HypertensionVARIABILITA'NCT04282499
Effects of Exercise Training on Blood Pressure Variability
A study testing combined exercise and aerobic exercise in people with Hypertension and Cardiac Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
A Randomized clinical evaluation of the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Cardiac Disease
- What is being tested?
- combined exercise and aerobic exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jan 2019to 1 Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to understand the study protocol instructions
- ability to sign the informed consent
Who cannot join
- sever cardio-vascular condition
- cognitive deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of 12-weeks of Aerobic Versus Combined Exercise Training on Short Term Blood Pressure Variability in Patients With Hypertension
A Randomized clinical evaluation of the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).
Read the detailed description
This study will be a randomized trial, with two intervention arms: 1) Aerobic training (AT) and 2) Combined training (CT) groups. The planned training period will be 12 weeks for each group. Patients of both groups will be asked to exercise three times a week. Each session will last 80 minutes for each group. Population: We will includ 60 male subjects ≥ 45 years old, with established diagnosis of hypertension (of at least one year), treated with pharmacological therapy and with resting BP values under acceptable control (systolic BP <150 mmHg; diastolic BP < 90 mmHg) at admission. All groups of anti-hypertensive drugs will be admitted; there will be no restriction on the number of anti-hypertensive drugs taken by the patients. Sustained BP increase during the exercise protocol will be managed with the administration of furosemide (25-50 mg/daily). Patients who will need further pharmacological interventions for lowering BP will be withdrawn from the study. The following exclusion criteria will be adopted: secondary hypertension; significant heart valve diseases; signs and or symptoms of myocardial ischemia during ergometric test; neurological and or orthopedic conditions contraindicating or limiting ET; significant COPD (FEV1 <50%), or symptomatic peripheral arterial occlusive disease. Patients will be randomly assigned on 1:1 basis to either AT or CT group. The randomization code will be developed with a computer random-number generator to select random permuted blocks.
Exercise training protocols: AT group: every exercise session will include 10 min of warm-up, cool-down and flexibility exercises and 60 min of aerobic exercise with cycling and treadmill at 60-70% of VO2 peak.
CT group: patients will perform aerobic and resistance exercises in the same session. In order to balance the total amount of exercise, exercise sessions of the CT group will be organized as follow: 40 minutes of aerobic training with cycling and treadmill at 60-70% of VO2 peak; 20 minutes of resistance training including the following exercises: leg press and extension, shoulder press, chest press, low row and vertical traction. all the subjects Each strength exercise will be performed by patients at 60% of their maximal voluntary contraction. Patients of CT group will performed also 10 min of warm-up, cool-down and flexibility exercises. The one maximum repetition test (1RM) will be used to determine the RE load.
- Conditions
- Hypertension, Cardiac Disease
- Being tested
- combined exercise, aerobic exercise
- Keywords
- Hypertension, Cardiac Disease, Excercise
- Medical subject headings
- Hypertension, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined exerciseProcedure or surgery
Patients will be undergone to aerobic exercises in addition to the resistance training.
aerobic exerciseProcedure or surgery
Patients will be trained through the aerobic exercises only.
| Study group | Role | What they receive |
|---|---|---|
| combined exercise | Experimental | combined exercise (aerobic+resistance training) Receives: Procedure: combined exercise |
| aerobic exercise | Active comparator | aerobic exercise only Receives: Procedure: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24/h systolic blood pressure variability
Systolic BP variability will be calculated through the formula of average real variability. This formula will be applied to the measures of BP obtained during 24 ambulatory BP monitoring
Measured: At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
Secondary outcomes (1)
Change in 24/h systolic and diatolic blood pressure values
Measures of BP obtained during 24 ambulatory BP monitoring
Measured: At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start4 Jan 2019
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinical evaluating the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Caminiti, MD, Principal investigator, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282499
- Sponsor's protocol ID
- RP 24/18
- Acronym
- VARIABILITA'
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of 12-weeks of Aerobic Versus Combined Exercise Training on Short Term Blood Pressure Variability in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04282499
- Acronym / sponsor ID
- VARIABILITA' / RP 24/18
- Conditions
- Hypertension, Cardiac Disease
- Keywords
- Hypertension, Cardiac Disease, Excercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Feb 2020 (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.
A Randomized clinical evaluation of the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).
Detailed description
This study will be a randomized trial, with two intervention arms: 1) Aerobic training (AT) and 2) Combined training (CT) groups. The planned training period will be 12 weeks for each group. Patients of both groups will be asked to exercise three times a week. Each session will last 80 minutes for each group. Population: We will includ 60 male subjects ≥ 45 years old, with established diagnosis of hypertension (of at least one year), treated with pharmacological therapy and with resting BP values under acceptable control (systolic BP <150 mmHg; diastolic BP < 90 mmHg) at admission. All groups of anti-hypertensive drugs will be admitted; there will be no restriction on the number of anti-hypertensive drugs taken by the patients. Sustained BP increase during the exercise protocol will be managed with the administration of furosemide (25-50 mg/daily). Patients who will need further pharmacological interventions for lowering BP will be withdrawn from the study. The following exclusion criteria will be adopted: secondary hypertension; significant heart valve diseases; signs and or symptoms of myocardial ischemia during ergometric test; neurological and or orthopedic conditions contraindicating or limiting ET; significant COPD (FEV1 <50%), or symptomatic peripheral arterial occlusive disease. Patients will be randomly assigned on 1:1 basis to either AT or CT group. The randomization code will be developed with a computer random-number generator to select random permuted blocks.
Exercise training protocols: AT group: every exercise session will include 10 min of warm-up, cool-down and flexibility exercises and 60 min of aerobic exercise with cycling and treadmill at 60-70% of VO2 peak.
CT group: patients will perform aerobic and resistance exercises in the same session. In order to balance the total amount of exercise, exercise sessions of the CT group will be organized as follow: 40 minutes of aerobic training with cycling and treadmill at 60-70% of VO2 peak; 20 minutes of resistance training including the following exercises: leg press and extension, shoulder press, chest press, low row and vertical traction. all the subjects Each strength exercise will be performed by patients at 60% of their maximal voluntary contraction. Patients of CT group will performed also 10 min of warm-up, cool-down and flexibility exercises. The one maximum repetition test (1RM) will be used to determine the RE load.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- clinical evaluating the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).
| Arm | Type | Receives |
|---|---|---|
| combined exercise | Experimental | Procedure: combined exercisecombined exercise (aerobic+resistance training) |
| aerobic exercise | Active comparator | Procedure: aerobic exerciseaerobic exercise only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability to understand the study protocol instructions
- ability to sign the informed consent
Key exclusion criteria (2 listed)
- sever cardio-vascular condition
- cognitive deficit
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 |
|---|---|---|
| combined exercisePatients will be undergone to aerobic exercises in addition to the resistance training. | Procedure or surgery | combined exercise |
| aerobic exercisePatients will be trained through the aerobic exercises only. | Procedure or surgery | aerobic exercise |
Primary outcome
Change in 24/h systolic blood pressure variability
Time frame: At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
Systolic BP variability will be calculated through the formula of average real variability. This formula will be applied to the measures of BP obtained during 24 ambulatory BP monitoring
1 secondary outcome
Change in 24/h systolic and diatolic blood pressure values
Time frame: At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
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 10 Apr 2024.
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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.
Giuseppe Caminiti, MD principal investigator
IRCCS San Raffaele Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined exercise and aerobic exercise in people with Hypertension and Cardiac Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 2 inclusion and 2 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 10 Apr 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 Italy. 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?
Change in 24/h systolic blood pressure variability (time frame: At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.