ExercisePhase 3MOD_2NCT05893641
Investigate the Relationship Between Exercise Training and Recovery Ratio to Improve Physical Performance and Health Status
A Phase 3 study testing A regular training volume, A lower exercise volume group and A longer rest group in people with Exercise and Recovery, run by Tel Aviv University at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- A regular training volume, A lower exercise volume group and A longer rest group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2023to Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Highly active participants
- Healthy
- Candidates for security course in the Ministry of Defense
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv, Other, 6997801
Yftach Gepner, PhD, +972733804726, gepner@tauex.tau.ac.il
About this study
Official title: 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.
Read more
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).
Read the 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.
- Being tested
- A regular training volume, A lower exercise volume group, A longer rest group
- Keywords
- Recovery, Exercise training, Performance, Cardiometabolic health, Immune response
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A regular training volumeBehavioural
Participate will maintain their training volume of 35 h/week
A lower exercise volume groupBehavioural
Participate will conduct 85% of the control group weekly training volume (i.e., 30h/week)
A longer rest groupBehavioural
Participate will maintain the 35 h/week of exercise training
| Study group | Role | What they receive |
|---|---|---|
| A regular training volume | Active comparator | They will maintain their training volume of 35 h/week Receives: Behavioral: A regular training volume |
| A lower exercise volume group | Active comparator | They will conduct 85% of the control group weekly training volume (i.e., 30h/week) Receives: Behavioral: A lower exercise volume group |
| A longer rest group | Active comparator | They will maintain the 35 h/week of exercise training, but with longer rest between exercise sessions Receives: Behavioral: A longer rest group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in immune system
Tumor necrosis factor-a (pg/ml), Interleukin-6 (pg/ml)
Measured: At baseline and at 8 weeks of intervention
Changes in immune system
C-Reactive protein (mg/dl)
Measured: 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)
Measured: At baseline and at 8 weeks of intervention
Changes in endocrine measurements
Testosterone (ng/dL)
Measured: At baseline and at 8 weeks of intervention
Changes in endocrine measurements
Growth hormone (ng/mL), Insulin-like growth factor 1 (ng/mL)
Measured: At baseline and at 8 weeks of intervention
Secondary outcomes (5)
Changes in aerobic capacity
Wingate test (watts)
Measured: At baseline and at 8 weeks of intervention
Changes in aerobic capacity
Maximal O2 uptake (ml/kg/min)
Measured: At baseline and at 8 weeks of intervention
Changes in body composition
BMI (kg/m^2)
Measured: At baseline and at 8 weeks of intervention
Changes in body composition
waist circumference (cm)
Measured: At baseline and at 8 weeks of intervention
Changes in body composition
Fat-free mass (kg)
Measured: At baseline and at 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gepner Yftach, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893641
- Sponsor's protocol ID
- 0006524-1
- Acronym
- MOD_2
- Status last verified
- Feb 2024
- First submitted
- 9 May 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Relationship Between Exercise Training and Recovery to Improve Physical Performance and Health Indices
- ClinicalTrials.gov ID
- NCT05893641
- Acronym / sponsor ID
- MOD_2 / 0006524-1
- Keywords
- Recovery, Exercise training, Performance, Cardiometabolic health, Immune response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A regular training volume | Active comparator | Behavioral: A regular training volumeThey will maintain their training volume of 35 h/week |
| A lower exercise volume group | Active comparator | Behavioral: A lower exercise volume groupThey will conduct 85% of the control group weekly training volume (i.e., 30h/week) |
| A longer rest group | Active comparator | Behavioral: A longer rest groupThey will maintain the 35 h/week of exercise training, but with longer rest between exercise sessions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Highly active participants
- Healthy
- Candidates for security course in the Ministry of Defense
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A regular training volumeParticipate will maintain their training volume of 35 h/week | Behavioural | A regular training volume |
| A lower exercise volume groupParticipate will conduct 85% of the control group weekly training volume (i.e., 30h/week) | Behavioural | A lower exercise volume group |
| A longer rest groupParticipate will maintain the 35 h/week of exercise training | Behavioural | A longer rest group |
Primary outcome
Changes in immune system
Time frame: At baseline and at 8 weeks of intervention
Tumor necrosis factor-a (pg/ml), Interleukin-6 (pg/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)
Changes in endocrine measurements
Time frame: At baseline and at 8 weeks of intervention
Testosterone (ng/dL)
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)
5 secondary outcomes
Changes in aerobic capacity
Time frame: At baseline and at 8 weeks of intervention
Changes in aerobic capacity
Time frame: At baseline and at 8 weeks of intervention
Changes in body composition
Time frame: At baseline and at 8 weeks of intervention
Changes in body composition
Time frame: At baseline and at 8 weeks of intervention
Changes in body composition
Time frame: At baseline and at 8 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A regular training volume, A lower exercise volume group and A longer rest group in people with Exercise and Recovery, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yftach Gepner, PhD (+972733804726, gepner@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in immune system (time frame: At baseline and at 8 weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.