HealthyNCT03482726
Cadence Modulation to Improve Well-Being, Kinematics and Aerobic Performance in Cyclists
A study testing Cycling Cadence Modulation in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cycling Cadence Modulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In the first session, each individual will be asked to fill out a questionnaire to regarding cycling experience, prior bike fits (with data sheets when available), and injury history. Maximal aerobic capacity (VO2max) will be determined. During the test, subjects will be asked rate exertion. Before testing, the system will be calibrated with known oxygen and carbon dioxide concentrations. During the test, subjects will be asked to breathe normally through a low dead space bidirectional turbine. Inspired and expired gases will be analyzed for concentrations of O2 and CO2, to determine alveolar gas exchange. Total ventilation (VE), respiratory rate, oxygen consumption (VO2), carbon dioxide (VCO2) will be measured, and respiratory exchange ratio (RER; VCO2/VO2) will be calculated continuously during the test and expressed as a 30-second rolling average.
Participants will return 48 hours later, at which time EOC will be determined after a moderate intensity prolonged cycling exercise (PCE) at seven different cadences. Cadences from 50rpm to 110rpm will be randomly generated and introduced every 3 minutes, followed by a 3 minute cool down at FCC at 40% PP (Figure Subjects will then be pair matched by gender and randomized into control (FCC) or EOC modulation groups.
48 hours following EOC testing, subject will return for a second progressive maximal cycling test performed at FCC or EOC based on group assignment.
Subjects will then participate in a 6 week high intensity training (HIIT) indoor cycling program at their prescribed cadence (FCC or EOC), using cadence meters. Training will consist of three non-consecutive days each week for 60 min, and alternate between two HIIT workouts. Resistance will be increased to meet the HIIT requirement, while cadence will remain at FCC or EOC. Subjects will be asked to warm-up at a light (3/10) workload for 10 minutes, followed by HIIT consisting of 4 minutes at an intensity of 8/10 on the modified Borg, and 90 seconds recovery (2/10). This will be repeated 8 times, followed by 10 minutes of cool down. The alternating HIIT workout will include a 10 minute warm up, followed by 12 intervals lasting 2 minutes at an RPE of 9/10 and 3 minutes of recovery. The session will conclude with a 10 minute cool down.
Within one week of completing their training program, subjects will return for their fourth and final study visit, at which time a VO2max test and kinematic data collection will be repeated at FCC or EOC.
- Conditions
- Healthy
- Being tested
- Cycling Cadence Modulation
- Keywords
- bicycle, cadence, cyclist, modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling Cadence ModulationBehavioural
6-week high intensity training (HIIT) indoor cycling program, described later, at their prescribed cadence (FCC or EOC), using cadence meters.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cycling Cadence Modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exhaustion T(max)
time to reach exhaustion
Measured: Baseline
Ventilatory threshold (VT)
Measured: Baseline
Maximal cardiac output
Measured: Baseline
Maximal stroke volume
Measured: Baseline
decreased trunk lean
decrease in degree of lean in truck
Measured: Baseline
decreased ankle dorsiflexion
decrease in amount of ankle dorsiflexion
Measured: Baseline
decreased knee splay
decreased degree of knee splay
Measured: Baseline
Secondary outcomes (8)
Improved VO2 max
Increased maximum O2 volume
Measured: 6 weeks
Increased O2 consumption at VT
Improved oxygen consumption at ventilatory threshold
Measured: 6 weeks
Time to VT
Improved time to reach ventilatory threshold
Measured: 6 weeks
Time to T(max)
Improved time to reach exhaustion
Measured: 6 weeks
decreased trunk lean
decrease in degree of lean in truck
Measured: 6 weeks
decreased ankle dorsiflexion
decrease in amount of ankle dorsiflexion
Measured: 6 weeks
decreased knee splay
decreased degree of knee splay
Measured: 6 weeks
change in overall soreness and fatigue
decrease in reported soreness and fatigue as measured and reported via Metrifit software
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start26 Jun 2017
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Watson, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482726
- Sponsor's protocol ID
- 2017-0131
- Other IDs
- A536110, SMPH\ORTHOPEDIC&REHAB\ORTHO
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2017
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadence Modulation to Improve Well-Being, Kinematics and Aerobic Performance in Cyclists
- ClinicalTrials.gov ID
- NCT03482726
- Acronym / sponsor ID
- 2017-0131
- Conditions
- Healthy
- Keywords
- bicycle, cadence, cyclist, modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the first session, each individual will be asked to fill out a questionnaire to regarding cycling experience, prior bike fits (with data sheets when available), and injury history. Maximal aerobic capacity (VO2max) will be determined. During the test, subjects will be asked rate exertion. Before testing, the system will be calibrated with known oxygen and carbon dioxide concentrations. During the test, subjects will be asked to breathe normally through a low dead space bidirectional turbine. Inspired and expired gases will be analyzed for concentrations of O2 and CO2, to determine alveolar gas exchange. Total ventilation (VE), respiratory rate, oxygen consumption (VO2), carbon dioxide (VCO2) will be measured, and respiratory exchange ratio (RER; VCO2/VO2) will be calculated continuously during the test and expressed as a 30-second rolling average.
Participants will return 48 hours later, at which time EOC will be determined after a moderate intensity prolonged cycling exercise (PCE) at seven different cadences. Cadences from 50rpm to 110rpm will be randomly generated and introduced every 3 minutes, followed by a 3 minute cool down at FCC at 40% PP (Figure Subjects will then be pair matched by gender and randomized into control (FCC) or EOC modulation groups.
48 hours following EOC testing, subject will return for a second progressive maximal cycling test performed at FCC or EOC based on group assignment.
Subjects will then participate in a 6 week high intensity training (HIIT) indoor cycling program at their prescribed cadence (FCC or EOC), using cadence meters. Training will consist of three non-consecutive days each week for 60 min, and alternate between two HIIT workouts. Resistance will be increased to meet the HIIT requirement, while cadence will remain at FCC or EOC. Subjects will be asked to warm-up at a light (3/10) workload for 10 minutes, followed by HIIT consisting of 4 minutes at an intensity of 8/10 on the modified Borg, and 90 seconds recovery (2/10). This will be repeated 8 times, followed by 10 minutes of cool down. The alternating HIIT workout will include a 10 minute warm up, followed by 12 intervals lasting 2 minutes at an RPE of 9/10 and 3 minutes of recovery. The session will conclude with a 10 minute cool down.
Within one week of completing their training program, subjects will return for their fourth and final study visit, at which time a VO2max test and kinematic data collection will be repeated at FCC or EOC.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cycling Cadence Modulation | Other | Behavioral: Cycling Cadence Modulation3 initial visits to collect baseline information; 6-week HIIT indoor cycling program at the individual prescribed cadence; final study visit for post-intervention measures. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling Cadence Modulation6-week high intensity training (HIIT) indoor cycling program, described later, at their prescribed cadence (FCC or EOC), using cadence meters. | Behavioural | Cycling Cadence Modulation |
Primary outcome
Time to exhaustion T(max)
Time frame: Baseline
time to reach exhaustion
Ventilatory threshold (VT)
Time frame: Baseline
Maximal cardiac output
Time frame: Baseline
Maximal stroke volume
Time frame: Baseline
decreased trunk lean
Time frame: Baseline
decrease in degree of lean in truck
decreased ankle dorsiflexion
Time frame: Baseline
decrease in amount of ankle dorsiflexion
decreased knee splay
Time frame: Baseline
decreased degree of knee splay
8 secondary outcomes
Improved VO2 max
Time frame: 6 weeks
Increased O2 consumption at VT
Time frame: 6 weeks
Time to VT
Time frame: 6 weeks
Time to T(max)
Time frame: 6 weeks
decreased trunk lean
Time frame: 6 weeks
decreased ankle dorsiflexion
Time frame: 6 weeks
decreased knee splay
Time frame: 6 weeks
change in overall soreness and fatigue
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Watson, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling Cadence Modulation in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to exhaustion T(max) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.