Endothelial FunctionVascuFitNCT05235958
VascuFit: Exercise and Vascular Aging
A study testing non-linear periodized exercise (NLPE) and Exercise counselling in people with Endothelial Function and Aerobic Exercise, run by Karsten Königstein at 1 site in Switzerland.
Trial summary
Exercise is a cornerstone of health care helping to improve and maintain a good organ functionality, including vascular function, in health and disease. About twenty years ago, the introduction of high-intensity training has been a milestone in the evolution of exercise therapy by demonstrating the trainability of… Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function, Aerobic Exercise, Middle-aged Adults Sedentary, Elevated CV-risk)
- What is being tested?
- non-linear periodized exercise (NLPE) and Exercise counselling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 May 2022to 28 Feb 2023
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent, documented by signature
- sedentary lifestyle, as not performing exercise on a regular basis and reaching less than the recommended 7.5 MET hours of at least moderate intensity activity per week
- being mentally and physically able to attend and keep up training during the whole intervention period.
Who cannot join
- current or chronic condition limiting exhaustive exercise (e.g. heart failure, infection, pulmonary disease)
- any condition with elevated risk of a serious adverse event during exhaustive exercise (e.g. cardiomyopathy, acute myocardial infarction, stroke, uncontrolled hypertensive resting blood pressure ≥160/100mmHg)
- chronic condition with severe affection of the vascular system (e.g. severe atherosclerosis, severe chronic kidney disease, autoimmune vasculitis, insulin dependent diabetes mellitus)
- inability to follow advice during measurements and training sessions (e.g. language barriers, psychological disorders, dementia)
- previous enrollment into the current study or participation in another study in the last four weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Effects of Non-linear Periodized Exercise Training in Sedentary Adults With Elevated Cardiovascular Risk - The VascuFit Project
Exercise is a cornerstone of health care helping to improve and maintain a good organ functionality, including vascular function, in health and disease. About twenty years ago, the introduction of high-intensity training has been a milestone in the evolution of exercise therapy by demonstrating the trainability of individuals independent of age and state of disease. Today, its practical implementation still faces barriers, such as lower physical and mental tolerance of exercise, long-term adherence and lack of individualization of training for optimal adaptations.
The proposed project is the logical next step to introduce non-linear periodized exercise training (NLPE), a method widely established in elite athletes, in exercise training of sedentary individuals. NLPE alternatingly involves person-centred periodization of training cycles and regeneration with high-intensity stimuli. It induces a broader range of physiological adaptations than moderate-intensity training while keeping a high compliance and without increasing the risk of overreaching. A study of patients with chronic-obstructive-pulmonary-disease and a study with resistance training of older adults indicated promising pulmonary and muscular effects. However, the effectiveness of NLPE to maintain and improve vascular function has not yet been assessed, although this may carry a huge clinical and socioeconomic potential by contributing to the reduction of cardiovascular morbidity and mortality.
Read more
VascuFit applies an 8-week training intervention to assess the effects of NLPE on the function of the vascular endothelium, measured by the non-invasive gold-standard method brachial arterial flow-mediated dilation (baFMD), in a sample of sedentary aging adults with cardiovascular risk factors. In addition, it will be the first study to measure training effects on a cluster of micro-ribonucleic acids (miRNAs) regulating key molecular pathways of endothelial (dys-)function. Thus, VascuFit aims to explore the potential of clinical and molecular biomarkers for the monitoring of individual vascular adaptability to a specific type of exercise. As a first step, this pilot-project is supposed to deliver proof-of-concept. Furthermore, it will generate important hypotheses to be addressed by exercise physiologists, medical professionals and biologists concerned with the optimization of individual training adaptations as well as utility and implementation of targeted training approaches in the health care of aging adults.
VascuFit aims to demonstrate the potential of NLPE as a training regimen to improve vascular function in sedentary individuals with elevated cardiovascular risk. This project may be the initial spark to raise exercise training to the next level, which is clearly necessary to sustainably strengthen the vascular capacities of "young" aging individuals.
Read the detailed description
A detailed description of the study can be found at:
DOI: 10.1186/s12872-022-02905-1
- Being tested
- non-linear periodized exercise (NLPE), Exercise counselling
- Keywords
- endothelium, flow-mediated vasodilation, sedentary, cardiovascular risk, aerobic exercise, vascular ageing
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-linear periodized exercise (NLPE)Other
Aerobic training derived from professional sports, that is characterized by variable periodization of training frequency, volume and intensity according to individual factors, such as physical and mental readiness, training progress and performance level
Exercise counsellingOther
Standard recommendations for exercise and physical activity, that are individualized according to a medical health and fitness profile
| Study group | Role | What they receive |
|---|---|---|
| Training intervention | Experimental | 8 weeks of non-linear periodized aerobic exercise; 3 sessions per week; 1 hour per session; standardized warm-up; individual training intensity according to cardiorespiratory fitness level Receives: Other: non-linear periodized exercise (NLPE) |
| Control Intervention | Sham comparator | Recommendation to continue with current lifestyle (especially physical activity habits) during the following 8 weeks. At the final assessment after 8 weeks, individualized exercise recommendations according to established standard procedures in exercise medicine and offer to attend the standard medical follow-up in our outpatient clinics subsequent to study termination Receives: Other: Exercise counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial-arterial flow-mediated vasodilation (baFMD)
Non-invasive ultrasound-based measurement of endothelial responsiveness of the brachial artery to an hyperemic stimulus. Changes of baFMD after the 8-week study period in comparison to the pre-intervention baseline values will be assessed.
Measured: 8 weeks
Secondary outcomes (1)
endomiR
Quantification of several micro-RNAs involved in key-regulatory pathways of the endothelial function of the macrovascular circulation. Changes of this micro-RNA cluster (endomiR) after the 8-week study period in comparison to the pre-intervention baseline values will be assessed.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start2 May 2022
- Primary completion21 Dec 2022
- Study completion28 Feb 2023
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 Endothelial FunctionStudies 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
- Model description
- Randomized controlled training intervention (8-weeks) with assessment of changes in clinical and molecular vascular biomarkers compared to their baseline value before the intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karsten Königstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, QIAGEN Gaithersburg, Inc
- Responsible party
- Sponsor-investigator, Karsten Königstein, University of Basel
- Investigators
- Karsten Königstein, Dr. med., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235958
- Sponsor's protocol ID
- VF_CTgov
- Acronym
- VascuFit
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the results, anonymized data and analytic codes may be shared upon request by the principal investigator (Dr. K. Königstein)
Publications
Konigstein K, Meier J, Angst T, Maurer DJ, Kropfl JM, Carrard J, Infanger D, Baumann S, Bischofsberger I, Harder M, Jaggi Y, Wettach S, Hanssen H, Schmidt-Trucksass A. VascuFit: vascular effects of non-linear periodized exercise training in sedentary adults with elevated cardiovascular risk - protocol for a randomized controlled trial. BMC Cardiovasc Disord. 2022 Oct 27;22(1):449. doi: 10.1186/s12872-022-02905-1.
PubMed 36303113
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Effects of Non-linear Periodized Exercise Training in Sedentary Adults With Elevated Cardiovascular Risk - The VascuFit Project
- ClinicalTrials.gov ID
- NCT05235958
- Acronym / sponsor ID
- VascuFit / VF_CTgov
- Keywords
- endothelium, flow-mediated vasodilation, sedentary, cardiovascular risk, aerobic exercise, vascular ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Karsten KönigsteinUniversity, hospital or other
- Collaborators
- University of Basel, QIAGEN Gaithersburg, Inc
- Study start
- 2 May 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 11 Feb 2022 (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.
Exercise is a cornerstone of health care helping to improve and maintain a good organ functionality, including vascular function, in health and disease. About twenty years ago, the introduction of high-intensity training has been a milestone in the evolution of exercise therapy by demonstrating the trainability of individuals independent of age and state of disease. Today, its practical implementation still faces barriers, such as lower physical and mental tolerance of exercise, long-term adherence and lack of individualization of training for optimal adaptations.
The proposed project is the logical next step to introduce non-linear periodized exercise training (NLPE), a method widely established in elite athletes, in exercise training of sedentary individuals. NLPE alternatingly involves person-centred periodization of training cycles and regeneration with high-intensity stimuli. It induces a broader range of physiological adaptations than moderate-intensity training while keeping a high compliance and without increasing the risk of overreaching. A study of patients with chronic-obstructive-pulmonary-disease and a study with resistance training of older adults indicated promising pulmonary and muscular effects. However, the effectiveness of NLPE to maintain and improve vascular function has not yet been assessed, although this may carry a huge clinical and socioeconomic potential by contributing to the reduction of cardiovascular morbidity and mortality.
VascuFit applies an 8-week training intervention to assess the effects of NLPE on the function of the vascular endothelium, measured by the non-invasive gold-standard method brachial arterial flow-mediated dilation (baFMD), in a sample of sedentary aging adults with cardiovascular risk factors. In addition, it will be the first study to measure training effects on a cluster of micro-ribonucleic acids (miRNAs) regulating key molecular pathways of endothelial (dys-)function. Thus, VascuFit aims to explore the potential of clinical and molecular biomarkers for the monitoring of individual vascular adaptability to a specific type of exercise. As a first step, this pilot-project is supposed to deliver proof-of-concept. Furthermore, it will generate important hypotheses to be addressed by exercise physiologists, medical professionals and biologists concerned with the optimization of individual training adaptations as well as utility and implementation of targeted training approaches in the health care of aging adults.
VascuFit aims to demonstrate the potential of NLPE as a training regimen to improve vascular function in sedentary individuals with elevated cardiovascular risk. This project may be the initial spark to raise exercise training to the next level, which is clearly necessary to sustainably strengthen the vascular capacities of "young" aging individuals.
Detailed description
A detailed description of the study can be found at:
DOI: 10.1186/s12872-022-02905-1
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled training intervention (8-weeks) with assessment of changes in clinical and molecular vascular biomarkers compared to their baseline value before the intervention
| Arm | Type | Receives |
|---|---|---|
| Training intervention | Experimental | Other: non-linear periodized exercise (NLPE)8 weeks of non-linear periodized aerobic exercise; 3 sessions per week; 1 hour per session; standardized warm-up; individual training intensity according to cardiorespiratory fitness level |
| Control Intervention | Sham comparator | Other: Exercise counsellingRecommendation to continue with current lifestyle (especially physical activity habits) during the following 8 weeks. At the final assessment after 8 weeks, individualized exercise recommendations according to established standard procedures in exercise medicine and offer to attend the standard medical follow-up in our outpatient clinics subsequent to study termination |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed consent, documented by signature
- sedentary lifestyle, as not performing exercise on a regular basis and reaching less than the recommended 7.5 MET hours of at least moderate intensity activity per week
- being mentally and physically able to attend and keep up training during the whole intervention period.
Key exclusion criteria (5 listed)
- current or chronic condition limiting exhaustive exercise (e.g. heart failure, infection, pulmonary disease)
- any condition with elevated risk of a serious adverse event during exhaustive exercise (e.g. cardiomyopathy, acute myocardial infarction, stroke, uncontrolled hypertensive resting blood pressure ≥160/100mmHg)
- chronic condition with severe affection of the vascular system (e.g. severe atherosclerosis, severe chronic kidney disease, autoimmune vasculitis, insulin dependent diabetes mellitus)
- inability to follow advice during measurements and training sessions (e.g. language barriers, psychological disorders, dementia)
- previous enrollment into the current study or participation in another study in the last four weeks.
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 |
|---|---|---|
| non-linear periodized exercise (NLPE)Aerobic training derived from professional sports, that is characterized by variable periodization of training frequency, volume and intensity according to individual factors, such as physical and mental readiness, training progress and performance level | Other | Training intervention |
| Exercise counsellingStandard recommendations for exercise and physical activity, that are individualized according to a medical health and fitness profile | Other | Control Intervention |
Primary outcome
Brachial-arterial flow-mediated vasodilation (baFMD)
Time frame: 8 weeks
Non-invasive ultrasound-based measurement of endothelial responsiveness of the brachial artery to an hyperemic stimulus. Changes of baFMD after the 8-week study period in comparison to the pre-intervention baseline values will be assessed.
1 secondary outcome
endomiR
Time frame: 8 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 4 Dec 2023.
- Derived from this study: PubMed 36303113Konigstein K, Meier J, Angst T, Maurer DJ, Kropfl JM, Carrard J, Infanger D, Baumann S, Bischofsberger I, Harder M, Jaggi Y, Wettach S, Hanssen H, Schmidt-Trucksass A. VascuFit: vascular effects of non-linear periodized exercise training in sedentary adults with elevated cardiovascular risk - protocol for a randomized controlled trial. BMC Cardiovasc Disord. 2022 Oct 27;22(1):449. doi: 10.1186/s12872-022-02905-1.
- Individual participant dataSharing planned: Yes. After publication of the results, anonymized data and analytic codes may be shared upon request by the principal investigator (Dr. K. Königstein)
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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.
Karsten Königstein, Dr. med. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-linear periodized exercise (NLPE) and Exercise counselling in people with Endothelial Function and Aerobic Exercise, run by Karsten Königstein at 1 site in Switzerland.
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 5 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 4 Dec 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Brachial-arterial flow-mediated vasodilation (baFMD) (time frame: 8 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 NCT05235958, 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 4 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.