NCT03482726

Brief Summary

This study will utilize a combination of cardiovascular analysis, 3D motion capture, and a software package, Metrifit, to monitor measures of well-being to comprehensively evaluate both the musculoskeletal and physiological responses following a HIIT training intervention at EOC as a means of improving performance and potentially reducing injury risk factors. This holistic approach of physiological and biomechanical factors is unprecedented. This is the first interventional study to determine the effect of high intensity training at EOC on cardiovascular performance, kinematics and well-being which may minimize risk of injury factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

December 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

November 22, 2017

Last Update Submit

December 23, 2019

Conditions

Keywords

bicyclecadencecyclistmodulation

Outcome Measures

Primary Outcomes (7)

  • Time to exhaustion T(max)

    time to reach exhaustion

    Baseline

  • Ventilatory threshold (VT)

    Baseline

  • Maximal cardiac output

    Baseline

  • Maximal stroke volume

    Baseline

  • decreased trunk lean

    decrease in degree of lean in truck

    Baseline

  • decreased ankle dorsiflexion

    decrease in amount of ankle dorsiflexion

    Baseline

  • decreased knee splay

    decreased degree of knee splay

    Baseline

Secondary Outcomes (8)

  • Improved VO2 max

    6 weeks

  • Increased O2 consumption at VT

    6 weeks

  • Time to VT

    6 weeks

  • Time to T(max)

    6 weeks

  • decreased trunk lean

    6 weeks

  • +3 more secondary outcomes

Study Arms (1)

Cycling Cadence Modulation

OTHER

3 initial visits to collect baseline information; 6-week HIIT indoor cycling program at the individual prescribed cadence; final study visit for post-intervention measures.

Behavioral: Cycling Cadence Modulation

Interventions

6-week high intensity training (HIIT) indoor cycling program, described later, at their prescribed cadence (FCC or EOC), using cadence meters.

Cycling Cadence Modulation

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An experienced cyclist will be defined as one with at least 5 years of cycling experience and 5000 miles of training on a road bike with a clipless pedal system.
  • Able to tolerate strenuous, maximal exercise and comply with a 6 week training protocol
  • Have access to an indoor trainer or spin bike with a cadence sensor in order to train 3 times per week for 60 minutes

You may not qualify if:

  • Taking medication which could impact cardiovascular function or performance (stimulants, beta-blockers, e.g.)
  • Significant cardiac or pulmonary disease (congenital cardiac disease, uncontrolled hypertension, uncontrolled asthma, e.g.)
  • Musculoskeletal injuries that preclude a maximal cycling effort and participation in training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Study Officials

  • Andrew M Watson, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

March 29, 2018

Study Start

June 26, 2017

Primary Completion

April 2, 2019

Study Completion

April 2, 2019

Last Updated

December 26, 2019

Record last verified: 2019-04

Locations