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Clinical Trials/NCT03730935
NCT03730935
Completed
Not Applicable

Effects of Respiratory Muscle Endurance Training on Blood Pressure, Exercise Performance and Sleep Quality in Healthy Elderly

Swiss Federal Institute of Technology1 site in 1 country24 target enrollmentDecember 7, 2018
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Swiss Federal Institute of Technology
Enrollment
24
Locations
1
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 7, 2018
End Date
May 24, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Blood pressure

Time Frame: At baseline and after completion of the study (approximately one month)

Change in systolic and diastolic blood pressures (in mmHg) between baseline and after one month of training. Measurements will be done in triplicate after at least 10 minutes of quiet lying on a stretcher

Secondary Outcomes

  • Incremental test(At baseline and after completion of the study (approximately one month))
  • Endurance capacity test(At baseline and after completion of the study (approximately one month))
  • Sleep efficiency(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
  • Heart rate during the night(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
  • Sleep onset latency(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
  • Fragmentation index(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
  • Oxygen saturation during the night(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
  • Subjective sleep quality(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)

Study Sites (1)

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