NCT06616428

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

September 22, 2024

Last Update Submit

September 24, 2024

Conditions

Keywords

Arterial stiffnessCardiac autonomic functionGroup exerciseAge differencesEcological validity

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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).

    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.

    Evaluations were conducted at rest before exercise, and at 10, 20, and 30 minutes post-exercise

Secondary Outcomes (1)

  • Energy Expenditure

    Before and throughout the group fitness classes

Study Arms (4)

Aerobic Exercise

EXPERIMENTAL
Other: Bike group fitness class

Resistance Exercise

EXPERIMENTAL
Other: Pump Power

Combined Exercise

EXPERIMENTAL
Other: Global Training

Control

NO INTERVENTION

Interventions

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.

Aerobic Exercise

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.

Resistance Exercise

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.

Combined Exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ginásio Clube Português

Lisbon, Lisbon District, 1250-111, Portugal

Location

Related Publications (5)

  • 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.

    PMID: 35508200BACKGROUND
  • Cunha 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.

    PMID: 25793148BACKGROUND
  • Ashor 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.

    PMID: 25333969BACKGROUND
  • Michael 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.

    PMID: 28611675BACKGROUND
  • Melo 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.

Study Officials

  • Xavier Melo, PhD

    Egas Moniz School of Health & Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Outcomes were assed by the same experts in every time point. Participants, evaluators and fitness instructors were blinded until arrival of the participant for each visit.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Parallel group crossover randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 27, 2024

Study Start

January 6, 2020

Primary Completion

November 26, 2021

Study Completion

March 11, 2022

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact xmelo@egasmoniz.edu.pt

Locations