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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02752217
Other study ID # HE 581469
Secondary ID
Status Recruiting
Phase N/A
First received April 7, 2016
Last updated April 25, 2016
Start date March 2016
Est. completion date September 2018

Study information

Verified date April 2016
Source Khon Kaen University
Contact Phailin Tongdee, Master
Phone 0862957922
Email pang_haru@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in elderly with Isolated systolic hypertension.


Description:

Study the effects of inspiratory muscle training at Low load of 25 % Maximal inspiratory pressure with slow breathing rate at 6 breaths/min with BreatheMAXยฎdevice for 8 weeks at home on inspiratory muscle strength, lung function (slow vital capacity, inspiratory capacity), chest wall expansion, abdominal expansion, exercise capacity by arm ergometry and blood pressure in elderly with Isolated systolic hypertension. who have age 60-80 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date September 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

1. Subjects aged 60 to 80 years of age with an essential isolated systolic hypertension stage I II based on recommendation of JNC VII from primary care units in community and the Outpatient Department of Srinakarind hospital in Khon Kaen province Thailand

2. Good communication and co operation

3. Independent physical activity

4. Stable controlled hypertension

Exclusion Criteria:

1. Essential isolated systolic hypertension stage III or secondary hypertension

2. History of heart disease such as coronary artery disease myocardial infarction

3. History of respiratory disease such as asthma chronic bronchitis

4. History of neuromuscular disease such as muscle weakness cerebrovascular disease

5. History of renal disease

6. Exercise limited by pain

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Inspiratory Muscle Training
Inspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
Control
Inspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home

Locations

Country Name City State
Thailand Faculty of Associated Medical Sciences Na Muang Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Jones CU, Sangthong B, Pachirat O. An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial. J Physiother. 2010;56(3):179-86. Erratum in: J Physiother. 2010;56(4):221. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Maximal inspiratory pressure (MIP) MIP will be measure by Mouth pressure meter (Micro RPM, Micro Medical, Inc., Chatham Maritime, Kent) Baseline and at 8 weeks
Secondary Lung capacity Lung capacity consists of slow vital capacity (SVC), inspiratory capacity (IC). SVC and IC will be measure by a portable computerized spirometer (KoKo spirometer) Baseline and at 8 weeks
Secondary Exercise capacity Exercise capacity by Arm ergometer consists of exercise times, rating of perceived breathlessness (RPB) will examined by Borg scale Baseline and at 8 weeks
Secondary Chest wall expansion and abdominal expansion chest wall expansion and abdominal expansion measured at xiphoid process level and middle between the ambrical and xiphiod process level by use a flexible measuring tape (cm) Baseline and at 8 weeks
Secondary Blood pressure (BP) Blood pressure (BP) at home measured by digital bedside monitor. Accordingly follow ACMS recommended. And BP at laboratory test measured by Bedside monitor. Baseline and at 8 weeks
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