Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05893641 |
Other study ID # |
0006524-1 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
June 1, 2023 |
Est. completion date |
July 2025 |
Study information
Verified date |
February 2024 |
Source |
Tel Aviv University |
Contact |
Yftach Gepner, PhD |
Phone |
+972733804726 |
Email |
gepner[@]tauex.tau.ac.il |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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).
Description:
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.