Healthy AgingNCT04520763
Effects of Respiratory Muscle Exercises on Glucose Tolerance in Healthy Adults
A study testing 5min respiratory muscle exercises and 15min respiratory muscle exercises in people with Healthy Aging and Healthy Diet, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
To evaluate the acute effects of respiratory muscle exercises vs. a control intervention on blood glucose kinetics in healthy adults after an oral glucose tolerance test. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Healthy Diet
- What is being tested?
- 5min respiratory muscle exercises and 15min respiratory muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Aug 2020to 21 Apr 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Healthy
- Non-smoking
- Body mass index (BMI): 18.5 - 29.9 kg∙m-2
- Normal lung function
- Willing to adhere to study rules
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
- Intake of medications affecting metabolism, the cardiovascular or the respiratory system, or sleep
- Acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
- Pregnancy, breastfeeding, or intention to become pregnant during the study
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
To evaluate the acute effects of respiratory muscle exercises vs. a control intervention on blood glucose kinetics in healthy adults after an oral glucose tolerance test.
- Conditions
- Healthy Aging, Healthy Diet
- Being tested
- 5min respiratory muscle exercises, 15min respiratory muscle exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5min respiratory muscle exercisesOther
5 min of hyperpnea at a target intensity of 60-80% MVV 15-30min after ingestion of 75g of glucose
15min respiratory muscle exercisesOther
5 min of hyperpnea at a target intensity of 60-70% MVV 15-30min after ingestion of 75g of glucose
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Muscle Exercises | Experimental | Two respiratory muscle exercises Receives: Other: 5min respiratory muscle exercises; Other: 15min respiratory muscle exercises |
| Control | No intervention | The control intervention consists of quiet sitting for 15 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak blood glucose concentration
Peak blood glucose concentration will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).
Measured: throughout the study, an expected average of 2 weeks per participant
area under the glucose-time curve
Area under the glucose-time curve will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).
Measured: throughout the study, an expected average of 2 weeks per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start20 Aug 2020
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study consists of four visits to the laboratory, each separated by at least 24 hours and each lasting approximately 2.5h. Total duration for each participant is approximately 2 weeks. The study is conducted in 40 healthy adults (≥ 18 years). The study is a randomized, controlled cross-over trial. We chose a cross-over design in order to test the effects of different respiratory exercises compared to a control intervention in order to minimize variability since each subject serves as his/her own control. Due to the nature of the intervention (respiratory muscle exercises), it is not possible to blind participants to the interventions.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christin M. Spengler, Prof., Principal investigator, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520763
- Sponsor's protocol ID
- HOGTT_2020
- Status last verified
- Mar 2023
- First submitted
- 17 Aug 2020
- Last updated
- 17 Mar 2023
- 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 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Exercises on Glucose Tolerance in Healthy Adults
- ClinicalTrials.gov ID
- NCT04520763
- Acronym / sponsor ID
- HOGTT_2020
- Conditions
- Healthy Aging, Healthy Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 20 Aug 2020 (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.
To evaluate the acute effects of respiratory muscle exercises vs. a control intervention on blood glucose kinetics in healthy adults after an oral glucose tolerance test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study consists of four visits to the laboratory, each separated by at least 24 hours and each lasting approximately 2.5h. Total duration for each participant is approximately 2 weeks. The study is conducted in 40 healthy adults (≥ 18 years). The study is a randomized, controlled cross-over trial. We chose a cross-over design in order to test the effects of different respiratory exercises compared to a control intervention in order to minimize variability since each subject serves as his/her own control. Due to the nature of the intervention (respiratory muscle exercises), it is not possible to blind participants to the interventions.
| Arm | Type | Receives |
|---|---|---|
| Respiratory Muscle Exercises | Experimental | Other: 5min respiratory muscle exercises, Other: 15min respiratory muscle exercisesTwo respiratory muscle exercises |
| Control | No intervention | –The control intervention consists of quiet sitting for 15 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Healthy
- Non-smoking
- Body mass index (BMI): 18.5 - 29.9 kg∙m-2
- Normal lung function
Key exclusion criteria (6 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
- Intake of medications affecting metabolism, the cardiovascular or the respiratory system, or sleep
- Acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
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 |
|---|---|---|
| 5min respiratory muscle exercises5 min of hyperpnea at a target intensity of 60-80% MVV 15-30min after ingestion of 75g of glucose | Other | Respiratory Muscle Exercises |
| 15min respiratory muscle exercises5 min of hyperpnea at a target intensity of 60-70% MVV 15-30min after ingestion of 75g of glucose | Other | Respiratory Muscle Exercises |
Primary outcome
Peak blood glucose concentration
Time frame: throughout the study, an expected average of 2 weeks per participant
Peak blood glucose concentration will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).
area under the glucose-time curve
Time frame: throughout the study, an expected average of 2 weeks per participant
Area under the glucose-time curve will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).
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 17 Mar 2023.
Related trials for Healthy Aging
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
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.
Christin M. Spengler, Prof. principal investigator
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5min respiratory muscle exercises and 15min respiratory muscle exercises in people with Healthy Aging and Healthy Diet, 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 6 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 17 Mar 2023. 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. 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?
Peak blood glucose concentration (time frame: throughout the study, an expected average of 2 weeks per participant). The study lists 2 primary outcomes in all. 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 17 Mar 2023.