NCT03317704

Brief Summary

This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable healthy

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

October 3, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 25, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

October 3, 2017

Last Update Submit

September 9, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Quadriceps endurance

    Time to exhaustion during knee-extensor exercise

    Change from before (baseline) to after 6 weeks of training (Week 6)

Secondary Outcomes (1)

  • K+ release

    Change from before (baseline) to after 6 weeks of training (Week 6)

Other Outcomes (5)

  • Femoral venous plasma K+

    Change from before (baseline) to after 6 weeks of training (Week 6)

  • Femoral venous lactate

    Change from before (baseline) to after 6 weeks of training (Week 6)

  • Muscle Na+/K+-ATPase subunit content

    Change from before (baseline) to after 6 weeks of training (Week 6)

  • +2 more other outcomes

Study Arms (3)

speed endurance training (SET)

ACTIVE COMPARATOR

Training 6 weeks 3 times pr. week

Behavioral: Speed endurance training

Controls

NO INTERVENTION

Asked to continue their usual life style

speed endurance training (SET) II

ACTIVE COMPARATOR

Training 6 weeks 3 times pr. week

Behavioral: Speed endurance training

Interventions

Speed endurance trainingBEHAVIORAL

Speed endurance training

speed endurance training (SET)speed endurance training (SET) II

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • ml/kg/min
  • BMI 19-26 kg/m2
  • Normal ECG (assessed by MD)

You may not qualify if:

  • Allergic to n-acetylcystine (NAC) or digoxin
  • Severe side effects from NAC or digoxin
  • Chronic diseases (assessed by MD to be a potential hazard or to interfere with outcome measures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 23, 2017

Study Start

October 25, 2017

Primary Completion

December 18, 2019

Study Completion

May 20, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

DK(1)