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Pre-HypertensionNCT03313284

Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects?

A study testing RMT and RMT + IH in people with Pre-Hypertension, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Pre-Hypertension
What is being tested?
RMT and RMT + IH
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSwitzerland
Study dates
29 Sep 2017to 4 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Zurich, Canton of Zurich, 8057

Other trials in Switzerland

About this study

Official title: 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.

Being tested
RMT, RMT + IH, Control
Medical subject headings
Prehypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RMTProcedure or surgery

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

  • RMT + IHProcedure or surgery

    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.

  • ControlProcedure or surgery

    No intervention

Study groups in NCT03313284
Study groupRoleWhat they receive
Study GroupExperimentalNot described
Receives: Procedure: RMT; Procedure: RMT + IH; Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood pressure in mmHg

    Blood pressure before, during, and after each intervention measured with an automated sphygmomanometer

    Measured: 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 (8)

  1. 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

    Measured: At baseline after 25 min of lying in a supine position, and 25, 40 and 55 min after the end of the intervention

  2. Change in cardiac output in L/min

    Cardiac output before, during, and after each intervention measured with impedance cardiography

    Measured: 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

  3. Change in total peripheral resistance in dyn x s/cm^5

    Total peripheral resistance before, during, and after each intervention measured with impedance cardiography

    Measured: 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

  4. Changes in baroreflex sensitivity in ms/mmHg

    Baroreflex sensitivity before and after each intervention assessed with photo plethysmography

    Measured: At baseline after 15min of lying in a supine position, and 15, 30 and 45 min after the end of the intervention

  5. Change in heart rate variability in ms

    Heart rate variability measured before, during and after each intervention with impedance cardiography

    Measured: 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

  6. Change in peripheral oxygenation during sleep in %Saturation

    Peripheral oxygenation during sleep measured at home after each intervention with a finger pulse oxymeter

    Measured: Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)

  7. 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

    Measured: Continuously during the night following each intervention, from time to bed until wake up time in the morning (i.e. on average approximately 8hours)

  8. 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.

    Measured: Within 5 minutes after waking-up following the night after each intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2017
  2. Study start29 Sep 2017
  3. Primary completion4 Jul 2018
  4. Study completion4 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03313284
Sponsor's protocol ID
REHYPE_2017
Status last verified
Aug 2018
First submitted
4 Oct 2017
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing RMT and RMT + IH in people with Pre-Hypertension, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03313284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.

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