Clinical trial NCT03313284: Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects?
Official title: Acute Effects of Intermittent Respiratory Muscle Training and Hypoxia on Cardiovascular and Sleep Parameters in Elderly Persons With Prehypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Hypertension
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in blood pressure in mmHg
timeFrame: At 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 intervention
Secondary outcomes:
measure: Change in pulse wave velocity in m/s
timeFrame: At baseline after 25 min of lying in a supine position, and 25, 40 and 55 min after the end of the intervention
measure: Change in cardiac output in L/min
timeFrame: At 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 intervention
measure: Change in total peripheral resistance in dyn x s/cm^5
timeFrame: At 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 intervention
measure: Changes in baroreflex sensitivity in ms/mmHg
timeFrame: At baseline after 15min of lying in a supine position, and 15, 30 and 45 min after the end of the intervention
measure: Change in heart rate variability in ms
timeFrame: At 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 intervention
measure: Change in peripheral oxygenation during sleep in %Saturation
timeFrame: Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)
measure: Change in sleep efficiency defined as the ratio of total sleep time and time in bed
timeFrame: Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)
measure: Change in subjective sleep quality
timeFrame: Within 5 minutes after waking-up following the night after each intervention
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
state: ZH
Study officials:
affiliation: Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
name: Christina M. Spengler, Prof.
role: PRINCIPAL_INVESTIGATOR
References: