Respiratory Muscle Endurance Training in Healthy Elderly

Healthy Clinical Trial

— RETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730935
• Other study ID #: RETE_2018
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: May 24, 2019

Study information

• Verified date: May 2019
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Respiratory muscle endurance training
Respiratory muscle endurance training performed over the duration of 4 weeks

Locations

Country	Name	City	State
Switzerland	Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	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	At baseline and after completion of the study (approximately one month)
Secondary	Incremental test	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.	At baseline and after completion of the study (approximately one month)
Secondary	Endurance capacity test	Change in exercise performance assessed with an endurance capacity test (time to exhaustion, in minutes). The test will be conducted on a motorised treadmill.	At baseline and after completion of the study (approximately one month)
Secondary	Sleep efficiency	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	At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Secondary	Sleep onset latency	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	At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Secondary	Fragmentation index	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	At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Secondary	Oxygen saturation during the night	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	At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Secondary	Heart rate during the night	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	At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Secondary	Subjective sleep quality	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.	At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5