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

Exercise Clinical Trial

— MOD_2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893641
• Other study ID #: 0006524-1
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Exercise
• Recovery

Intervention

Behavioral:
• A regular training volume
Participate will maintain their training volume of 35 h/week
• A lower exercise volume group
Participate will conduct 85% of the control group weekly training volume (i.e., 30h/week)
• A longer rest group
Participate will maintain the 35 h/week of exercise training

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv	Other

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in explosive power	Countermovement jump (in cm)	At baseline and at 4 and 8 weeks of intervention
Other	Strength assessment	Maximum voluntary contraction (in Newton)	At baseline and at 4 and 8 weeks of intervention
Other	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
Other	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
Primary	Changes in immune system	Tumor necrosis factor-a (pg/ml), Interleukin-6 (pg/ml)	At baseline and at 8 weeks of intervention
Primary	Changes in immune system	C-Reactive protein (mg/dl)	At baseline and at 8 weeks of intervention
Primary	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
Primary	Changes in endocrine measurements	Testosterone (ng/dL)	At baseline and at 8 weeks of intervention
Primary	Changes in endocrine measurements	Growth hormone (ng/mL), Insulin-like growth factor 1 (ng/mL)	At baseline and at 8 weeks of intervention
Secondary	Changes in aerobic capacity	Wingate test (watts)	At baseline and at 8 weeks of intervention
Secondary	Changes in aerobic capacity	Maximal O2 uptake (ml/kg/min)	At baseline and at 8 weeks of intervention
Secondary	Changes in body composition	BMI (kg/m^2)	At baseline and at 8 weeks of intervention
Secondary	Changes in body composition	waist circumference (cm)	At baseline and at 8 weeks of intervention
Secondary	Changes in body composition	Fat-free mass (kg)	At baseline and at 8 weeks of intervention