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临床试验/NCT05893641
NCT05893641招募中3 期

Investigate the Relationship Between Exercise Training and Recovery to Improve Physical Performance and Health Indices

Tel Aviv University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
200
试验地点
2
主要终点
Changes in endocrine measurements

研究概览

简要总结

This study aims to investigate the effectiveness of various recovery strategies (such as longer recovery periods or reduced exercise intensity) in optimizing both physical performance and overall health status. Furthermore, the study will explore the potential of using changes in blood and urinary markers as indicators for assessing recovery status.

This study will assess whether extending recovery periods between exercise sessions and reducing the volume of exercise training can enhance the recovery process and enhance performance and health-related markers, relative to a control group.

One hundred-fifth young males will be recruited to participate in a single-center, parallel-group, randomized, well-controlled, superiority trial for 8 weeks of high-volume exercise training.

A single-center, parallel-group, randomized, well-controlled, superiority trial will be conducted among 150 physically active young males. Participants will undergo an 8-week high-volume exercise during base training program, which they will be randomly assigned to one of three groups: (1) a control group, which will follow the standard exercise regimen of 35 hours/week (n = 50); (2) a less exercise volume group, which will reduce exercise volume by 15% to 30 hours/week (n = 50); and (3) an extended recovery group, which will perform the same volume of exercise as the control group (35 hours/week), but with longer recovery intervals between exercises (n = 50). The intervention will take place at the Ministry of Defense training platform.

All study measurements will be taken at baseline and throughout the study. Body composition will be assessed using multichannel bioelectrical impedance (Seca). Continuously monitor (Garmin) will be used to evaluate heart rate and heart rate variability. Fasting blood samples will be used to examine inflammatory, lipid, glycemic, and endocrine markers. Physical performance will be assessed by several validated assessments, including handgrip, maximal voluntary contraction, Wingate test, Isometric Mid-Thigh Pull (IMTP), counter movement jump (CMJ) and maximal oxygen consumption (VO2max).

详细描述

The primary aim will be to determine the effect of different recovery strategies during 8 weeks of well-controlled, high-volume, large-scale, exercise training on the immune system (a), cardio-metabolic markers (b), and endocrine response (c).

Secondary aims will include: (1) To determine the effect of different recovery strategies during 8 weeks of well-controlled, high-volume, large-scale, exercise training on body strength (a), aerobic capacity (b), and body composition (c).

After baseline measurements, participants will be randomized 1:1:1 into one of three groups for 8 weeks: (1) a control group, which will follow the standard exercise regimen of 35 hours/week (n = 50); (2) a less exercise volume group, which will reduce exercise volume by 15% to 30 hours/week (n = 50); and (3) an extended recovery group, which will perform the same volume of exercise as the control group (35 hours/week), but with longer recovery intervals between exercises (n = 50).

Changes in health indices will be assessed by cardiometabolic, endocrine, and immune blood markers and body composition assessment at baseline (T0) after, 4 (T4), and 8 (T8) weeks of the intervention. Aerobic capacity, anaerobic threshold, and strength measurements will be used to determine changes in performance at T0, T4, and T8.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Highly active participants
  • Candidates for security course in the Ministry of Defense

排除标准

  • Cardiopulmonary diseases (e.g., recent myocardial infarction or unstable angina)
  • Musculoskeletal or neuromuscular impairments that preclude exercise training
  • Cognitive impairments
  • Use of drugs that affect bone or muscle metabolism (mainly steroids)

研究组 & 干预措施

A lower exercise volume group

Active Comparator

They will conduct 85% of the control group weekly training volume (i.e., 30h/week)

干预措施: A lower exercise volume group (Behavioral)

A longer rest group

Active Comparator

They will maintain the 35 h/week of exercise training, but with longer rest between exercise sessions

干预措施: A longer rest group (Behavioral)

A regular training volume

Active Comparator

They will maintain their training volume of 35 h/week

干预措施: A regular training volume (Behavioral)

结局指标

主要结局

Changes in endocrine measurements

时间窗: At baseline and at 8 weeks of intervention

Testosterone (ng/dL)

Changes in immune system

时间窗: At baseline and at 8 weeks of intervention

Tumor necrosis factor-a (pg/ml), Interleukin-6 (pg/ml)

Changes in cardiometabolic measurements

时间窗: At baseline and at 8 weeks of intervention

Glucose (mg/dl), lipid profile (total cholesterol in mg/dl, HDL in mg/dl, LDL in mg/dl)

次要结局

  • Changes in aerobic capacity(At baseline and at 8 weeks of intervention)
  • Changes in body composition(At baseline and at 8 weeks of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gepner Yftach

Principal Investigator - Ph.D.

Tel Aviv University

研究点 (2)

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