ExerciseNCT04025723
Differences in Rate of Recovery Between Young and Middle-aged Men After Downhill Running
A study testing Downhill running in people with Exercise, run by Gepner Yftach at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Downhill running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Feb 2020to 16 Jan 2021
- Phase
- Interventional
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active man which perform a minimum of 150 minutes/week of exercise
- Able to complete 60 min run.
Who cannot join
- Injuries in lower body
- cardio-respiratory disease
- supplementing with performance enhancing supplements
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Exercise
- Being tested
- Downhill running
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Downhill runningOther
60 minutes downhill running in 10% grade, in an effort of 65% of VO2max.
| Study group | Role | What they receive |
|---|---|---|
| Young | Active comparator | men aged between 18 to 30 years old Receives: Other: Downhill running |
| Middle-aged | Active comparator | men aged between 35 to 50 years old Receives: Other: Downhill running |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 outcomes (13)
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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start20 Feb 2020
- Primary completion16 Jan 2021
- Study completion16 Jan 2021
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Young (18-30 y) and middle aged (35-50 y) men will perform 60 min of downhill running
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gepner Yftach
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gepner Yftach, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025723
- Sponsor's protocol ID
- Recovery
- Status last verified
- Mar 2021
- First submitted
- 9 Jul 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Rate of Recovery Between Young and Middle-aged Men After Downhill Running
- ClinicalTrials.gov ID
- NCT04025723
- Acronym / sponsor ID
- Recovery
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gepner YftachUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 16 Jan 2021 (actual)
- Study completion
- 16 Jan 2021 (actual)
- First posted
- 19 Jul 2019 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Young (18-30 y) and middle aged (35-50 y) men will perform 60 min of downhill running
| Arm | Type | Receives |
|---|---|---|
| Young | Active comparator | Other: Downhill runningmen aged between 18 to 30 years old |
| Middle-aged | Active comparator | Other: Downhill runningmen aged between 35 to 50 years old |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Active man which perform a minimum of 150 minutes/week of exercise
- Able to complete 60 min run.
Key exclusion criteria (3 listed)
- Injuries in lower body
- cardio-respiratory disease
- supplementing with performance enhancing supplements
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 |
|---|---|---|
| Downhill running60 minutes downhill running in 10% grade, in an effort of 65% of VO2max. | Other | Middle-aged, Young |
Primary outcome
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 .
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 .
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 .
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 .
13 secondary outcomes
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
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
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
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
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
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
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.
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.
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.
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 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 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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Downhill running in people with Exercise, run by Gepner Yftach 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Mar 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 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 25 Mar 2021.