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Clinical Trials/NCT05893641
NCT05893641
Recruiting
Phase 3

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

Tel Aviv University1 site in 1 country200 target enrollmentJune 1, 2023

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Exercise
Sponsor
Tel Aviv University
Enrollment
200
Locations
1
Primary Endpoint
Changes in endocrine measurements
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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).

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
July 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gepner Yftach

Principal Investigator - Ph.D.

Tel Aviv University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Changes in endocrine measurements

Time Frame: At baseline and at 8 weeks of intervention

Growth hormone (ng/mL), Insulin-like growth factor 1 (ng/mL)

Changes in immune system

Time Frame: At baseline and at 8 weeks of intervention

C-Reactive protein (mg/dl)

Changes in cardiometabolic measurements

Time Frame: 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)

Secondary Outcomes

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

Study Sites (1)

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