Non-pharmacological Treatment for Essential Isolated Systolic Hypertension in Elderly

NCT02200926 | Completed DMC

• 2 other identifiers: BSangthongchange1me
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Systolic Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Resting blood pressure

  4 months

Secondary Outcomes (7)

• Heart rate

  4 months

• Pulse wave velocity

  4 months

• Exercise pressure response

  4 months

• Heart rate variability

  4 months

• cardiac output

  4 months

Study Arms (3)

Placebo

EXPERIMENTAL

The breathing was performed normally in this groups.

Other: Placebo

Loaded breathing training

EXPERIMENTAL

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.

Other: Loaded breathing training

Unloaded breathing training

EXPERIMENTAL

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.

Other: Unloaded breathing training

Interventions

Loaded breathing training OTHER

7 days/weeks, for 8 weeks

Loaded breathing training

Unloaded breathing training OTHER

7 days/week, for 8 weeks

Unloaded breathing training

Placebo OTHER

7 days/week, for 8 weeks

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of associated medical science, Khon Kaen University

Muang, Changwat Khon Kaen, 40000, Thailand

Location

Related 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. doi: 10.1016/s1836-9553(10)70023-0.

  PMID: 20795924 RESULT

Study Officials

• Benjarat Sangthong, M.Sc.

  Faculty of associated medical science, Khon Kaen University, thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiopulmonay research, Faculty of associated medical science

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: September 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

TH (1)