Differences in Rate of Recovery Between Young and Middle-aged Men After Downhill Running

March 24, 2021 updated by: Gepner Yftach
The aim of this study is to evaluate differences in rate of recovery between young and middle-aged men after prolonged (downhill) running. Thirty healthy young (n=15, 18-30 y) and middle-aged (n=15, 35-50y) men will be recruited for this study. Participants will perform 60 minutes of downhill run at 65% of their maximal oxygen consumption (VO2max). Recovery parameters will be evaluated during 48 hours following the downhill protocol, and will include changes in performance tests, inflammatory markers, muscle integrity and heart-rate variability. Questioners will be used to evaluate muscle soreness and fatigue. We hypothesized that middle-aged males will have longer rate of recovery following the downhill running protocol, as compared to younger age males.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Active man which perform a minimum of 150 minutes/week of exercise
  • Able to complete 60 min run.

Exclusion Criteria:

  • Injuries in lower body
  • cardio-respiratory disease
  • supplementing with performance enhancing supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Young
men aged between 18 to 30 years old
Other: Downhill running
60 minutes downhill running in 10% grade, in an effort of 65% of VO2max.
ACTIVE_COMPARATOR: Middle-aged
men aged between 35 to 50 years old
Other: Downhill running
60 minutes downhill running in 10% grade, in an effort of 65% of VO2max.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes over time in Maximal voluntary contraction (MVC) of the Musculus quadriceps femoris
Time Frame: MVC will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
MVC (kg) measures the greatest amount of tension a muscle can generate and hold. We will measure it before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in MVC over time will be made between the two study's arms .
MVC will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in vertical jump (VJ)
Time Frame: VJ will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
VJ (cm) is the height achieved after a vertical jump.We will measure it before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in VJ over time will be made between the two study's arms .
VJ will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in stride length
Time Frame: Stride length will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Stride length (cm) is the distance achieved while walking or running and is calculated as the distance from the toe of your right foot (starting position) to the toe of your right foot (ending position). Participants will run on a treadmill with pressure sensors for 2 minutes. We will measure stride length before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in stride length over time will be made between the two study's arms .
Stride length will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in stride frequency
Time Frame: Stride frequency will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Stride frequency (strides per minutes) is the number of times a single foot hits the ground while walking or running. Participants will run on a treadmill with pressure sensors for 2 minutes. We will measure stride frequency before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in stride frequency over time will be made between the two study's arms .
Stride frequency will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes over time in the concentration of circulating interleukin -6 (IL-6)
Time Frame: The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Concentration of circulating IL-6 (pg/ml) will be measured before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in concentration of circulating IL-6 over time will be made between the two study's arms .
The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in the concentration of circulating interleukin -10 (IL-10)
Time Frame: The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Concentration of circulating IL-10 (pg/ml) will be measured before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in concentration of circulating IL-6 over time will be made between the two study's arms .
The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in the concentration of circulating interleukin -1 receptor antagonist (IL-1ra)
Time Frame: The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Concentration of circulating IL-1ra (pg/ml) will be measured before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in concentration of circulating IL-6 over time will be made between the two study's arms .
The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in the concentration of circulating tumor necrosis factor alpha (TNFa)
Time Frame: The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Concentration of circulating TNFa (pg/ml) will be measured before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in concentration of circulating IL-6 over time will be made between the two study's arms .
The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in the concentration of circulating c-reactive protein (CRP)
Time Frame: The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Concentration of circulating CRP (nmol/L) will be measured before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in concentration of circulating IL-6 over time will be made between the two study's arms .
The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in the concentration of circulating creatine kinase (CK)
Time Frame: The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Concentration of circulating CK (IU/L) will be measured before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in concentration of circulating IL-6 over time will be made between the two study's arms .
The circulating parameters will be measured before and after 30, 60, 120 minutes (Day 0), 24 (Day 1) and 48 hours (Day 2) after the downhill running
Changes over time in the concentration of circulating lactate dehydrogenase (LDH)
Time Frame: The circulating parameters will be measured before intervention, immediately after, 30, 60, 120 minutes, 24 and 48 h post intervention.
Concentration of circulating LDH (IU/L) will be measured before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in concentration of circulating IL-6 over time will be made between the two study's arms .
The circulating parameters will be measured before intervention, immediately after, 30, 60, 120 minutes, 24 and 48 h post intervention.
Changes over time in muscle fibers morphology
Time Frame: MRI will be conducted up to 1 week before the intervention (screening day, Day -1) and after 24 hours (Day 1) or 48 hours (Day 2) post downhill running.
Muscle fibers morphology of the Musculus quadriceps femoris will be assessed by Diffusion Tensor Imaging by magnetic resonance imaging (MRI). We will assess muscle fiber morphology before (baseline) and 48 hours after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in muscle fiber morphology over time will be made between the two study's arms .
MRI will be conducted up to 1 week before the intervention (screening day, Day -1) and after 24 hours (Day 1) or 48 hours (Day 2) post downhill running.
Changes over time in delayed-onset muscle soreness (DOMS)
Time Frame: DOMS will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
DOMS will be evaluated using the Visual Analogue Scale (VAS). The VAS scale will be 150 mm line with "no pain" on one side and "maximal pain" on the other. Each participant will mark a line based on his soreness in the Musculus quadriceps femoris and Musculus gastrocnemius. The distance (mm) from the "no pain" side will be measured. DOMS assessment will be made before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point.
DOMS will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
Changes over time in Mood States
Time Frame: Changes in Mood States will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
Changes in mood state will be assessed using the Profile of Mood States questioner (POMS). POMS is a validated questioners comprised from 58 feelings and emotions. For each parameter, the participants will be asked how he feels right know and select a value ranging between 0 to 4, where "0" means "not at all" and "4" means "extremely". A Total Mood Disturbance (TMD) score is calculated by summing the totals for the negative sub-scales and then subtracting the totals for the positive sub-scales.
Changes in Mood States will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
Changes over time in total fatigue
Time Frame: Changes in total fatigue will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
Changes in total fatigue will be assessed using the Rating Of Fatigue scale (ROF). ROF is a validated 11-point numerical scale ranging from zero to ten. Participants will be asked to rate how fatigued they feel whereas, "0" is "not fatigued at all" and "10" is "Total fatigue and exhaustion- nothing left". Total fatigue assessment will be made before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point.
Changes in total fatigue will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
Changes over time in none-specific muscle fatigue- MVC of the forearm
Time Frame: None-specific muscle fatigue tests will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
We will measure none-specific muscle fatigue using hand gripper to evaluate the forearm MVC (kg). We will measure it before (baseline) and after the downhill running protocol. Changes from baseline will be calculated for each time point. A comparison of the changes in MVC over time will be made between the two study's arms .
None-specific muscle fatigue tests will be measured before intervention, immediately after, 30, 60, 120 minutes after (Day 0), 24 hours (Day 1) and 48 hours (Day 2) post downhill running.
Changes over time in heart rate variability (HRV)
Time Frame: Between 3 to 5 days before screening day (Day -1) and downhill running (Day 0) for baseline assessment, and after the downhill running (Day 0) until day 2
HRV (ms) quantifies the variability between heart beats. We will use the time-based analysis and the root mean square of successive differences of R-R intervals (RMSSD) value. The measurements will be done continuously with a heart rate monitor. Baseline measurements will be done for 3 to 5 days before the downhill running and the average value will be defined as "baseline HRV". Changes in HRV will be measured continuously in the 48 hours following the running. Percentage from "baseline HRV" will be calculated and compared between the two study's arms.
Between 3 to 5 days before screening day (Day -1) and downhill running (Day 0) for baseline assessment, and after the downhill running (Day 0) until day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gepner Yftach

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECOVERY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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