Skip to main content
OpenTrials
Completed

NCT Number: NCT03730935

Respiratory Muscle Endurance Training in Healthy Elderly

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zurich, Canton of Zurich, 8057, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory muscle endurance training

Device

Respiratory muscle endurance training performed over the duration of 4 weeks

Primary outcomes

  1. 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

  1. Incremental test

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

    Change in exercise performance assessed with an incremental test to exhaustion (maximal oxygen consumption in ml· min-1· kg-1). The test will be conducted on a motorised treadmill.

  2. Endurance capacity test

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

    Change in exercise performance assessed with an endurance capacity test (time to exhaustion, in minutes). The test will be conducted on a motorised treadmill.

  3. Sleep efficiency

    Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

    Change in sleep efficiency assessed with an actigraph device measuring sleep efficiency (in %), . Measurements will be done during the nights between the two baseline visits and between the two post visits

  4. Sleep onset latency

    Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

    Change in sleep onset latency assessed objectively with an actigraph device measuring sleep onset latency (in min). Measurements will be done during the nights between the two baseline visits and between the two post visits

  5. Fragmentation index

    Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

    Change in fragmentation index assessed objectively with an actigraph device measuring fragmentation index (unitless). Measurements will be done during the nights between the two baseline visits and between the two post visits

  6. Oxygen saturation during the night

    Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

    Change in oxygen saturation assessed objectively with a wrist-worn pulse oximeter measuring oxygen saturation (in %). Measurements will be done during the nights between the two baseline visits and between the two post visits

  7. Heart rate during the night

    Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

    Change in heart rate assessed objectively with a wrist-worn pulse oximeter measuring heart rate (in 1·min-1). Measurements will be done during the nights between the two baseline visits and between the two post visits

  8. Subjective sleep quality

    Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5

    Change in subjective 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.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

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

Acronym: RETE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2018
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.