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

Primary Purpose

Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Inspiratory Muscle Training

Control

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Associated Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory Muscle Training (IMT)

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Maximal inspiratory pressure (MIP)

MIP will be measure by Mouth pressure meter (Micro RPM, Micro Medical, Inc., Chatham Maritime, Kent)

Secondary Outcome Measures

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)

Exercise capacity

Exercise capacity by Arm ergometer consists of exercise times, rating of perceived breathlessness (RPB) will examined by Borg scale

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)

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.

Full Information

NCT ID

NCT02752217

First Posted

April 7, 2016

Last Updated

April 25, 2016

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT02752217

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Khon Kaen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inspiratory Muscle Training (IMT)

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Inspiratory Muscle Training

Intervention Description

Inspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Inspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home

Primary Outcome Measure Information:

Title

Change from baseline in Maximal inspiratory pressure (MIP)

Description

MIP will be measure by Mouth pressure meter (Micro RPM, Micro Medical, Inc., Chatham Maritime, Kent)

Time Frame

Baseline and at 8 weeks

Secondary Outcome Measure Information:

Title

Lung capacity

Description

Lung capacity consists of slow vital capacity (SVC), inspiratory capacity (IC). SVC and IC will be measure by a portable computerized spirometer (KoKo spirometer)

Time Frame

Baseline and at 8 weeks

Title

Exercise capacity

Description

Exercise capacity by Arm ergometer consists of exercise times, rating of perceived breathlessness (RPB) will examined by Borg scale

Time Frame

Baseline and at 8 weeks

Title

Chest wall expansion and abdominal expansion

Description

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)

Time Frame

Baseline and at 8 weeks

Title

Blood pressure (BP)

Description

Blood pressure (BP) at home measured by digital bedside monitor. Accordingly follow ACMS recommended. And BP at laboratory test measured by Bedside monitor.

Time Frame

Baseline and at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Phailin Tongdee, Master

Phone

0862957922

pang_haru@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phailin Tongdee, Master

Organizational Affiliation

Faculty of Associated Medical Sciences.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Associated Medical Sciences

City

Na Muang

State/Province

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Phailin Tongdee, Master

Phone

0862957922

pang_haru@hotmail.com

First Name & Middle Initial & Last Name & Degree

Chulee Jones, Docter

Phone

0845164169

joneschulee@gmail.com

First Name & Middle Initial & Last Name & Degree

Phailin Tongdee, Master

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20795924

Citation

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.

Results Reference

result

PubMed Identifier

29604403

Citation

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.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=An+inspiratory+load+enhances+the+antihypertensive++effects+of+home-based+training+with+slow+deep+breathing%3A+a+randomised+trial.

Description

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

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

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