NCT04763629

Brief Summary

The study aim is to compare the effects produced by two different exercise training modalities on short-term blood pressure variability and atrial function evaluated by speckle-tracking echocardiography in hypertensive patients with ischemic heart disease. 50 males patients will be randomized to interval combined training (ICT) o0r aerobic continuous combined training (CCT) botrg including aerobic and resistance exercises. The training period will last 12 weeks. The protocol will provide two different assessment of atrial function: -acute: after a single session of exercise; - 12 weeks: at the end of exercise training protocols. 24/h blood pressure variability will be performed before starting the training programs and at 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

February 18, 2021

Last Update Submit

January 22, 2026

Conditions

HypertensionCoronary Artery Disease

Keywords

atrial function; hypertension; coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • changes on peak atrial longitudinal strain

    between-groups comparison of exercise-induced changes on peak atrial longitudinal strain

    12 weeks

Secondary Outcomes (1)

  • changes on left ventricle global longitudinal strain

    12 weeks

Study Arms (2)

Interval Combined Training (ICT)

EXPERIMENTAL

Patients randomized to this group will perform aerobic exercise on the stationary cycle ergometer using an interval protocol consisting of alternating bouts of 5 minutes at 80-90% of VO₂ peak and 10 minutes at 50-60% of VO₂ peak. This sequence will be repeated three times, resulting in a total aerobic exercise duration of 45 minutes. Then they will perform dynamic resistance exercise lasting 35 minutes at 60% of 1-repetition maximum (1-RM)

Other: Physical exercise

Continuous Combined Training (CCT)

EXPERIMENTAL

Patients randomized to this group will perform 45 minutes of cycling at a constant heart rate corresponding to 60-70% of VO₂ peak as determined during cardiopulmonary test. Then they will perform dynamic resistance exercise at 60% of 1-RM involving arms and legs for 35 minutes.

Other: Physical exercise

Interventions

Physical exerciseOTHER

Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.

Continuous Combined Training (CCT)Interval Combined Training (ICT)

Eligibility Criteria

Age45 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension;
  • Coronary artery disease;
  • Age over 45 years;
  • Male gender

You may not qualify if:

  • Secondary hypertension;
  • Significant heart valve diseases;
  • Hypertrophic cardiomyopathy;
  • Signs and/or symptoms of myocardial ischemia during an ergometric test;
  • Uncontrolled arrhythmia;
  • Neurological and or orthopedic conditions contraindicating or limiting exercises;
  • Significant chronic obstructive pulmonary disease (FEV1 \<50%),
  • Symptomatic peripheral arterial disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Pisana

Rome, 00163, Italy

Location

MeSH Terms

Conditions

HypertensionCoronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Giuseppe Caminiti

    IRCCS San Raffaele Rome

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

January 20, 2021

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

IT(1)