HypertensionNCT01743183
Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness
A study testing Threshold in people with Hypertension, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
This study aims to evaluate pulmonary function and respiratory muscle strength in a group of elderly women with hypertension before and after a respiratory muscle training. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Nov 2012
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of hypertension controlled by antihypertensive;
- aged between 60 and 80 years;
- absence of dementia or cognitive impairments that limit tests;
- absence of recent myocardial infarction;
- absence of musculoskeletal limitations that limit tests;
- availability of time on training days.
Who cannot join
- clinical instability;
- inability to perform any test.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte
About this study
This study aims to evaluate pulmonary function and respiratory muscle strength in a group of elderly women with hypertension before and after a respiratory muscle training.
Read the detailed description
It is a respiratory muscle training using the Threshold for 5 weeks, with a load of 30% of maximal inspiratory pressure obtained in manometer for 30 minutes daily. Furthermore, the assessment includes: test 6-minute walk, the quality of life questionnaire, MINICHAL, the IPAQ short version, manometer and spirometry.
- Conditions
- Hypertension
- Being tested
- Threshold
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThresholdDevice
The load adjustment was done weekly by a single examiner.
| Study group | Role | What they receive |
|---|---|---|
| threshold | Experimental | Held inspiratory muscle strengthening for 5 weeks with Threshold, charging 30% of maximal inspiratory pressure, 7 days a week, one supervised and unsupervised 6. Receives: Device: Threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
manovacuometry
Evaluates indirectly respiratory muscle strength.
Measured: 6 weeks
Secondary outcomes (1)
spirometry
Assesses lung function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionNov 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for research support from the state of Rio Grande do Norte (FAPERN)
- Responsible party
- Principal investigator, Patra-cia Angelica de Miranda Silva Nogueira, Universidade Federal do Rio Grande do Norte
- Investigators
- Patrícia Nogueira, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743183
- Sponsor's protocol ID
- 05135912.8.0000.5537
- Status last verified
- Dec 2012
- First submitted
- 12 Nov 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness
- ClinicalTrials.gov ID
- NCT01743183
- Acronym / sponsor ID
- 05135912.8.0000.5537
- Conditions
- Hypertension
- Keywords
- hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Foundation for research support from the state of Rio Grande do Norte (FAPERN)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Dec 2012 (estimated)
- 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 aims to evaluate pulmonary function and respiratory muscle strength in a group of elderly women with hypertension before and after a respiratory muscle training.
Detailed description
It is a respiratory muscle training using the Threshold for 5 weeks, with a load of 30% of maximal inspiratory pressure obtained in manometer for 30 minutes daily. Furthermore, the assessment includes: test 6-minute walk, the quality of life questionnaire, MINICHAL, the IPAQ short version, manometer and spirometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| threshold | Experimental | Device: ThresholdHeld inspiratory muscle strengthening for 5 weeks with Threshold, charging 30% of maximal inspiratory pressure, 7 days a week, one supervised and unsupervised 6. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of hypertension controlled by antihypertensive;
- aged between 60 and 80 years;
- absence of dementia or cognitive impairments that limit tests;
- absence of recent myocardial infarction;
- absence of musculoskeletal limitations that limit tests;
Key exclusion criteria (2 listed)
- clinical instability;
- inability to perform any test.
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 |
|---|---|---|
| ThresholdThe load adjustment was done weekly by a single examiner. | Device | threshold |
Primary outcome
manovacuometry
Time frame: 6 weeks
Evaluates indirectly respiratory muscle strength.
1 secondary outcome
spirometry
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 6 Dec 2012.
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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.
Patrícia Nogueira principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold in people with Hypertension, run by Universidade Federal do Rio Grande do Norte 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 6 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 6 Dec 2012. 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?
manovacuometry (time frame: 6 weeks). 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 6 Dec 2012.