An interventional study of Downhill running in Exercise, sponsored by Gepner Yftach. Completed at 1 site in Israel. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by Gepner Yftach · Not applicable, Interventional, and Diagnostic
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.
Gepner Yftach is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
men aged between 18 to 30 years old
Other: Downhill running
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.
Changes over time in Maximal voluntary contraction (MVC) of the Musculus quadriceps femoris
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 .
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
Changes over time in vertical jump (VJ)
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 .
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
Changes over time in stride length
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 .
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
Changes over time in stride frequency
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 .
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
Changes over time in the concentration of circulating interleukin -6 (IL-6)
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 .
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
Changes over time in the concentration of circulating interleukin -10 (IL-10)
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 .
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
Changes over time in the concentration of circulating interleukin -1 receptor antagonist (IL-1ra)
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 .
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
Changes over time in the concentration of circulating tumor necrosis factor alpha (TNFa)
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 .
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
Changes over time in the concentration of circulating c-reactive protein (CRP)
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 .
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
Changes over time in the concentration of circulating creatine kinase (CK)
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 .
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
Changes over time in the concentration of circulating lactate dehydrogenase (LDH)
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 .
Time frame: 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
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 .
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.
Changes over time in delayed-onset muscle soreness (DOMS)
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.
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.
Changes over time in Mood States
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.
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 over time in total fatigue
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.
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 over time in none-specific muscle fatigue- MVC of the forearm
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 .
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.
Changes over time in heart rate variability (HRV)
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.
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
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Gepner Yftach