(Week 16 and week 36)
  • Between group differences in glucose tolerance at week 36(Week 36)
  • Changes from baseline in glucose tolerance at week 16(Baseline and week 16)
  • Change from baseline in fasting insulin at week 36(Baseline and week 36)
  • Between group differences in glucose tolerance at week 16(Week 16)
  • Changes from baseline in glucose tolerance at week 36(Baseline and week 36)

研究者

发起方
University Institute of Maia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Susana Cristina Araújo Póvoas

Associate Professor

University Institute of Maia

研究点 (2)

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