ElderlyIMTNCT06174870
The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension
A study testing Inspiratory muscle training in people with Elderly and Hypertension, run by University of Phayao at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to investigate in elderly with hypertension . The main question it aim to answer is: Investigate the effect of inspiratory muscle training on inspiratory muscle strength, blood pressure and physical capacity Participants will be random in to 2 group and measure baseline. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Elderly, Hypertension
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 10 Dec 2023to 28 Feb 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly with hypertension
- BMI 18.5 - 29.9 kg/m2
Who cannot join
- Unstable angina
- Resting heart rate more than 120 bpm
- Resting blood pressure more than 180/100 mmHg
- Other abnormality with contribute to IMT and variable measurement
Trial locations and contacts
1 site in 1 country.
Thailand1 site
University Of Phayao
Nai Muang, Changwat Phayao, 56000
EAKARACH WONGSAYA, +66840468486, eakarach.wo@up.ac.th
Eakarach Wongsaya
About this study
The goal of this clinical trial is to investigate in elderly with hypertension . The main question it aim to answer is:
- Investigate the effect of inspiratory muscle training on inspiratory muscle strength, blood pressure and physical capacity
Participants will be random in to 2 group and measure baseline. Control group will advise to maintain normal daily life activity. and Intervention group will receive inspiratory muscle training (IMT) with 60% of Maximal inspiratory pressure. Intervention group will perform IMT 30 breaths/day, 5 days a week for 6 weeks.
after 6 weeks both group will remeasure variable again as post test
- Conditions
- Elderly, Hypertension
- Being tested
- Inspiratory muscle training
- Keywords
- Elderly, Hypertension, Inspiratory muscle training
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Inhale against 60% of Maximal inspiratory pressure 30breaths/day 5days/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group |
| Intervention | Experimental | IMT group Receives: Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory pressure
Measured: "baseline, pre-intervention" and "6 weeks"
Systolic and diastolic blood pressure
blood pressure will include systolic and diastolic blood pressure
Measured: "baseline, pre-intervention" and "6 weeks"
Six-minute walk distance
Measured: "baseline, pre-intervention" and "6 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start10 Dec 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Phayao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EAKARACH WONGSAYA, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174870
- Sponsor's protocol ID
- UPhayao
- Acronym
- IMT
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension
- ClinicalTrials.gov ID
- NCT06174870
- Acronym / sponsor ID
- IMT / UPhayao
- Conditions
- Elderly, Hypertension
- Keywords
- Elderly, Hypertension, Inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PhayaoUniversity, hospital or other
- Study start
- 10 Dec 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 18 Dec 2023 (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 goal of this clinical trial is to investigate in elderly with hypertension . The main question it aim to answer is:
- Investigate the effect of inspiratory muscle training on inspiratory muscle strength, blood pressure and physical capacity
Participants will be random in to 2 group and measure baseline. Control group will advise to maintain normal daily life activity. and Intervention group will receive inspiratory muscle training (IMT) with 60% of Maximal inspiratory pressure. Intervention group will perform IMT 30 breaths/day, 5 days a week for 6 weeks.
after 6 weeks both group will remeasure variable again as post test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group |
| Intervention | Experimental | Other: Inspiratory muscle trainingIMT group |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly with hypertension
- BMI 18.5 - 29.9 kg/m2
Key exclusion criteria (4 listed)
- Unstable angina
- Resting heart rate more than 120 bpm
- Resting blood pressure more than 180/100 mmHg
- Other abnormality with contribute to IMT and variable measurement
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 |
|---|---|---|
| Inspiratory muscle trainingInhale against 60% of Maximal inspiratory pressure 30breaths/day 5days/week for 6 weeks | Other | Intervention |
Primary outcome
Maximal Inspiratory pressure
Time frame: "baseline, pre-intervention" and "6 weeks"
Systolic and diastolic blood pressure
Time frame: "baseline, pre-intervention" and "6 weeks"
blood pressure will include systolic and diastolic blood pressure
Six-minute walk distance
Time frame: "baseline, pre-intervention" and "6 weeks"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Elderly
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Elderly and Hypertension, run by University of Phayao at 1 site in Thailand.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EAKARACH WONGSAYA, Master degree (+66 0840468486, eakarach.wo@up.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory pressure (time frame: "baseline, pre-intervention" and "6 weeks"). The study lists 3 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 18 Dec 2023.