NCT06174870

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 1, 2023

Last Update Submit

December 14, 2023

Conditions

ElderlyHypertension

Keywords

ElderlyHypertensionInspiratory muscle training

Outcome Measures

Primary Outcomes (3)

  • 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"

Study Arms (2)

Control

NO INTERVENTION

Control group

Intervention

EXPERIMENTAL

IMT group

Other: Inspiratory muscle training

Interventions

Inspiratory muscle trainingOTHER

Inhale against 60% of Maximal inspiratory pressure 30breaths/day 5days/week for 6 weeks

Intervention

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly with hypertension
  • BMI 18.5 - 29.9 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Phayao

Nai Muang, Changwat Phayao, 56000, Thailand

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

EAKARACH WONGSAYA, Master degree

CONTACT

+66 0840468486eakarach.wo@up.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 18, 2023

Study Start

December 10, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)