Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects?

NCT ID: NCT03313284

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2018-07-04

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.

Conditions

Pre-Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

Group Type: EXPERIMENTAL

RMT

Intervention Type: PROCEDURE

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

RMT + IH

Intervention Type: PROCEDURE

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.

Control

Intervention Type: PROCEDURE

No intervention

Interventions

RMT

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

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.

Intervention Type: PROCEDURE

Control

No intervention

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina M. Spengler, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

REHYPE_2017

Identifier Type: -

Identifier Source: org_study_id