Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male (ADAM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change From Baseline in Lean Mass
研究概览
简要总结
This study examines the effect of 12-week strength training program with and without testosterone replacement therapy (TRT) on body composition, physical function, selected biochemical markers of metabolic health, molecular parameters of training adaptation and the quality of life patients with ADAM. The investigators believe, that strength training program performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and gain lean mass), muscle strength, muscle power and general quality of life in all training groups. In addition, combination TRT and strength training could help decrease fat mass, improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for hypogonadal ageing males.
详细描述
The study is 3 groups controlled 12-week study to assess the effect of testosterone replacement therapy (TRT) with strength training (ST) and strength training (ST) for hypogonadal participants without testosterone replacement therapy (NON-TRT) with control healthy eugonadal group, that is also engaged in strength training.
Strength training protocol starts one week after all the pre-intervention testing. The intervention is performed at the Comenius University in Bratislava, Faculty of Physical Education and Sport (FSPORT CU) in Slovakia. The strength training protocol follows a modified resistance exercise program. The participants perform strength training sessions two times per week for 12 weeks. All training sessions are supervised and guided by professional coaches with university degree in sports training to ensure safety, technique and progression in training load, with a maximum of three participants per coach.
Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The participants are instructed to perform concentric action in 2 s and immediately after eccentric action in also 2 s. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press. Training equipment is provided by KOHI Leopoldov, Slovakia and Technogym, Italia.
Clinical and muscle cellular outcomes are collected before the intervention (pre-testing assessments) and after the intervention (post-testing assessments). Post intervention measurements start 7 days after intervention and go up to 3 weeks after intervention.
Clinical outcomes Body composition analysis is measured by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series. LBM(lean body mass) is measured in total body and separately for arms, legs and trunk. The changes in lower and upper body LBM are investigated separately because of differences in androgen sensitivity in leg muscles compared to neck, chest and shoulder muscles. Body weight is measured by bioimpedance scale, the height by stadiometer and waist circumference by tape. The body mass index is calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients of secondary hypogonadism on testosterone replacement therapy, newly diagnosed patients of secondary hypogonadism.
排除标准
- •Regular strength training, medical treating osteoporosis, abnormal digital rectal results, conditions which are medical contraindications (without adjusting state): diabetes mellitus, severe cardiac arrhythmia, uncontrolled hypertension, unstable angina pectoris, chronic obstructive pulmonary disease, epilepsy, unstable bone lesions with high risk of fracture, prostate cancer or abnormal serum PSA levels without adverse histological examination.
结局指标
主要结局
Change From Baseline in Lean Mass
时间窗: 7 days before intervention, 7 days after intervention
Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
次要结局
- Change From Baseline in Handgrip Strength(7 days before intervention, 7 days after intervention)
- Change From Baseline in Total Body Mass(7 days before intervention, 7 days after intervention)
- Change From Baseline in 10-m Usual Walk Test(7 days before intervention, 7 days after intervention)
- Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension(7 days before intervention, 7 days after intervention)
- Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion(7 days before intervention, 7 days after intervention)
- Change From Baseline in Aging Males' Symptom (AMS) Scale(7 days before intervention, 7 days after intervention)
- Change From Baseline in 10-m Fast Walk Test(7 days before intervention, 7 days after intervention)
- Change From Baseline in The Single Stage Treadmill Walking Test(7 days before intervention, 7 days after intervention)
- Change From Baseline in Maximal Voluntary Contraction in Benchpress(7 days before intervention, 7 days after intervention)
- Change From Baseline in Muscle Fiber Size(7 days before intervention, 14 days after intervention)
- Change From Baseline in Fat Mass(7 days before intervention, 7 days after intervention)
- Change From Baseline in Predicted One Repetition Maximum on Leg Press(7 days before intervention, 7 days after intervention)
- Change From Baseline in Hormonal Parameters(7 days before intervention, 14 days after intervention)
- Change From Baseline in The Short Form Health Survey (SF-36)(7 days before intervention, 7 days after intervention)
- Change From Baseline in Metabolic Parameters(7 days before intervention, 7 days after intervention)
- Change From Baseline in Liver Function Blood Parameters(7 days before intervention, 14 days after intervention)
- Change From Baseline in Regulators of Muscle Fiber Size(7 days before intervention, 14 days after intervention)
- Change From Baseline in Ions(7 days before intervention, 14 days after intervention)
- Change From Baseline in CRP(7 days before intervention, 14 days after intervention)
研究者
Milan Sedliak
Independent researcher, Vice-dean for science, research and international cooperation
Comenius University