Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects?

August 14, 2018 updated by: Swiss Federal Institute of Technology

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8057
        • Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Study Group
Procedure: RMT
RMT consists of six bouts of 5-min of volitional hyperpnoea . After each RMT bout, participants will breathe room air for 5 minutes.
Procedure: RMT + 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.
Procedure: Control
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in blood pressure in mmHg
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
Blood pressure before, during, and after each intervention measured with an automated sphygmomanometer
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pulse wave velocity in m/s
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
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
At baseline after 25 min of lying in a supine position, and 25, 40 and 55 min after the end of the intervention
Change in cardiac output in L/min
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
Cardiac output before, during, and after each intervention measured with impedance cardiography
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
Change in total peripheral resistance in dyn x s/cm^5
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
Total peripheral resistance before, during, and after each intervention measured with impedance cardiography
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
Changes in baroreflex sensitivity in ms/mmHg
Time Frame: At baseline after 15min of lying in a supine position, and 15, 30 and 45 min after the end of the intervention
Baroreflex sensitivity before and after each intervention assessed with photo plethysmography
At baseline after 15min of lying in a supine position, and 15, 30 and 45 min after the end of the intervention
Change in heart rate variability in ms
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
Heart rate variability measured before, during and after each intervention with impedance cardiography
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
Change in peripheral oxygenation during sleep in %Saturation
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)
Peripheral oxygenation during sleep measured at home after each intervention with a finger pulse oxymeter
Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)
Change in sleep efficiency defined as the ratio of total sleep time and time in bed
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)
Sleep efficiency measured at home after each intervention with an actigraph
Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)
Change in subjective sleep quality
Time Frame: Within 5 minutes after waking-up following the night after each intervention
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.
Within 5 minutes after waking-up following the night after each intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REHYPE_2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pre-Hypertension

Clinical Trials on RMT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings