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

Sponsor
Tel Aviv University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05893641
Collaborator
(none)
200
3
25

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A regular training volume
  • Behavioral: A lower exercise volume group
  • Behavioral: A longer rest group
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Investigate the Relationship Between Exercise Training and Recovery to Improve Physical Performance and Health Indices
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in immune system [At baseline and at 8 weeks of intervention]

    Tumor necrosis factor-a (pg/ml), Interleukin-6 (pg/ml)

  2. Changes in immune system [At baseline and at 8 weeks of intervention]

    C-Reactive protein (mg/dl)

  3. Changes in cardiometabolic measurements [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)

  4. Changes in endocrine measurements [At baseline and at 8 weeks of intervention]

    Testosterone (ng/dL)

  5. Changes in endocrine measurements [At baseline and at 8 weeks of intervention]

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

Secondary Outcome Measures

  1. Changes in aerobic capacity [At baseline and at 8 weeks of intervention]

    Wingate test (watts)

  2. Changes in aerobic capacity [At baseline and at 8 weeks of intervention]

    Maximal O2 uptake (ml/kg/min)

  3. Changes in body composition [At baseline and at 8 weeks of intervention]

    BMI (kg/m^2)

  4. Changes in body composition [At baseline and at 8 weeks of intervention]

    waist circumference (cm)

  5. Changes in body composition [At baseline and at 8 weeks of intervention]

    Fat-free mass (kg)

Other Outcome Measures

  1. Changes in explosive power [At baseline and at 4 and 8 weeks of intervention]

    Countermovement jump (in cm)

  2. Strength assessment [At baseline and at 4 and 8 weeks of intervention]

    Maximum voluntary contraction (in Newton)

  3. Nutritional intake [At week 2 and week 6 of intervention]

    protein intake (gr and in %of total kcal), carbohydrate intake (gr and in% of total kcal), fat intake (gr and in %of total kcal).

  4. Nutritional intake [At week 2 and week 6 of intervention]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tel Aviv University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gepner Yftach, Principal Investigator - Ph.D., Tel Aviv University
ClinicalTrials.gov Identifier:
NCT05893641
Other Study ID Numbers:
  • 0006524-1
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gepner Yftach, Principal Investigator - Ph.D., Tel Aviv University

Study Results

No Results Posted as of Jun 8, 2023