NCT03717948

Brief Summary

This crossover study investigates the effects of restricting arterial blood flow during cycling exercise on PGC-1α and its upstream signalling pathways. In a randomized order, participants will exercise once for 30 minutes with restricted blood flow and then will exercise once for 30 minutes with no blood flow restriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

October 19, 2018

Last Update Submit

July 11, 2019

Conditions

Keywords

Acute ExerciseMitochondriaSkeletal MusclePGC1αMitochondrial BiogenesisIntracellular Signalling

Outcome Measures

Primary Outcomes (1)

  • Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA)

    Fold-change in PGC-1α mRNA expression

    15 minutes before exercise and 3 hours post-exercise for both exercise sessions

Secondary Outcomes (10)

  • Catecholamine concentrations

    15 minutes before exercise and immediately post-exercise for both exercise sessions

  • Total and phosphorylated p38 mitogen-activated protein kinase (MAPK)

    15 minutes before exercise and immediately post-exercise for both exercise sessions

  • Total and phosphorylated acetyl coenzyme A carboxylase (ACC)

    15 minutes before exercise and immediately post-exercise for both exercise sessions

  • Total and phosphorylated protein kinase A (PKA)

    15 minutes before exercise and immediately post-exercise for both exercise sessions

  • Acetylated p53

    15 minutes before exercise and immediately post-exercise for both exercise sessions

  • +5 more secondary outcomes

Study Arms (2)

CTL - BFR

EXPERIMENTAL

CTL Exercise then BFR Exercise

Other: BFR ExerciseOther: CTL Exercise

BFR - CTL

EXPERIMENTAL

BFR Exercise then CTL Exercise

Other: BFR ExerciseOther: CTL Exercise

Interventions

Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).

BFR - CTLCTL - BFR

Participants will exercise on a recumbent bike placed on flat ground (CTL).

BFR - CTLCTL - BFR

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • hours of physical activity per week
  • No previous cycling training
  • No concurrent involvement in another training program
  • Body mass index \< 30 kg/m2

You may not qualify if:

  • Presence of cardiovascular disease
  • Presence of metabolic disease
  • Taking regular oral medication
  • Current smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L3N6, Canada

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Brendon J Gurd, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation concealment, assessor blinding
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 19, 2018

First Posted

October 24, 2018

Study Start

October 1, 2018

Primary Completion

January 28, 2019

Study Completion

January 28, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations