NCT04151095

Brief Summary

This parallel-arm trial study investigates the effects of restricting arterial blood flow during cycling exercise on citrate synthase. Participants will be randomized to either a blood flow restricted or non-blood flow restricted exercise training group. Both groups will complete seven, 30-minute exercise sessions over a 14-day period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

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

First Submitted

Initial submission to the registry

April 2, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

April 2, 2019

Last Update Submit

December 19, 2023

Conditions

Keywords

MitochondriaExercise trainingVO2Aerobic exerciseCitrate SynthaseBlood flow restriction

Outcome Measures

Primary Outcomes (1)

  • Citrate Synthase

    Fold change in citrate synthase maximal activity

    3 days prior to start of exercise training and 3 days after completing exercise training

Secondary Outcomes (11)

  • Transcription factor A, mitochondrial (TFAM)

    3 days before training to 3 days after training

  • Nuclear respiratory factor, 1 (NRF1)

    3 days before training to 3 days after training

  • Maximal oxygen consumption (VO2peak)

    3 days before training to 3 days after training

  • Heart rate (HR)

    Every 5 minutes during each of the 7, 30-minute exercise sessions

  • Revolutions per minute (RPM)

    Every 5 minutes during each of the 7, 30-minute exercise sessions

  • +6 more secondary outcomes

Study Arms (2)

BFR

EXPERIMENTAL
Other: BFR Exercise Training

CTL

EXPERIMENTAL
Other: CTL Exercise Training

Interventions

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

BFR

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

CTL

Eligibility Criteria

Age18 Years - 30 Years
Sexall
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

Related Publications (1)

  • Preobrazenski N, Mladen SPS, Causer E, Menezes E, Islam H, Drouin PJ, Tschakovsky ME, Gurd BJ. Mitochondrial and cardiovascular responses to aerobic exercise training in supine and upright positions in healthy young adults: a randomized parallel arm trial. Transl Exerc Biomed. 2025 Mar 26;2(1):9-20. doi: 10.1515/teb-2025-0002. eCollection 2025 May.

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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 2, 2019

First Posted

November 5, 2019

Study Start

May 6, 2019

Primary Completion

December 13, 2019

Study Completion

December 13, 2019

Last Updated

December 26, 2023

Record last verified: 2023-12

Locations