Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects?
Primary Purpose
Pre-Hypertension
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
RMT
RMT + IH
Control
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Outcomes
Primary Outcome Measures
Change in blood pressure in mmHg
Blood pressure before, during, and after each intervention measured with an automated sphygmomanometer
Secondary Outcome Measures
Change in pulse wave velocity in m/s
Carotid-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 cardiac output in L/min
Cardiac output before, during, and after each intervention measured with impedance cardiography
Change in total peripheral resistance in dyn x s/cm^5
Total peripheral resistance before, during, and after each intervention measured with impedance cardiography
Changes in baroreflex sensitivity in ms/mmHg
Baroreflex sensitivity before and after each intervention assessed with photo plethysmography
Change in heart rate variability in ms
Heart rate variability measured before, during and after each intervention with impedance cardiography
Change in peripheral oxygenation during sleep in %Saturation
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 bed
Sleep efficiency measured at home after each intervention with an actigraph
Change in subjective sleep quality
Sleep 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.
Full Information
NCT ID
NCT03313284
First Posted
October 4, 2017
Last Updated
August 14, 2018
Sponsor
Swiss Federal Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03313284
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
July 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
RMT
Intervention Description
RMT consists of six bouts of 5-min of volitional hyperpnoea . After each RMT bout, participants will breathe room air for 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
RMT + IH
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Change in blood pressure in mmHg
Description
Blood pressure before, during, and after each intervention measured with an automated sphygmomanometer
Time Frame
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 Outcome Measure Information:
Title
Change in pulse wave velocity in m/s
Description
Carotid-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
Time Frame
At baseline after 25 min of lying in a supine position, and 25, 40 and 55 min after the end of the intervention
Title
Change in cardiac output in L/min
Description
Cardiac output before, during, and after each intervention measured with impedance cardiography
Time Frame
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
Title
Change in total peripheral resistance in dyn x s/cm^5
Description
Total peripheral resistance before, during, and after each intervention measured with impedance cardiography
Time Frame
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
Title
Changes in baroreflex sensitivity in ms/mmHg
Description
Baroreflex sensitivity before and after each intervention assessed with photo plethysmography
Time Frame
At baseline after 15min of lying in a supine position, and 15, 30 and 45 min after the end of the intervention
Title
Change in heart rate variability in ms
Description
Heart rate variability measured before, during and after each intervention with impedance cardiography
Time Frame
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
Title
Change in peripheral oxygenation during sleep in %Saturation
Description
Peripheral oxygenation during sleep measured at home after each intervention with a finger pulse oxymeter
Time Frame
Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)
Title
Change in sleep efficiency defined as the ratio of total sleep time and time in bed
Description
Sleep efficiency measured at home after each intervention with an actigraph
Time Frame
Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)
Title
Change in subjective sleep quality
Description
Sleep 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.
Time Frame
Within 5 minutes after waking-up following the night after each intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M. Spengler, Prof.
Organizational Affiliation
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8057
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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