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Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects?

Acute Effects of Intermittent Respiratory Muscle Training and Hypoxia on Cardiovascular and Sleep Parameters in Elderly Persons With Prehypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03313284
Enrollment
14
Registered
2017-10-18
Start date
2017-09-29
Completion date
2018-07-04
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Hypertension

Brief summary

The prevalence of pre-hypertension and hypertension in the elderly is very high. Apart from medication, physical exercise training is a potential strategy to reduce blood pressure, however, the ability to perform exercise can be limited in the elderly. Hence, alternative non-pharmacological strategies to reduce blood pressure are necessary. Two interventions that have been shown to positively influence blood pressure are respiratory muscle training (RMT) and intermittent hypoxia (IH). Whether a combination of RMT and IH yields even better effects is currently unknown. Therefore, in this study, the effect of a single session of RMT with and without IH on blood pressure and associated cardiovascular parameters will be investigated in elderly subjects with pre-hypertension.

Interventions

PROCEDURERMT

RMT consists of six bouts of 5-min of volitional hyperpnoea . After each RMT bout, participants will breathe room air for 5 minutes.

PROCEDURERMT + IH

RMT and IH consist of six bouts of 5-min of volitional hyperpnoea. After each RMT bout, participants will breathe a hypoxic gas mixture (10.5% O2 ) for 5 minutes.

PROCEDUREControl

No intervention

Sponsors

Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age: 65-80 years * Systolic blood pressure between 130-139 mmHg and diastolic blood pressure lower than 90 mmHg * Non smoking * Normal Body-Mass-Index (BMI): 18.5-24.9 kg·m-2 * Normal Lung Function * Willing to adhere to the general study rules

Exclusion criteria

* Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons * Intake of blood pressure medication * Intake of medications affecting sleep or the performance or the respiratory, cardiovascular or neuromuscular system * Acute or chronic illness other than prehypertension

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressure in mmHgAt baseline after 20 min of lying in a supine position, every 5 minutes during the 60 min intervention, and 20, 35 and 50 min after the end of the interventionBlood pressure before, during, and after each intervention measured with an automated sphygmomanometer

Secondary

MeasureTime frameDescription
Change in cardiac output in L/minAt baseline after 15min of lying in a supine position, every 5 minutes during the 60 min intervention, and 15, 30 and 45 min after the end of the interventionCardiac output before, during, and after each intervention measured with impedance cardiography
Change in total peripheral resistance in dyn x s/cm^5At baseline after 15min of lying in a supine position, every 5 minutes during the 60 min intervention, and 15, 30 and 45 min after the end of the interventionTotal peripheral resistance before, during, and after each intervention measured with impedance cardiography
Changes in baroreflex sensitivity in ms/mmHgAt baseline after 15min of lying in a supine position, and 15, 30 and 45 min after the end of the interventionBaroreflex sensitivity before and after each intervention assessed with photo plethysmography
Change in pulse wave velocity in m/sAt baseline after 25 min of lying in a supine position, and 25, 40 and 55 min after the end of the interventionCarotid-femoral pulse wave velocity before and after each intervention, assessed with a device that simultaneously records (non-invasively) pressure signals from the carotid and femoral arteries
Change in peripheral oxygenation during sleep in %SaturationContinuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)Peripheral oxygenation during sleep measured at home after each intervention with a finger pulse oxymeter
Change in sleep efficiency defined as the ratio of total sleep time and time in bedContinuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)Sleep efficiency measured at home after each intervention with an actigraph
Change in subjective sleep qualityWithin 5 minutes after waking-up following the night after each interventionSleep quality (i.e. How well did you sleep? and How recovered are you?) measured at home after each intervention with a visual analog scale (VAS). The two VAS consists each of a 10cm-horizontal line, with the left end of the lines representing low sleep quality (slept very badly and not recovered at all, respectively) and the right end representing good sleep quality (slept very well and completely recovered, respectively). Participants are asked to draw a vertical line in between the two ends on each of the two VAS.
Change in heart rate variability in msAt baseline after 15min of lying in a supine position, every 5 minutes during the 60 min intervention, and 15, 30 and 45 min after the end of the interventionHeart rate variability measured before, during and after each intervention with impedance cardiography

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026