Back to resultsSet Volume of Optimal Resistance Exercise to Generate Hypotension
Primary Purpose
Hypertension, Post-Exercise Hypotension, Resistance Training
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Hypertensive subjects treated with antihypertensive medication
- Controlled blood pressure
- Age between 55 and 70 years old
- Sedentary (less than 150 minutes per week of moderate physical activity and/or 75 minutes per week of vigorous physical activity)
- Non-smokers
- Non-alcoholics
- Informed consent
Exclusion Criteria:
- Any kidney, lung, neurological or psychiatric disease
- Unable to perform exercises
- Participation in other physical activity programs during the study or in the previous 3 months
Sites / Locations
- Primary Health-Care Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
3 sets of resistance exercise
6 sets of resistance exercise
9 sets of resistance exercise
Rest
Arm Description
Outcomes
Primary Outcome Measures
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Blood pressure
Secondary Outcome Measures
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03957746
Brief Title
Set Volume of Optimal Resistance Exercise to Generate Hypotension
Official Title
Set Volume of Optimal Resistance Exercise to Generate Hypotension in Hypertensive Elderly Subjects: a Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the volume of optimal resistance exercise to generate postexercise hypotension after performing a single exercise in hypertensive elderly subjects. 20 subjects will perform 1 control session and 3 resistance training sessions with different volume: 3, 6 and 9 sets
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Post-Exercise Hypotension, Resistance Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3 sets of resistance exercise
Arm Type
Experimental
Arm Title
6 sets of resistance exercise
Arm Type
Experimental
Arm Title
9 sets of resistance exercise
Arm Type
Experimental
Arm Title
Rest
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
Baseline
Title
Blood pressure
Time Frame
Immediately after the end of resistance training session
Title
Blood pressure
Time Frame
30 minutes after the end of resistance training session
Title
Blood pressure
Time Frame
60 minutes after the end of resistance training session
Title
Blood pressure
Time Frame
4 hours after the end of resistance training session
Title
Blood pressure
Time Frame
5 hours after the end of resistance training session
Title
Blood pressure
Time Frame
6 hours after the end of resistance training session
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
Baseline
Title
Heart rate
Time Frame
Immediately after the end of resistance training session
Title
Heart rate
Time Frame
30 minutes after the end of resistance training session
Title
Heart rate
Time Frame
60 minutes after the end of resistance training session
Title
Heart rate
Time Frame
4 hours after the end of resistance training session
Title
Heart rate
Time Frame
5 hours after the end of resistance training session
Title
Heart rate
Time Frame
6 hours after the end of resistance training session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertensive subjects treated with antihypertensive medication
Controlled blood pressure
Age between 55 and 70 years old
Sedentary (less than 150 minutes per week of moderate physical activity and/or 75 minutes per week of vigorous physical activity)
Non-smokers
Non-alcoholics
Informed consent
Exclusion Criteria:
Any kidney, lung, neurological or psychiatric disease
Unable to perform exercises
Participation in other physical activity programs during the study or in the previous 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Casaña
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joaquín Calatayud
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alba Cuerda
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
Primary Health-Care Center
City
Rocafort
State/Province
Valencia
ZIP/Postal Code
46111
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Set Volume of Optimal Resistance Exercise to Generate Hypotension
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