Clinical trial NCT03730935: Respiratory Muscle Endurance Training in Healthy Elderly
Official title: Effects of Respiratory Muscle Endurance Training on Blood Pressure, Exercise Performance and Sleep Quality in Healthy Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Prevalence of hypertension in the elderly is high. Given that hypertension is the leading cause of cardiovascular disease worldwide, safe and efficacious treatment options for this condition are highly desired. Apart from medication, changes in lifestyle are recommended to lower blood pressure, such as an increase in physical exercise. However, whole-body exercise is not feasible for all. Mobility disabilities, for example, increase sharply with age and are already common in middle age. For this population, it is necessary to have alternative, non-invasive interventions with similar effects on blood pressure. One such intervention might be respiratory muscle endurance training (RMET), but the effects on blood pressure are currently unknown.

The primary aim of this project is therefore to investigate the effects of RMET over the course of several weeks on resting blood pressure in healthy elderly. The secondary aim of the project is to evaluate the effects of RMET on uphill exercise performance in healthy active elderly given that elderly experience structural and functional changes of the lungs potentially affecting exercise performance. Finally, since prevalence of subjective sleep complaints is also high in the elderly, the present study will also investigate the effects of RMET on sleep quality.


Eligibility criteria: Inclusion Criteria:

* Age: 55-80 years
* Active (according to World Health Organisation Criteria)
* Systolic blood pressure lower than 140 mmHg and diastolic blood pressure lower than 90 mmHg
* Non-smoking
* Body-Mass-Index (BMI): 18.5-29.9 kg·m-2
* Normal lung function

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 or history of hypertension
* Intake of medications affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system
* Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system

Primary outcomes:
measure: Blood pressure
timeFrame: At baseline and after completion of the study (approximately one month)
Secondary outcomes:
measure: Incremental test
timeFrame: At baseline and after completion of the study (approximately one month)
measure: Endurance capacity test
timeFrame: At baseline and after completion of the study (approximately one month)
measure: Sleep efficiency
timeFrame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
measure: Sleep onset latency
timeFrame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
measure: Fragmentation index
timeFrame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
measure: Oxygen saturation during the night
timeFrame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
measure: Heart rate during the night
timeFrame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
measure: Subjective sleep quality
timeFrame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
state: ZH
Study officials:
References: