Investigate the Relationship Between Exercise Training and Recovery Ratio to Improve Physical Performance and Health Status (MOD_2)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Exercise; Recovery
• Intervention / Treatment: Behavioral: A regular training volume; Behavioral: A lower exercise volume group; Behavioral: A longer rest group

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yftach Gepner, PhD; Phone Number: +972733804726; Email: gepner@tauex.tau.ac.il

Study Locations

• Israel
  • Other
    • Tel Aviv, Other, Israel, 6997801
      • Recruiting
      • Tel Aviv University
      • Contact: Yftach Gepner, PhD; Phone Number: +972733804726; Email: gepner@tauex.tau.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Highly active participants
• Healthy
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A regular training volume; They will maintain their training volume of 35 h/week	Behavioral: A regular training volume; Participate will maintain their training volume of 35 h/week
Active Comparator: A lower exercise volume group; They will conduct 85% of the control group weekly training volume (i.e., 30h/week)	Behavioral: A lower exercise volume group; Participate will conduct 85% of the control group weekly training volume (i.e., 30h/week)
Active Comparator: A longer rest group; They will maintain the 35 h/week of exercise training, but with longer rest between exercise sessions	Behavioral: A longer rest group; Participate will maintain the 35 h/week of exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in immune system	Tumor necrosis factor-a (pg/ml), Interleukin-6 (pg/ml)	At baseline and at 8 weeks of intervention
Changes in immune system	C-Reactive protein (mg/dl)	At baseline and at 8 weeks of intervention
Changes in cardiometabolic measurements	Glucose (mg/dl), lipid profile (total cholesterol in mg/dl, HDL in mg/dl, LDL in mg/dl)	At baseline and at 8 weeks of intervention
Changes in endocrine measurements	Testosterone (ng/dL)	At baseline and at 8 weeks of intervention
Changes in endocrine measurements	Growth hormone (ng/mL), Insulin-like growth factor 1 (ng/mL)	At baseline and at 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in aerobic capacity	Wingate test (watts)	At baseline and at 8 weeks of intervention
Changes in aerobic capacity	Maximal O2 uptake (ml/kg/min)	At baseline and at 8 weeks of intervention
Changes in body composition	BMI (kg/m^2)	At baseline and at 8 weeks of intervention
Changes in body composition	waist circumference (cm)	At baseline and at 8 weeks of intervention
Changes in body composition	Fat-free mass (kg)	At baseline and at 8 weeks of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in explosive power	Countermovement jump (in cm)	At baseline and at 4 and 8 weeks of intervention
Strength assessment	Maximum voluntary contraction (in Newton)	At baseline and at 4 and 8 weeks of intervention
Nutritional intake	protein intake (gr and in %of total kcal), carbohydrate intake (gr and in% of total kcal), fat intake (gr and in %of total kcal).	At week 2 and week 6 of intervention
Nutritional intake	Will be assessed by validated questionnaires such as a food diary. Macronutrients composition will be measured from the self-reported nutritional intake: daily intake (kcal)	At week 2 and week 6 of intervention

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Recovery; Performance; Exercise training; Immune response; Cardiometabolic health
• Other Study ID Numbers: 0006524-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No