AgeingPUMPING ARTERYNCT06616428
Acute Exercise Effects on Arterial Stiffness and Cardiovagal Modulation in Adults
A study testing Bike group fitness class, Pump Power and Global Training in people with Ageing and Aerobic Exercise, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
Background and Gap: The physiological importance of large artery distensibility in cardiovascular function is well-established. Stiffening of central arteries leads to elevated systolic blood pressure (SBP), increased left ventricular afterload, and altered coronary artery perfusion. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ageing, Aerobic Exercise, Resistance Exercise
- What is being tested?
- Bike group fitness class, Pump Power and Global Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePortugal
- Study dates
- 6 Jan 2020to 11 Mar 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physically active, as assessed by the International Physical Activity Questionnaire (IPAQ)
- Experience in both aerobic and resistance exercise (∼3-4 times/week, for more than 3 months).
- Healthy or perceived to be healthy based on the sport's medical examination or the preparticipation screening process, Physical Activity Readiness Questionnaire for Everyone (PARQ+).
Who cannot join
- Any form of cardiovascular disease
- More than one cardiovascular disease risk factor
- Resting hypertension (SBP \>140 mmHg, DBP \> 90 mmHg)
- Any prescription medication use that may influence vascular and autonomic response to exercise
- Being an athlete
- Currently smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Commercial Group Exercise Classes on Arterial Stiffness and Cardiovagal Modulation in Healthy Young and Middle-aged Adults: an Ecological Valid Model
Background and Gap:
The physiological importance of large artery distensibility in cardiovascular function is well-established. Stiffening of central arteries leads to elevated systolic blood pressure (SBP), increased left ventricular afterload, and altered coronary artery perfusion. These changes can elevate cardiovascular disease risk and all-cause mortality. Cardiac autonomic function, including heart rate recovery (HRR) and heart rate variability (HRV), is closely linked to blood pressure regulation. Reductions in HRR and HRV are predictive of cardiovascular mortality. The dynamic regulation of arterial stiffness and autonomic function post-exercise is crucial for both health and performance outcomes. Exercise, particularly aerobic, has been shown to reduce arterial stiffness, but evidence across different exercise modalities is limited, especially for group fitness classes. These classes are a common method for achieving cardiovascular fitness, but their acute effects on arterial stiffness and autonomic function remain understudied.
Read more
Study Type: Parallel Group Crossover Randomised Trial Primary Purpose: To assess and compare the acute effects of three commercially available group exercise classes on arterial stiffness and cardiovagal modulation in healthy young and middle-aged adults.
Study Population: Healthy adults aged 18-60 years.
Main Question:
How does age influence post-exercise recovery patterns in arterial stiffness and cardiovagal modulation following different group fitness classes?
Comparison Group: Researchers compared arterial stiffness and autonomic function responses across three group fitness classes in young and older adults.
Participant Tasks:
- Attend a 60-minute group exercise class.
- Undergo measurements of arterial stiffness and autonomic function before and after 3 group fitness classes.
Read the detailed description
All participants were randomly assigned to 1 of 4 experimental conditions using a randomized block scheme (https://www.randomizer.org/). Participants completed 4 separate intervention sessions, each consisting of an initial rest, a group fitness class of either indoor cycling, resistance training, combined exercise training, or no exercise (CON), followed by a recovery period. A minimum of 72 hours between sessions was ensured. Body composition and cardiorespiratory fitness for each participant were evaluated before and after the CON session, respectively.
Each session began with 20 minutes of supine rest on a cushioned examination table, with resting energy expenditure (REE) measured by indirect calorimetry (K5, Cosmed, Rome, Italy) and heart rate (HR) and blood pressure (BP) recorded continuously using digital plethysmography (Finapres, NOVA, Finapres Medical Systems, Amsterdam, The Netherlands). This was followed by: 1) Regional assessments of PWV and pulse wave analysis of the carotid, brachial, femoral, and distal arteries on the right side of the body using applanation tonometry (Complior 2.0, Alam Medical; Saint Quentin Fallavier, France); and 2) Assessment of heart rate variability (HRV) and baroreflex sensitivity (BRS) indices using the Finapres NOVA 5 ECG lead module. Following these assessments, participants engaged in a 45-minute group fitness class, while activity energy expenditure (AEE) was continuously measured by indirect calorimetry (K5, Cosmed, Rome, Italy). In the CON session, participants remained comfortably seated for 45 minutes, maintaining a good posture. After each group fitness class, participants immediately returned to the examination table and recovered in the supine position for 30 minutes, during which local and regional stiffness, HRV, and baroreflex sensitivity (BRS) were re-evaluated at 10-, 20-, and 30-minute intervals during recovery and compared to those at rest. Participants were blinded to the order of the experimental interventions until arrival at the laboratory. All sessions were conducted in the morning to minimize potential diurnal variation. Participants were also instructed not to ingest any food or drink (except water) 4 hours before the sessions and to avoid alcohol, caffeine, and exercise for at least 24 hours preceding each session.
Based on a medium effect size of 0.154 derived from published changes in aortic PWV within-between modes of exercise (23), an a priori power analysis suggested that 22 participants were required (11 per group) to detect significant differences within-between groups, conditions, and time points (1-β = 80%, α = 0.05).
- Conditions
- Ageing, Aerobic Exercise, Resistance Exercise, Combined Exercise
- Being tested
- Bike group fitness class, Pump Power, Global Training
- Keywords
- Arterial stiffness, Cardiac autonomic function, Group exercise, Age differences, Ecological validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bike group fitness classOther
Comprised a rhythmic indoor cycling session, characterized by fluctuations in intensity corresponding to changes in position, music rhythm, cadence, and revolutions per minute. Participants were instructed to strictly follow verbal cues from the instructor, adjusting cycling cadence and resistance as directed, for 45 minutes.
Pump PowerOther
Entails a comprehensive total-body weight-training program with a focus on improving strength, muscular endurance, and overall fitness of large muscle groups. The class, choreographed to music, involved participants performing a combination of barbell, body-weight exercises, and free-weight plates, during 45 minutes. Participants selected weights based on the target muscle group for the specific song or track and their individual fitness goals.
Global TrainingOther
Incorporated both aerobic and resistance components, combining athletic movements like running, lunging, and jumping with strength exercises such as barbells, body-weight exercises, and free-weight plates for the large muscle groups, during 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Not described Receives: Other: Bike group fitness class |
| Resistance Exercise | Experimental | Not described Receives: Other: Pump Power |
| Combined Exercise | Experimental | Not described Receives: Other: Global Training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Blood Pressure
Resting brachial blood pressures (systolic and diastolic) were measured in the supine position using an automated oscillometric cuff (HEM-907 XL; Omron Corporation, Japan). Two measurements were taken, and the average was recorded for analysis. Pulse pressure was calculated as the difference between systolic and diastolic blood pressure. Central blood pressure was assessed by applanation tonometry (Complior 2.0, Alam Medical; Saint Quentin Fallavier, France) from right carotid traces obtained during carotid-femoral pulse wave velocity assessment. The waveforms were averaged, and mean values were taken from a 15-second acquisition window. Carotid waveforms were calibrated using mean arterial pressure measured just before acquisition.
Measured: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
Changes in Heart Rate Variability
R-R intervals were sampled at 300 Hz using a 5-ECG lead module (Finapres Nova, Finapres Medical Systems). Heart rate variability analyses were conducted offline with FisioSinal software in Matlab. After detecting R-R peaks and removing artifacts, 2-minute time series were created using cubic spline interpolation to estimate time-domain and spectral power indices. Ectopic heartbeats (mean = 1, SD = 6 bpm) were excluded. Time-domain indices included SDNN (overall variability) and RMSSD (cardiovagal modulation). Daubechy-12 wavelet analysis estimated low-frequency (vagal/sympathetic) and high-frequency (cardiovagal) bands.
Measured: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
Changes in Cardiovagal Baroreflex Sensitivity
Baroreceptor Sensitivity was estimated using the spontaneous sequence method in FisioSinal, focusing on SBP (more than 1 mmHg) and RR interval (more than 4 ms) ramps. SBP was recorded using finger plethysmography (Finapres® NOVA).
Measured: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
Changes in Regional Arterial Stiffness
Pressure waveforms from the carotid, femoral, radial, and distal arteries were captured simultaneously using applanation tonometry (Complior 2.0, Alam Medical; Saint Quentin Fallavier, France). The distance between pulse sites was measured and entered into the software, with carotid-femoral distance corrected by a 0.8 factor. Sensors were positioned for the carotid and radial arteries, while femoral and distal posterior tibial arteries were held manually. After obtaining 10 carotid pulse waveforms, simultaneous recording of carotid, femoral, radial, and distal posterior tibial pressure curves occurred. Transit time between waveforms was calculated using the foot-to-foot algorithm. Pulse wave velocity from carotid to femoral, carotid to radial, and carotid to distal posterior tibial arteries were used as indices of central and peripheral arterial stiffness.
Measured: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
Secondary outcomes (1)
Energy Expenditure
For the resting energy expenditure (REE) assessment, participants arrived 60 minutes before each session after a 2-3 hour fast. After 10 minutes of seated rest in a dimly lit room, REE was measured for 15 minutes using indirect calorimetry (K5, Cosmed, Rome, Italy). VO2, CO2, respiratory exchange ratio, and ventilation were continuously collected and averaged over 1-minute intervals. The first 5 minutes of data were discarded, and the mean of a 5-minute steady-state interval, where RER ranged from 0.7 to 1.0, was used to calculate REE. The mean VO2 and CO2 during this steady state were applied to the Weir equation, and the lowest REE period was used.
VO2 was also measured throughout the session for total energy expenditure (TEE) analysis. Activity energy expenditure (AEE) was calculated as TEE minus REE and 0.1*TEE. REE was also used to calculate intensities in metabolic equivalents.
Measured: Before and throughout the group fitness classes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start6 Jan 2020
- Primary completion26 Nov 2021
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgeingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel group crossover randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Melo, PhD, Principal investigator, Egas Moniz School of Health & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616428
- Sponsor's protocol ID
- PUMPING ARTERIES
- Acronym
- PUMPING ARTERY
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained in this study may be provided to qualified researchers with academic interest in vascular responses to resistance training with blood flow restriction. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Maroco JL, Pinto M, Laranjo S, Santa-Clara H, Fernhall B, Melo X. Cardiovagal Modulation in Young and Older Male Adults Following Acute Aerobic Exercise. Int J Sports Med. 2022 Oct;43(11):931-940. doi: 10.1055/a-1843-7974. Epub 2022 May 4.
PubMed 35508200Cunha FA, Midgley AW, Goncalves T, Soares PP, Farinatti P. Parasympathetic reactivation after maximal CPET depends on exercise modality and resting vagal activity in healthy men. Springerplus. 2015 Feb 27;4:100. doi: 10.1186/s40064-015-0882-1. eCollection 2015.
PubMed 25793148Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.
PubMed 25333969Michael S, Graham KS, Davis GM Oam. Cardiac Autonomic Responses during Exercise and Post-exercise Recovery Using Heart Rate Variability and Systolic Time Intervals-A Review. Front Physiol. 2017 May 29;8:301. doi: 10.3389/fphys.2017.00301. eCollection 2017.
PubMed 28611675Melo X, Lopes A, Coelho R, Simao B, Oliveira I, Maroco JL, Laranjo S, Fernhall B, Santa-Clara H. Acute effects of commercial group exercise classes on arterial stiffness and cardiovagal modulation in healthy young and middle-aged adults: A crossover randomized trial. PLoS One. 2025 Mar 13;20(3):e0319130. doi: 10.1371/journal.pone.0319130. eCollection 2025.
PubMed 40080484
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Commercial Group Exercise Classes on Arterial Stiffness and Cardiovagal Modulation in Healthy Young and Middle-aged Adults: an Ecological Valid Model
- ClinicalTrials.gov ID
- NCT06616428
- Acronym / sponsor ID
- PUMPING ARTERY / PUMPING ARTERIES
- Conditions
- Ageing, Aerobic Exercise, Resistance Exercise, Combined Exercise
- Keywords
- Arterial stiffness, Cardiac autonomic function, Group exercise, Age differences, Ecological validity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 27 Sep 2024 (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.
Background and Gap:
The physiological importance of large artery distensibility in cardiovascular function is well-established. Stiffening of central arteries leads to elevated systolic blood pressure (SBP), increased left ventricular afterload, and altered coronary artery perfusion. These changes can elevate cardiovascular disease risk and all-cause mortality. Cardiac autonomic function, including heart rate recovery (HRR) and heart rate variability (HRV), is closely linked to blood pressure regulation. Reductions in HRR and HRV are predictive of cardiovascular mortality. The dynamic regulation of arterial stiffness and autonomic function post-exercise is crucial for both health and performance outcomes. Exercise, particularly aerobic, has been shown to reduce arterial stiffness, but evidence across different exercise modalities is limited, especially for group fitness classes. These classes are a common method for achieving cardiovascular fitness, but their acute effects on arterial stiffness and autonomic function remain understudied.
Study Type: Parallel Group Crossover Randomised Trial Primary Purpose: To assess and compare the acute effects of three commercially available group exercise classes on arterial stiffness and cardiovagal modulation in healthy young and middle-aged adults.
Study Population: Healthy adults aged 18-60 years.
Main Question:
How does age influence post-exercise recovery patterns in arterial stiffness and cardiovagal modulation following different group fitness classes?
Comparison Group: Researchers compared arterial stiffness and autonomic function responses across three group fitness classes in young and older adults.
Participant Tasks:
- Attend a 60-minute group exercise class.
- Undergo measurements of arterial stiffness and autonomic function before and after 3 group fitness classes.
Detailed description
All participants were randomly assigned to 1 of 4 experimental conditions using a randomized block scheme (https://www.randomizer.org/). Participants completed 4 separate intervention sessions, each consisting of an initial rest, a group fitness class of either indoor cycling, resistance training, combined exercise training, or no exercise (CON), followed by a recovery period. A minimum of 72 hours between sessions was ensured. Body composition and cardiorespiratory fitness for each participant were evaluated before and after the CON session, respectively.
Each session began with 20 minutes of supine rest on a cushioned examination table, with resting energy expenditure (REE) measured by indirect calorimetry (K5, Cosmed, Rome, Italy) and heart rate (HR) and blood pressure (BP) recorded continuously using digital plethysmography (Finapres, NOVA, Finapres Medical Systems, Amsterdam, The Netherlands). This was followed by: 1) Regional assessments of PWV and pulse wave analysis of the carotid, brachial, femoral, and distal arteries on the right side of the body using applanation tonometry (Complior 2.0, Alam Medical; Saint Quentin Fallavier, France); and 2) Assessment of heart rate variability (HRV) and baroreflex sensitivity (BRS) indices using the Finapres NOVA 5 ECG lead module. Following these assessments, participants engaged in a 45-minute group fitness class, while activity energy expenditure (AEE) was continuously measured by indirect calorimetry (K5, Cosmed, Rome, Italy). In the CON session, participants remained comfortably seated for 45 minutes, maintaining a good posture. After each group fitness class, participants immediately returned to the examination table and recovered in the supine position for 30 minutes, during which local and regional stiffness, HRV, and baroreflex sensitivity (BRS) were re-evaluated at 10-, 20-, and 30-minute intervals during recovery and compared to those at rest. Participants were blinded to the order of the experimental interventions until arrival at the laboratory. All sessions were conducted in the morning to minimize potential diurnal variation. Participants were also instructed not to ingest any food or drink (except water) 4 hours before the sessions and to avoid alcohol, caffeine, and exercise for at least 24 hours preceding each session.
Based on a medium effect size of 0.154 derived from published changes in aortic PWV within-between modes of exercise (23), an a priori power analysis suggested that 22 participants were required (11 per group) to detect significant differences within-between groups, conditions, and time points (1-β = 80%, α = 0.05).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Parallel group crossover randomized trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Other: Bike group fitness class |
| Resistance Exercise | Experimental | Other: Pump Power |
| Combined Exercise | Experimental | Other: Global Training |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physically active, as assessed by the International Physical Activity Questionnaire (IPAQ)
- Experience in both aerobic and resistance exercise (∼3-4 times/week, for more than 3 months).
- Healthy or perceived to be healthy based on the sport's medical examination or the preparticipation screening process, Physical Activity Readiness Questionnaire for Everyone (PARQ+).
Key exclusion criteria (6 listed)
- Any form of cardiovascular disease
- More than one cardiovascular disease risk factor
- Resting hypertension (SBP \>140 mmHg, DBP \> 90 mmHg)
- Any prescription medication use that may influence vascular and autonomic response to exercise
- Being an athlete
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 |
|---|---|---|
| Bike group fitness classComprised a rhythmic indoor cycling session, characterized by fluctuations in intensity corresponding to changes in position, music rhythm, cadence, and revolutions per minute. Participants were instructed to strictly follow verbal cues from the instructor, adjusting cycling cadence and resistance as directed, for 45 minutes. | Other | Aerobic Exercise |
| Pump PowerEntails a comprehensive total-body weight-training program with a focus on improving strength, muscular endurance, and overall fitness of large muscle groups. The class, choreographed to music, involved participants performing a combination of barbell, body-weight exercises, and free-weight plates, during 45 minutes. Participants selected weights based on the target muscle group for the specific song or track and their individual fitness goals. | Other | Resistance Exercise |
| Global TrainingIncorporated both aerobic and resistance components, combining athletic movements like running, lunging, and jumping with strength exercises such as barbells, body-weight exercises, and free-weight plates for the large muscle groups, during 45 minutes. | Other | Combined Exercise |
Primary outcome
Changes in Blood Pressure
Time frame: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
Resting brachial blood pressures (systolic and diastolic) were measured in the supine position using an automated oscillometric cuff (HEM-907 XL; Omron Corporation, Japan). Two measurements were taken, and the average was recorded for analysis. Pulse pressure was calculated as the difference between systolic and diastolic blood pressure. Central blood pressure was assessed by applanation tonometry (Complior 2.0, Alam Medical; Saint Quentin Fallavier, France) from right carotid traces obtained during carotid-femoral pulse wave velocity assessment. The waveforms were averaged, and mean values were taken from a 15-second acquisition window. Carotid waveforms were calibrated using mean arterial pressure measured just before acquisition.
Changes in Heart Rate Variability
Time frame: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
R-R intervals were sampled at 300 Hz using a 5-ECG lead module (Finapres Nova, Finapres Medical Systems). Heart rate variability analyses were conducted offline with FisioSinal software in Matlab. After detecting R-R peaks and removing artifacts, 2-minute time series were created using cubic spline interpolation to estimate time-domain and spectral power indices. Ectopic heartbeats (mean = 1, SD = 6 bpm) were excluded. Time-domain indices included SDNN (overall variability) and RMSSD (cardiovagal modulation). Daubechy-12 wavelet analysis estimated low-frequency (vagal/sympathetic) and high-frequency (cardiovagal) bands.
Changes in Cardiovagal Baroreflex Sensitivity
Time frame: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
Baroreceptor Sensitivity was estimated using the spontaneous sequence method in FisioSinal, focusing on SBP (more than 1 mmHg) and RR interval (more than 4 ms) ramps. SBP was recorded using finger plethysmography (Finapres® NOVA).
Changes in Regional Arterial Stiffness
Time frame: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise
Pressure waveforms from the carotid, femoral, radial, and distal arteries were captured simultaneously using applanation tonometry (Complior 2.0, Alam Medical; Saint Quentin Fallavier, France). The distance between pulse sites was measured and entered into the software, with carotid-femoral distance corrected by a 0.8 factor. Sensors were positioned for the carotid and radial arteries, while femoral and distal posterior tibial arteries were held manually. After obtaining 10 carotid pulse waveforms, simultaneous recording of carotid, femoral, radial, and distal posterior tibial pressure curves occurred. Transit time between waveforms was calculated using the foot-to-foot algorithm. Pulse wave velocity from carotid to femoral, carotid to radial, and carotid to distal posterior tibial arteries were used as indices of central and peripheral arterial stiffness.
1 secondary outcome
Energy Expenditure
Time frame: Before and throughout the group fitness classes
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 27 Sep 2024.
- Results publication: PubMed 35508200Maroco JL, Pinto M, Laranjo S, Santa-Clara H, Fernhall B, Melo X. Cardiovagal Modulation in Young and Older Male Adults Following Acute Aerobic Exercise. Int J Sports Med. 2022 Oct;43(11):931-940. doi: 10.1055/a-1843-7974. Epub 2022 May 4.
- Results publication: PubMed 25793148Cunha FA, Midgley AW, Goncalves T, Soares PP, Farinatti P. Parasympathetic reactivation after maximal CPET depends on exercise modality and resting vagal activity in healthy men. Springerplus. 2015 Feb 27;4:100. doi: 10.1186/s40064-015-0882-1. eCollection 2015.
- Results publication: PubMed 25333969Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.
- Results publication: PubMed 28611675Michael S, Graham KS, Davis GM Oam. Cardiac Autonomic Responses during Exercise and Post-exercise Recovery Using Heart Rate Variability and Systolic Time Intervals-A Review. Front Physiol. 2017 May 29;8:301. doi: 10.3389/fphys.2017.00301. eCollection 2017.
- Derived from this study: PubMed 40080484Melo X, Lopes A, Coelho R, Simao B, Oliveira I, Maroco JL, Laranjo S, Fernhall B, Santa-Clara H. Acute effects of commercial group exercise classes on arterial stiffness and cardiovagal modulation in healthy young and middle-aged adults: A crossover randomized trial. PLoS One. 2025 Mar 13;20(3):e0319130. doi: 10.1371/journal.pone.0319130. eCollection 2025.
- Individual participant dataSharing planned: Yes. Data obtained in this study may be provided to qualified researchers with academic interest in vascular responses to resistance training with blood flow restriction. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Xavier Melo, PhD principal investigator
Egas Moniz School of Health & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bike group fitness class, Pump Power and Global Training in people with Ageing and Aerobic Exercise, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 6 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 27 Sep 2024. 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 Portugal. 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?
Changes in Blood Pressure (time frame: Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise). The study lists 4 primary outcomes in all. 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 NCT06616428, which also lists 5 linked publications.
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 27 Sep 2024.