NCT03313284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

October 4, 2017

Last Update Submit

August 14, 2018

Conditions

Pre-Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure in mmHg

    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 Outcomes (8)

  • Change in pulse wave velocity in m/s

    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

    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

    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

    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

    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 more secondary outcomes

Study Arms (1)

Study Group

EXPERIMENTAL
Procedure: RMTProcedure: RMT + IHProcedure: Control

Interventions

RMTPROCEDURE

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

Study Group
RMT + IHPROCEDURE

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.

Study Group
ControlPROCEDURE

No intervention

Study Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zurich, Canton of Zurich, 8057, Switzerland

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Christina M. Spengler, Prof.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 18, 2017

Study Start

September 29, 2017

Primary Completion

July 4, 2018

Study Completion

July 4, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)