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Non-pharmacological Treatment for Essential Isolated Systolic Hypertension in Elderly

Primary Purpose

Systolic Essential Hypertension

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Loaded breathing training
Unloaded breathing training
Placebo
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systolic Essential Hypertension

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Essential isolated systolic hypertension (stage I- II, based on recommendations of JNC-VII)
  • Good communication

Exclusion Criteria:

  • Essential hypertension stage III or secondary hypertension
  • History of respiratory disease, heart disease, renal disease, blindness, deafness and cerebrovascular disease.

Sites / Locations

  • Faculty of associated medical science, Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Placebo

Loaded breathing training

Unloaded breathing training

Arm Description

The breathing was performed normally in this groups.

subjects will trained to inspire deeply against the resistance setting by using BreathMAX® at the loaded of 18 cmH2O with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.

subjects will trained to inspire deeply (no resistance) with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.

Outcomes

Primary Outcome Measures

Resting blood pressure

Secondary Outcome Measures

Heart rate
Pulse wave velocity
Exercise pressure response
Heart rate variability
cardiac output
Flow-mediated dilatation of brachial artery
Forearm limb blood flow

Full Information

First Posted
July 24, 2014
Last Updated
September 8, 2016
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT02200926
Brief Title
Non-pharmacological Treatment for Essential Isolated Systolic Hypertension in Elderly
Official Title
Effects of Slow Loaded and Unloaded Breathing Training
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
September 2016 (Actual)

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
The previous studies used the slow loaded breathing device for breathing training (Jones et al., 2010). It has been shown that slow loaded breathing training can reduce resting blood pressure and heart rate in essential hypertensive patients. However, this has not been studied in elderly with essential isolated systolic hypertensive patients. Not only highest prevalence of hypertension in Thailand was found in elderly but also physiological changes in the elderly are cause of interest in this special population. It has many advantages to use a slow loaded breathing training in elderly people. Firstly, it is low technology and easily implemented at home. Secondly, it can be practiced almost anytime and anywhere. Thirdly, the orthopedic complications of slow loaded breathing training are minimal. Finally, slow loaded breathing training may be enhancing cardiopulmonary function and other fitness traits, but it out of scope of this study. Moreover, slow loaded breathing exercise by itself should not result in any metabolic adaptation of skeletal muscles, such as the forearm, which had not been trained. If slow loaded breathing training modified some central component of the pressor reflex pathway in a way that single muscle training might work, as suggested above, then loaded breathing training would have a modulating effect on the pressor responses of muscles that had not been trained. We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax on blood pressure at rest and exercise in elderly with essential isolated systolic hypertension and also investigate the autonomic function and others that may be involved with the changed blood pressure in elderly with essential isolated systolic hypertension. We hypothesized that slow loaded and unloaded breathing training could reduce resting and exercising blood pressure in elderly with essential isolated systolic hypertension.
Detailed Description
All subjects will be trained for blood pressure and heart rate measurement at home by using a digital arm blood pressure monitoring for 2 weeks control periods before start breathing training. After 2 weeks, subjects in both breathing training groups will trained to inspire deeply against the resistance setting by using Breathmax at the loaded of 18 centimeter of water (cmH2O) and 0 cmH2O (no resistance) with breathing frequency control at 6 breaths/minute in loaded breathing (LB) and unloaded breathing (ULB) group, respectively. They will rest for 5 seconds after every 6 deep breathing. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The paced breathing will be practice using metronome at the laboratory until the subjects can do independently without metronome. The breathing was performed normally in control groups (C). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks. After 8 weeks of breathing training, the sustainability of breathing training effect will be assessed. Subjects in both breathing training groups (LB and ULB) will be stop breathing training with Breathmax and change to breathing normally. In contrast with the subjects in control group, they will be divided to 2 subgroups. The first subgroup performed loaded breathing training at the loaded of 18 cmH2O. The another subgroup performed unloaded breathing training at the loaded of 0 cmH2O. Breathing frequency will be control at 6 breaths/minute in both subgroups. The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks. Data collection will be carried out for 4 times: (1) before control, (2) before training, (3) after training and (4) after stop training. All measurement will be done in the cardiovascular laboratory room, department of physical therapy, faculty of associated medical sciences. In addition, self measurement of blood pressure and heart rate will be conducted at home every morning after getting up at the same time throughout the study (from week 0 to 18).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
The breathing was performed normally in this groups.
Arm Title
Loaded breathing training
Arm Type
Experimental
Arm Description
subjects will trained to inspire deeply against the resistance setting by using BreathMAX® at the loaded of 18 cmH2O with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
Arm Title
Unloaded breathing training
Arm Type
Experimental
Arm Description
subjects will trained to inspire deeply (no resistance) with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Loaded breathing training
Intervention Description
7 days/weeks, for 8 weeks
Intervention Type
Other
Intervention Name(s)
Unloaded breathing training
Intervention Description
7 days/week, for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
7 days/week, for 8 weeks
Primary Outcome Measure Information:
Title
Resting blood pressure
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
4 months
Title
Pulse wave velocity
Time Frame
4 months
Title
Exercise pressure response
Time Frame
4 months
Title
Heart rate variability
Time Frame
4 months
Title
cardiac output
Time Frame
4 months
Title
Flow-mediated dilatation of brachial artery
Time Frame
4 months
Title
Forearm limb blood flow
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Essential isolated systolic hypertension (stage I- II, based on recommendations of JNC-VII) Good communication Exclusion Criteria: Essential hypertension stage III or secondary hypertension History of respiratory disease, heart disease, renal disease, blindness, deafness and cerebrovascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjarat Sangthong, M.Sc.
Organizational Affiliation
Faculty of associated medical science, Khon Kaen University, thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of associated medical science, Khon Kaen University
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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

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Non-pharmacological Treatment for Essential Isolated Systolic Hypertension in Elderly

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