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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: Inspiratory Muscle Training; Other: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phailin Tongdee, Master; Phone Number: 0862957922; Email: pang_haru@hotmail.com

Study Locations

• Thailand
  • Khon Kaen
    • Na Muang, Khon Kaen, Thailand, 40002
      • Recruiting
      • Faculty of Associated Medical Sciences
      • Contact: Phailin Tongdee, Master; Phone Number: 0862957922; Email: pang_haru@hotmail.com
      • Contact: Chulee Jones, Docter; Phone Number: 0845164169; Email: joneschulee@gmail.com
      • Principal Investigator: Phailin Tongdee, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory Muscle Training (IMT); 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; Inspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
Placebo Comparator: Control; 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; Inspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Phailin Tongdee, Master, Faculty of Associated Medical Sciences.

Publications and helpful links

General Publications

• 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. doi: 10.1016/s1836-9553(10)70023-0. Erratum In: J Physiother. 2010;56(4):221.
• Ublosakka-Jones C, Tongdee P, Pachirat O, Jones DA. Slow loaded breathing training improves blood pressure, lung capacity and arm exercise endurance for older people with treated and stable isolated systolic hypertension. Exp Gerontol. 2018 Jul 15;108:48-53. doi: 10.1016/j.exger.2018.03.023. Epub 2018 Mar 28.

Helpful Links

• An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HE 581469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No