NCT01907841

Brief Summary

Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle damage and changes in muscle function; this is known as exercise-induced muscle damage (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as in various other organs. Therefore the purpose of this study is to:

  1. 1.Quantify the use of IPC in recovery following EIMD.
  2. 2.Identify any effect of IPC during recovery on muscle function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

July 15, 2013

Last Update Submit

March 5, 2014

Conditions

Keywords

Investigate IPC on EIMD

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in maximal voluntary contraction

    Isometric MVC of the participants' dominant knee extensors was assessed using a strain gauge. MVCs were performed for 3 s with a 60 s rest between each repetition. The change in MVC will be determined 24, 48 and 72 hours following pre exercise conditions.

    pre exercise, 24 hours post, 48 hours post and 72 hours post exercise

Secondary Outcomes (4)

  • Change from baseline in Creatine kinase

    pre exercise, 24 hours post, 48 hours post and 72 hours post exercise

  • Change from baseline in Limb girth

    pre exercise, 24 hours post, 48 hours post and 72 hours post exercise

  • Chnage from baseline in Vertical jump

    pre exercise, 24 hours post, 48 hours post and 72 hours post exercise

  • Change from baseline in Muscle soreness

    pre exercise, 24 hours post, 48 hours post and 72 hours post exercise

Study Arms (2)

Ischemic Preconditioning

EXPERIMENTAL

IPC (4 x 5 minute cycles @ 220 mmHg) with 5 min reperfusion between trials.

Other: Ischemic Preconditioning

Ischemic Preconditioning Placebo

PLACEBO COMPARATOR

Placebo (4 x 5 minute cycles @ 20mmHg) with 5 minutes between each cycle

Other: Ischemic Preconditioning

Interventions

Ischemic PreconditioningIschemic Preconditioning Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically Active Males

You may not qualify if:

  • Muscular skeletal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Marys Umiversity College

London, TW1 4SX, United Kingdom

Location

MeSH Terms

Interventions

Ischemic Preconditioning

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer Exercise Physiology

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 25, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations