Clinical trial NCT05893641: Investigate the Relationship Between Exercise Training and Recovery Ratio to Improve Physical Performance and Health Status
Official title: Investigate the Relationship Between Exercise Training and Recovery to Improve Physical Performance and Health Indices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Exercise
Recovery
Keywords: Recovery
Exercise training
Performance
Cardiometabolic health
Immune response
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in immune system
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in immune system
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in cardiometabolic measurements
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in endocrine measurements
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in endocrine measurements
timeFrame: At baseline and at 8 weeks of intervention
Secondary outcomes:
measure: Changes in aerobic capacity
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in aerobic capacity
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in body composition
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in body composition
timeFrame: At baseline and at 8 weeks of intervention
measure: Changes in body composition
timeFrame: At baseline and at 8 weeks of intervention
Other outcomes:
measure: Changes in explosive power
timeFrame: At baseline and at 4 and 8 weeks of intervention
measure: Strength assessment
timeFrame: At baseline and at 4 and 8 weeks of intervention
measure: Nutritional intake
timeFrame: At week 2 and week 6 of intervention
measure: Nutritional intake
timeFrame: At week 2 and week 6 of intervention
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
state: Other
Study officials:
References: