HypertensionNCT03957746
Set Volume of Optimal Resistance Exercise to Generate Hypotension
A study testing Resistance training in people with Hypertension and Post-Exercise Hypotension, run by University of Valencia at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Hypertension, Post-Exercise Hypotension, Resistance Training
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2020to 3 Oct 2021
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Set Volume of Optimal Resistance Exercise to Generate Hypotension in Hypertensive Elderly Subjects: a Crossover Study
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
- Conditions
- Hypertension, Post-Exercise Hypotension, Resistance Training
- Being tested
- Resistance training
- Medical subject headings
- Hypertension, Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
| Study group | Role | What they receive |
|---|---|---|
| 3 sets of resistance exercise | Experimental | Not described Receives: Other: Resistance training |
| 6 sets of resistance exercise | Experimental | Not described Receives: Other: Resistance training |
| 9 sets of resistance exercise | Experimental | Not described Receives: Other: Resistance training |
| Rest | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Baseline
Blood pressure
Measured: Immediately after the end of resistance training session
Blood pressure
Measured: 30 minutes after the end of resistance training session
Blood pressure
Measured: 60 minutes after the end of resistance training session
Blood pressure
Measured: 4 hours after the end of resistance training session
Blood pressure
Measured: 5 hours after the end of resistance training session
Blood pressure
Measured: 6 hours after the end of resistance training session
Secondary outcomes (7)
Heart rate
Measured: Baseline
Heart rate
Measured: Immediately after the end of resistance training session
Heart rate
Measured: 30 minutes after the end of resistance training session
Heart rate
Measured: 60 minutes after the end of resistance training session
Heart rate
Measured: 4 hours after the end of resistance training session
Heart rate
Measured: 5 hours after the end of resistance training session
Heart rate
Measured: 6 hours after the end of resistance training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start13 May 2020
- Primary completion1 Oct 2020
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Casaña Granell, University of Valencia
- Investigators
- Jose Casaña, Principal investigator, University of ValenciaJoaquín Calatayud, Study chair, University of ValenciaAlba Cuerda, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957746
- Sponsor's protocol ID
- 000018819
- Status last verified
- Oct 2021
- First submitted
- 16 May 2019
- Last updated
- 5 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gargallo P, Casana J, Suso-Marti L, Cuenca-Martinez F, Lopez-Bueno R, Andersen LL, Lopez-Bueno L, Cuerda-Del Pino A, Calatayud J. Minimal Dose of Resistance Exercise Required to Induce Immediate Hypotension Effect in Older Adults with Hypertension: Randomized Cross-Over Controlled Trial. Int J Environ Res Public Health. 2022 Oct 31;19(21):14218. doi: 10.3390/ijerph192114218.
PubMed 36361100
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Set Volume of Optimal Resistance Exercise to Generate Hypotension in Hypertensive Elderly Subjects: a Crossover Study
- ClinicalTrials.gov ID
- NCT03957746
- Acronym / sponsor ID
- 000018819
- Conditions
- Hypertension, Post-Exercise Hypotension, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 21 May 2019 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3 sets of resistance exercise | Experimental | Other: Resistance training |
| 6 sets of resistance exercise | Experimental | Other: Resistance training |
| 9 sets of resistance exercise | Experimental | Other: Resistance training |
| Rest | No intervention | – |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Resistance training3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM) | Other | 3 sets of resistance exercise, 6 sets of resistance exercise, 9 sets of resistance exercise |
Primary outcome
Blood pressure
Time frame: Baseline
Blood pressure
Time frame: Immediately after the end of resistance training session
Blood pressure
Time frame: 30 minutes after the end of resistance training session
Blood pressure
Time frame: 60 minutes after the end of resistance training session
Blood pressure
Time frame: 4 hours after the end of resistance training session
Blood pressure
Time frame: 5 hours after the end of resistance training session
Blood pressure
Time frame: 6 hours after the end of resistance training session
7 secondary outcomes
Heart rate
Time frame: Baseline
Heart rate
Time frame: Immediately after the end of resistance training session
Heart rate
Time frame: 30 minutes after the end of resistance training session
Heart rate
Time frame: 60 minutes after the end of resistance training session
Heart rate
Time frame: 4 hours after the end of resistance training session
Heart rate
Time frame: 5 hours after the end of resistance training session
Heart rate
Time frame: 6 hours after the end of resistance training session
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 5 Oct 2021.
- Derived from this study: PubMed 36361100Gargallo P, Casana J, Suso-Marti L, Cuenca-Martinez F, Lopez-Bueno R, Andersen LL, Lopez-Bueno L, Cuerda-Del Pino A, Calatayud J. Minimal Dose of Resistance Exercise Required to Induce Immediate Hypotension Effect in Older Adults with Hypertension: Randomized Cross-Over Controlled Trial. Int J Environ Res Public Health. 2022 Oct 31;19(21):14218. doi: 10.3390/ijerph192114218.
- Individual participant dataSharing planned: No
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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.
Jose Casaña principal investigator
University of Valencia
Joaquín Calatayud study chair
University of Valencia
Alba Cuerda study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Hypertension and Post-Exercise Hypotension, run by University of Valencia at 1 site in Spain.
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 7 inclusion and 3 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 5 Oct 2021. 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 Spain. 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?
Blood pressure (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957746, which also lists 1 linked publication.
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 5 Oct 2021.