Effectiveness of Inspiratory Muscle Training With Slow Breathing in Elderly With ISH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Inspiratory Muscle Training With Antihypertensive Breathing Technique on Lung and Exercise Capacity in Elderly With Isolated Systolic Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Other: Inspiratory Muscle Training
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Good communication and co operation Independent physical activity Stable controlled hypertension Exclusion Criteria: Essential isolated systolic hypertension stage III or secondary hypertension History of heart disease such as coronary artery disease myocardial infarction History of respiratory disease such as asthma chronic bronchitis History of neuromuscular disease such as muscle weakness cerebrovascular disease History of renal disease Exercise limited by pain

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle Training (IMT)<br>Subjects in the inspiratory muscle training (IMT) group will perform loaded deep breathing exercise at 6 breaths/min using BreatheMaxยฎ device. The IMT protocol at 6 breathing rate (inspiratory time = 4 seconds and expiratory time = 6 seconds) with load at 25 percent of MIP for eighth weeks. The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks | Other: Inspiratory Muscle Training<br>* Inspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home<br>|
| Placebo Comparator: Control<br>Subjects in the control (CON) group will perform breathing exercise with inspiratory load at 2 cmH2O at 6 breathing rate using one BreatheMAXยฎ device. The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks | Other: Control<br>* Inspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |