The Effect of Inspiratory Muscle Training on Blood Pressu... | NCT06174870

Studies
The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension

NCT06174870

Sponsor

University of Phayao

Status

Unknown status

Last Update Posted

Dec 18, 2023Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Elderly
Hypertension

Interventions

Inspiratory muscle training

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2023Estimated

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

Feb 28, 2024Estimated

First Submitted Date

Dec 1, 2023

First Submission Date that Met QC Criteria

Dec 14, 2023

First Posted Date

Dec 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Control group
Intervention	Experimental	IMT group	Other: Inspiratory muscle training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inspiratory muscle training	Other	Inhale against 60% of Maximal inspiratory pressure 30breaths/day 5days/week for 6 weeks	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal Inspiratory pressure		"baseline, pre-intervention" and "6 weeks"
Systolic and diastolic blood pressure	blood pressure will include systolic and diastolic blood pressure	"baseline, pre-intervention" and "6 weeks"
Six-minute walk distance		"baseline, pre-intervention" and "6 weeks"

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elderly with hypertension
BMI 18.5 - 29.9 kg/m2

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
EAKARACH WONGSAYA, Master degree	Contact	+66 0840468486		eakarach.wo@up.ac.th

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Of Phayao		Nai Muang	Changwat Phayao	56000	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided