An interventional study of Respiratory muscle endurance training in Healthy, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Basic science
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.
Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Respiratory muscle endurance training (30 minutes of volitional hyperpnoea at a target ventilation of 60-70% of the individual maximal voluntary ventilation for 5 days per week for 4 weeks).
Device: Respiratory muscle endurance training
Sham training will be performed 5 times a week for 4 weeks using a mock asthma inhaler filled with 5.5 mg lactose powder. Subjects will be instructed to inhale the powder according to inhaler instructions and to then perform one full inspiration to total lung capacity using custom-made, low resistance tubing, which elicits minimal resistance to breathing.
Device: Respiratory muscle endurance training
Respiratory muscle endurance training performed over the duration of 4 weeks
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
Time frame: At baseline and after completion of the study (approximately one month)
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.
Time frame: At baseline and after completion of the study (approximately one month)
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.
Time frame: At baseline and after completion of the study (approximately one month)
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
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
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
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
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
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
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
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
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
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
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.
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Swiss Federal Institute of Technology