Blood PressureNCT05310006
Acute Effects of Low and High-Speed Resistance Training on Blood Pressure in Older Adults: A Crossover Study
A study testing Exercise in people with Blood Pressure and Frailty, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The first study was a randomized crossover trial that compared the acute effects of High Speed Resistance Exercise (HSRE) and Traditional Resistance Exercise (TRE) on blood pressure parameters in a sample of frail older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Frailty
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 31 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥60 years; Frail according to Fried's criteria (Fried et al., 2009); Possessed sufficient physical and cognitive abilities to perform all exercises required by the protocol; Had a physician authorization to participate of exercise programs.
Who cannot join
- Participation in a structured physical exercise training program in the past six months; Prescription of hormone replacement therapy and/or psychotropic drugs; Presence of any acute cardiovascular event (e.g., myocardial infarction) or complication in the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
The first study was a randomized crossover trial that compared the acute effects of High Speed Resistance Exercise (HSRE) and Traditional Resistance Exercise (TRE) on blood pressure parameters in a sample of frail older adults. Participants performed three experimental sessions (i.e., HSRE, TRE, and a control session [CS]) in a random order and separated from one another by seven days (standard deviation [±] 1 day). Food consumption was maintained constant during 48 h prior to the exercise session and a standard breakfast was offered 60-90 min before the beginning of the experimental sessions. The pharmacological therapy was kept constant during the whole study, and participants took their anti-hypertensive medication at the same time in all experimental days as prescribed by their physician.
- Conditions
- Blood Pressure, Frailty
- Being tested
- Exercise
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise sessions were performed in the morning (07:00 am-12:00 am) under the supervision of at least two fitness instructors in the rehabilitation unit of the nursing home.HSRE and TRE were designed according to the peculiarities of each type of resistance exercise (Chodzko-Zajko et al., 2009). During TRE, participants performed four sets of 8-10 repetitions at 70-75% of the maximal strength. The concentric and eccentric phases were carried out for 2 s. For HSRE, exercises were performed eight times (sets) with 4-5 repetitions at 70-75% of the maximal strength. The concentric phase was performed as fast as possible, and the eccentric phase was carried out for 2 s. Bilateral calf raise was performed using the same load as unilateral knee extension.
| Study group | Role | What they receive |
|---|---|---|
| High Speed Resistance Exercise (HSRE) | Experimental | Exercise sessions performed using eight times (sets) with 4-5 repetitions at 70-75% of the maximal strength. The concentric phase was performed as fast as possible, and the eccentric phase was carried out for 2 s. Receives: Other: Exercise |
| Traditional Resistance Exercise (TRE) | Experimental | Exercise sessions were performed using four sets of 8-10 repetitions at 70-75% of the maximal strength. The concentric and eccentric phases were carried out for 2 s. Receives: Other: Exercise |
| Control Session (CS) | No intervention | Participants remained seated in a comfortable chair listening to music and/or talking with study investigators for approximately 30 min. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood Pressure
Measured: Immediately after the end of the experimental sessions
Blood Pressure
Blood Pressure
Measured: 10 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Measured: 20 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Measured: 30 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Measured: 50 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Measured: 60 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Measured: 24 hours after the end of the experimental sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hélio José Coelho Júnior, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310006
- Sponsor's protocol ID
- 20021919
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Low and High-Speed Resistance Training on Blood Pressure in Older Adults: A Crossover Study
- ClinicalTrials.gov ID
- NCT05310006
- Acronym / sponsor ID
- 20021919
- Conditions
- Blood Pressure, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Apr 2022 (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.
The first study was a randomized crossover trial that compared the acute effects of High Speed Resistance Exercise (HSRE) and Traditional Resistance Exercise (TRE) on blood pressure parameters in a sample of frail older adults. Participants performed three experimental sessions (i.e., HSRE, TRE, and a control session [CS]) in a random order and separated from one another by seven days (standard deviation [±] 1 day). Food consumption was maintained constant during 48 h prior to the exercise session and a standard breakfast was offered 60-90 min before the beginning of the experimental sessions. The pharmacological therapy was kept constant during the whole study, and participants took their anti-hypertensive medication at the same time in all experimental days as prescribed by their physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Speed Resistance Exercise (HSRE) | Experimental | Other: ExerciseExercise sessions performed using eight times (sets) with 4-5 repetitions at 70-75% of the maximal strength. The concentric phase was performed as fast as possible, and the eccentric phase was carried out for 2 s. |
| Traditional Resistance Exercise (TRE) | Experimental | Other: ExerciseExercise sessions were performed using four sets of 8-10 repetitions at 70-75% of the maximal strength. The concentric and eccentric phases were carried out for 2 s. |
| Control Session (CS) | No intervention | –Participants remained seated in a comfortable chair listening to music and/or talking with study investigators for approximately 30 min. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged ≥60 years; Frail according to Fried's criteria (Fried et al., 2009); Possessed sufficient physical and cognitive abilities to perform all exercises required by the protocol; Had a physician authorization to participate of exercise programs.
Key exclusion criteria (1 listed)
- Participation in a structured physical exercise training program in the past six months; Prescription of hormone replacement therapy and/or psychotropic drugs; Presence of any acute cardiovascular event (e.g., myocardial infarction) or complication in the past six 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 |
|---|---|---|
| ExerciseExercise sessions were performed in the morning (07:00 am-12:00 am) under the supervision of at least two fitness instructors in the rehabilitation unit of the nursing home.HSRE and TRE were designed according to the peculiarities of each type of resistance exercise (Chodzko-Zajko et al., 2009). During TRE, participants performed four sets of 8-10 repetitions at 70-75% of the maximal strength. The concentric and eccentric phases were carried out for 2 s. For HSRE, exercises were performed eight times (sets) with 4-5 repetitions at 70-75% of the maximal strength. The concentric phase was performed as fast as possible, and the eccentric phase was carried out for 2 s. Bilateral calf raise was performed using the same load as unilateral knee extension. | Other | High Speed Resistance Exercise (HSRE), Traditional Resistance Exercise (TRE) |
Primary outcome
Blood Pressure
Time frame: Immediately after the end of the experimental sessions
Blood Pressure
Blood Pressure
Time frame: 10 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Time frame: 20 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Time frame: 30 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Time frame: 50 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Time frame: 60 minutes after the end of the experimental sessions
Blood Pressure
Blood Pressure
Time frame: 24 hours after the end of the experimental sessions
Blood Pressure
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 4 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Blood Pressure and Frailty, run by University of Campinas, Brazil at 1 site in Brazil.
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 1 inclusion and 1 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 4 Apr 2022. 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 Brazil. 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: Immediately after the end of the experimental sessions). 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?
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 4 Apr 2022.