HealthyRETENCT03730935
Respiratory Muscle Endurance Training in Healthy Elderly
A study testing Respiratory muscle endurance training in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Respiratory muscle endurance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Dec 2018to 24 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Zurich, Canton of Zurich, 8057
About this study
Official title: Effects of Respiratory Muscle Endurance Training on Blood Pressure, Exercise Performance and Sleep Quality 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.
- Conditions
- Healthy
- Being tested
- Respiratory muscle endurance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle endurance trainingDevice
Respiratory muscle endurance training performed over the duration of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Device: Respiratory muscle endurance training |
| Sham | Sham comparator | 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. Receives: Device: Respiratory muscle endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and after completion of the study (approximately one month)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start7 Dec 2018
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730935
- Sponsor's protocol ID
- RETE_2018
- Acronym
- RETE
- Status last verified
- May 2019
- First submitted
- 31 Oct 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Endurance Training on Blood Pressure, Exercise Performance and Sleep Quality in Healthy Elderly
- ClinicalTrials.gov ID
- NCT03730935
- Acronym / sponsor ID
- RETE / RETE_2018
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Respiratory muscle endurance trainingRespiratory 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). |
| Sham | Sham comparator | Device: Respiratory muscle endurance trainingSham 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory muscle endurance trainingRespiratory muscle endurance training performed over the duration of 4 weeks | Device | Intervention, Sham |
Primary outcome
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
8 secondary outcomes
Incremental test
Time frame: At baseline and after completion of the study (approximately one month)
Endurance capacity test
Time frame: At baseline and after completion of the study (approximately one month)
Sleep efficiency
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Sleep onset latency
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Fragmentation index
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
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
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Subjective sleep quality
Time frame: At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle endurance training in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: At baseline and after completion of the study (approximately one month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.