NCT04025723

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

July 9, 2019

Last Update Submit

March 24, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 .

    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 .

    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 .

    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 .

    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)

    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)

    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)

    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)

    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)

    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

  • +8 more secondary outcomes

Study Arms (2)

Young

ACTIVE COMPARATOR

men aged between 18 to 30 years old

Other: Downhill running

Middle-aged

ACTIVE COMPARATOR

men aged between 35 to 50 years old

Other: Downhill running

Interventions

60 minutes downhill running in 10% grade, in an effort of 65% of VO2max.

Middle-agedYoung

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Young (18-30 y) and middle aged (35-50 y) men will perform 60 min of downhill running
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 19, 2019

Study Start

February 20, 2020

Primary Completion

January 16, 2021

Study Completion

January 16, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations