Cardiovascular DiseaseNCT02868710
Individual Variability to Aerobic Exercise Training
A study testing Exercise in people with Cardiovascular Disease, run by Western Colorado University at 1 site in United States.
Trial summary
The purpose of this study is to: 1) determine the cohort specific technical error to use in the categorization of response rate; 2) determine if an individualized intensity prescription is superior to a standard approach in regards to VO2max and cardiometabolic risk factor responsiveness; 3) Investigate the time… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to May 2018
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Considered low to moderate risk for cardiovascular disease based on the American College of Sports medicine guidelines
- Currently sedentary (participating in less than 30 minutes of moderate intensity physical activity on at least three days a week)
- Resided at an altitude of 2300 meters for at least the last 6 months
Who cannot join
- Any known sign, symptom, or diagnosed cardiovascular, pulmonary, metabolic, or similar disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Western State Colorado University
Gunnison, Colorado, 82131
About this study
Official title: The Incidence of Training Responsiveness to Cardiorespiratory Fitness and Cardiometabolic Measurements Following Individualized and Standardized Exercise Prescription
The purpose of this study is to: 1) determine the cohort specific technical error to use in the categorization of response rate; 2) determine if an individualized intensity prescription is superior to a standard approach in regards to VO2max and cardiometabolic risk factor responsiveness; 3) Investigate the time course changes throughout 12 weeks of CRF training between an individualized and standardized exercise prescription; and 4) determine if non-responders can become responders if the exercise intensity prescription is modified.
It is hypothesized that:
- The individualized method will elicit a greater responsiveness for all measurements when compared to the standardized method.
- There will be a greater amount of non-responders in the standardized group (based on changes in VO2max).
- When participants in the standardized group are considered non-responders and change their exercise prescription to the individualized group, they will become a responder (based on changes in VO2max)
Read the detailed description
It has generally been accepted there is individual variability to cardiorespiratory fitness (CRF) training. However, the underlying cause of the variability is not well understood. Traditionally, a standardized approach to exercise prescription has utilized relative percentages of maximal heart rate (HR), HR reserve (HRR), maximal oxygen consumption (VO2max), or VO2 reserve to establish exercise intensity. This 'one size fits all' model fails to take into consideration individual metabolic responses to exercise and may be related to the variability in training responses.
An individualized exercise prescription utilizing a threshold-based training model (i.e. ventilatory threshold) would help consider individual metabolic responses to exercise training. However, minimal research has been conducted to differentiate between the standardized and individualized methods. Therefore, a randomized control trial within a community-based wellness program will be implemented to investigate the following research question: does an individualized exercise prescription decrease the incidence of non-response to CRF and cardiometabolic measurements compared to the standardized approach? The criteria to determine the incidence of response will be set based on the biological variability and measurement error determined during baseline testing.
A secondary outcome of the study will be investigating the time course changes in response to 12 weeks of individualized and standardized exercise prescription. Currently, minimal research exists on the effects of differing exercise prescription and the time course changes with the reporting of individual data.
Many experimental trials are conducted in a very controlled and supervised environment and may lack real world application. This investigation would occur in a community-based wellness program to encourage a 'real-world' application. Results of this study would enhance the ability of exercise physiologists to prescribe exercise to the individual, rather than a 'one size fits all' model. This would be the first study to investigate individualized versus standardized exercise prescription with an isocaloric exercise volume.
Therefore, sedentary men and women (n = 40) will be randomized to one of two experimental groups - individualized or standardized. There will be a separate control group (n = 20) that is recruited from the community that has the same inclusion criteria as the experimental group. Exercise training will be performed 3 days a week with weekly energy expenditure progressively increasing from 5.6 to 15.4 kcal/kg/week for 12 weeks with one of two exercise intensity regimens: 1) a standardized method based on percentages of HRR, or 2) a threshold based method with the use of the first (VT1) and second ventilatory threshold (VT2). Participants will undergo testing (anthropometric measures, blood profile, and maximal exercise test) at baseline, 4 weeks, 8 weeks, and 12 weeks.
Following the 12 week intervention, participants will be categorized as a responder or non-responder based on overall changes in VO2max. For responders, they will be done with the intervention. However, non-responders will be asked to complete a second 12 week intervention in the other experimental group (i.e. a non-responder in the standardized group will now complete a 12 week intervention the individualized group. The exercise prescription and progression will be the same for the second 12 weeks.
- Conditions
- Cardiovascular Disease
- Being tested
- Exercise
- Keywords
- primary prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Continuous aerobic exercise prescribed according to two exercise intensity methods: individualized (i.e. ventilatory threshold) and standardized (i.e. heart rate reserve)
| Study group | Role | What they receive |
|---|---|---|
| Individualized method | Experimental | 3 days a week of exercise at the following intensity and energy expenditure:
Week 1: HR > VT1; 5.6 kcal/kg/wk Week 2: HR > VT1; 8.4 kcal/kg/wk Week 3: HR > VT1; 11.2 kcal/kg/wk Week 4: HR ≥ VT1 to <VT2; 11.2 kcal/kg/wk Week 5-6: HR ≥ VT1 to <VT2; 11.2 kcal/kg/wk Week 7: HR ≥ VT1 to <VT2; 12.6 kcal/kg/wk Week 8: HR ≥ VT1 to <VT2; 14 kcal/kg/wk Week 9-10: HR ≥ VT2; 14 kcal/kg/wk Week 11-12: HR ≥ VT2; 15.4 kcal/kg/wk Receives: Other: Exercise |
| Standardized method | Experimental | 3 days a week of exercise at the following intensity and energy expenditure:
Week 1: 40-45% HRR; 5.6 kcal/kg/wk Week 2: 40-45% HRR; 8.4 kcal/kg/wk Week 3: 40-45% HRR; 11.2 kcal/kg/wk Week 4: 50-55% HRR; 11.2 kcal/kg/wk Week 5-6: 55-60% HRR; 11.2 kcal/kg/wk Week 7: 55-60% HRR; 12.6 kcal/kg/wk Week 8: 55-60% HRR; 14 kcal/kg/wk Week 9-10: 60-65% HRR; 14 kcal/kg/wk Week 11-12: 60-65% HRR; 15.4 kcal/kg/wk Receives: Other: Exercise |
| Control | No intervention | non-exercise control group Testing at baseline and post-program (12 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Uptake (VO2max)
Measured: 12 weeks
Secondary outcomes (10)
Total cholesterol
Measured: 12 weeks
Low-density lipoprotein
Measured: 12 weeks
High-density lipoprotein
Measured: 12 weeks
Triglycerides
Measured: 12 weeks
Fasting blood glucose
Measured: 12 weeks
Waist circumference
Measured: 12 weeks
Height
Measured: 12 weeks
Weight
Measured: 12 weeks
Resting heart rate
Measured: 12 weeks
Resting blood pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Colorado University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lance Dalleck, Western Colorado University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868710
- Sponsor's protocol ID
- WeternStateCU
- Status last verified
- Oct 2018
- First submitted
- 9 Aug 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Weatherwax RM, Harris NK, Kilding AE, Dalleck LC. The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial. Trials. 2016 Dec 19;17(1):601. doi: 10.1186/s13063-016-1735-0.
PubMed 27993169
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Training Responsiveness to Cardiorespiratory Fitness and Cardiometabolic Measurements Following Individualized and Standardized Exercise Prescription
- ClinicalTrials.gov ID
- NCT02868710
- Acronym / sponsor ID
- WeternStateCU
- Conditions
- Cardiovascular Disease
- Keywords
- primary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Western Colorado UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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.
The purpose of this study is to: 1) determine the cohort specific technical error to use in the categorization of response rate; 2) determine if an individualized intensity prescription is superior to a standard approach in regards to VO2max and cardiometabolic risk factor responsiveness; 3) Investigate the time course changes throughout 12 weeks of CRF training between an individualized and standardized exercise prescription; and 4) determine if non-responders can become responders if the exercise intensity prescription is modified.
It is hypothesized that:
- The individualized method will elicit a greater responsiveness for all measurements when compared to the standardized method.
- There will be a greater amount of non-responders in the standardized group (based on changes in VO2max).
- When participants in the standardized group are considered non-responders and change their exercise prescription to the individualized group, they will become a responder (based on changes in VO2max)
Detailed description
It has generally been accepted there is individual variability to cardiorespiratory fitness (CRF) training. However, the underlying cause of the variability is not well understood. Traditionally, a standardized approach to exercise prescription has utilized relative percentages of maximal heart rate (HR), HR reserve (HRR), maximal oxygen consumption (VO2max), or VO2 reserve to establish exercise intensity. This 'one size fits all' model fails to take into consideration individual metabolic responses to exercise and may be related to the variability in training responses.
An individualized exercise prescription utilizing a threshold-based training model (i.e. ventilatory threshold) would help consider individual metabolic responses to exercise training. However, minimal research has been conducted to differentiate between the standardized and individualized methods. Therefore, a randomized control trial within a community-based wellness program will be implemented to investigate the following research question: does an individualized exercise prescription decrease the incidence of non-response to CRF and cardiometabolic measurements compared to the standardized approach? The criteria to determine the incidence of response will be set based on the biological variability and measurement error determined during baseline testing.
A secondary outcome of the study will be investigating the time course changes in response to 12 weeks of individualized and standardized exercise prescription. Currently, minimal research exists on the effects of differing exercise prescription and the time course changes with the reporting of individual data.
Many experimental trials are conducted in a very controlled and supervised environment and may lack real world application. This investigation would occur in a community-based wellness program to encourage a 'real-world' application. Results of this study would enhance the ability of exercise physiologists to prescribe exercise to the individual, rather than a 'one size fits all' model. This would be the first study to investigate individualized versus standardized exercise prescription with an isocaloric exercise volume.
Therefore, sedentary men and women (n = 40) will be randomized to one of two experimental groups - individualized or standardized. There will be a separate control group (n = 20) that is recruited from the community that has the same inclusion criteria as the experimental group. Exercise training will be performed 3 days a week with weekly energy expenditure progressively increasing from 5.6 to 15.4 kcal/kg/week for 12 weeks with one of two exercise intensity regimens: 1) a standardized method based on percentages of HRR, or 2) a threshold based method with the use of the first (VT1) and second ventilatory threshold (VT2). Participants will undergo testing (anthropometric measures, blood profile, and maximal exercise test) at baseline, 4 weeks, 8 weeks, and 12 weeks.
Following the 12 week intervention, participants will be categorized as a responder or non-responder based on overall changes in VO2max. For responders, they will be done with the intervention. However, non-responders will be asked to complete a second 12 week intervention in the other experimental group (i.e. a non-responder in the standardized group will now complete a 12 week intervention the individualized group. The exercise prescription and progression will be the same for the second 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized method | Experimental | Other: Exercise3 days a week of exercise at the following intensity and energy expenditure: Week 1: HR > VT1; 5.6 kcal/kg/wk Week 2: HR > VT1; 8.4 kcal/kg/wk Week 3: HR > VT1; 11.2 kcal/kg/wk Week 4: HR ≥ VT1 to <VT2; 11.2 kcal/kg/wk Week 5-6: HR ≥ VT1 to <VT2; 11.2 kcal/kg/wk Week 7: HR ≥ VT1 to <VT2; 12.6 kcal/kg/wk Week 8: HR ≥ VT1 to <VT2; 14 kcal/kg/wk Week 9-10: HR ≥ VT2; 14 kcal/kg/wk Week 11-12: HR ≥ VT2; 15.4 kcal/kg/wk |
| Standardized method | Experimental | Other: Exercise3 days a week of exercise at the following intensity and energy expenditure: Week 1: 40-45% HRR; 5.6 kcal/kg/wk Week 2: 40-45% HRR; 8.4 kcal/kg/wk Week 3: 40-45% HRR; 11.2 kcal/kg/wk Week 4: 50-55% HRR; 11.2 kcal/kg/wk Week 5-6: 55-60% HRR; 11.2 kcal/kg/wk Week 7: 55-60% HRR; 12.6 kcal/kg/wk Week 8: 55-60% HRR; 14 kcal/kg/wk Week 9-10: 60-65% HRR; 14 kcal/kg/wk Week 11-12: 60-65% HRR; 15.4 kcal/kg/wk |
| Control | No intervention | –non-exercise control group Testing at baseline and post-program (12 weeks) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Considered low to moderate risk for cardiovascular disease based on the American College of Sports medicine guidelines
- Currently sedentary (participating in less than 30 minutes of moderate intensity physical activity on at least three days a week)
- Resided at an altitude of 2300 meters for at least the last 6 months
Key exclusion criteria (1 listed)
- Any known sign, symptom, or diagnosed cardiovascular, pulmonary, metabolic, or similar disease
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 |
|---|---|---|
| ExerciseContinuous aerobic exercise prescribed according to two exercise intensity methods: individualized (i.e. ventilatory threshold) and standardized (i.e. heart rate reserve) | Other | Individualized method, Standardized method |
Primary outcome
Maximal Oxygen Uptake (VO2max)
Time frame: 12 weeks
10 secondary outcomes
Total cholesterol
Time frame: 12 weeks
Low-density lipoprotein
Time frame: 12 weeks
High-density lipoprotein
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
Fasting blood glucose
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Height
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Resting heart rate
Time frame: 12 weeks
Resting blood pressure
Time frame: 12 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 2 Oct 2018.
- Derived from this study: PubMed 27993169Weatherwax RM, Harris NK, Kilding AE, Dalleck LC. The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial. Trials. 2016 Dec 19;17(1):601. doi: 10.1186/s13063-016-1735-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cardiovascular Disease, run by Western Colorado University 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 1 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 2 Oct 2018. 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?
Maximal Oxygen Uptake (VO2max) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868710, which also lists 1 linked publication.
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 2 Oct 2018.