Effects of Exercise Training on Blood Pressure Variability
VARIABILITA'
Comparative Effects of 12-weeks of Aerobic Versus Combined Exercise Training on Short Term Blood Pressure Variability in Patients With Hypertension
1 other identifier
interventional
22
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Jan 2019
Shorter than P25 for not_applicable hypertension
1 active site
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 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 24, 2020
CompletedApril 10, 2024
February 1, 2020
10 months
February 17, 2020
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
Study Arms (2)
combined exercise
EXPERIMENTALcombined exercise (aerobic+resistance training)
aerobic exercise
ACTIVE COMPARATORaerobic exercise only
Interventions
Patients will be undergone to aerobic exercises in addition to the resistance training.
Patients will be trained through the aerobic exercises only.
Eligibility Criteria
You may qualify if:
- ability to understand the study protocol instructions
- ability to sign the informed consent
You may not qualify if:
- sever cardio-vascular condition
- cognitive deficit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Raffaele Pisana
Rome, RM, 00166, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Caminiti, MD
IRCCS San Raffaele Roma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients are not aware to the study design.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 24, 2020
Study Start
January 4, 2019
Primary Completion
November 1, 2019
Study Completion
December 1, 2019
Last Updated
April 10, 2024
Record last verified: 2020-02