ObesityALRESPGHOBNCT05759598
Effect of Respiratory Training Protocols on GH Secretion in Obesity (ALRESPGHOB)
A study testing Rehabilitation protocol + guided spontaneous breathing exercises and Rehabilitation protocol + specific respiratory muscle training program in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The study's primary objective is to evaluate the acute and chronic (3 weeks) effects of two respiratory training protocols in obese adolescents (performed during a period of hospitalization for a body weight reduction program), with different characteristics and mechanisms of action, on GH and IGF-I secretion. Read more about this study
- Who is it for?
- Ages 14 to 30 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- Rehabilitation protocol + guided spontaneous breathing exercises and Rehabilitation protocol + specific respiratory muscle training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2021to 8 Jun 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 14 to 30 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI standard deviation score (SDS) > 2 for subjects aged < 18 years and BMI > 35 for patients aged >18 years;
- absence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
Who cannot join
- age < 14 years and > 30 years;
- presence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- presence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano, Site Piancavallo
Oggebbio, Verbania, 28824
About this study
Official title: Effect of Respiratory Training Protocols on GH Secretion in the Obese Patient
The study's primary objective is to evaluate the acute and chronic (3 weeks) effects of two respiratory training protocols in obese adolescents (performed during a period of hospitalization for a body weight reduction program), with different characteristics and mechanisms of action, on GH and IGF-I secretion. The definition of the protocols is based on what has been observed by recent studies conducted on healthy people (Wuthrich et al., 2015; Schaer et al., 2018) and on patient populations in which respiratory dysfunction is a primary or secondary component of the pathology (Calcaterra et al., 2014; Pomidori et al., 2009). All planned interventions are safe and are adapted to the obese patient.
Project objectives are:
- assessment of GH-IGF-I responses (baseline), during the first training session of the respiratory muscles conducted in the first days of hospitalization of the patients in the clinic
- assessment of GH-IGF-I responses (post), during the last training session of the respiratory muscles conducted at the end of the three weeks of each training session
Read the detailed description
Materials and methods:
Subjects The study provides for the recruitment of 20 obese boys/young adults aged between 14 and 30 years old hospitalized at the Division of Auxology and the Division of Metabolic Diseases, Istituto Auxologico Italiano, S. Giuseppe Hospital, Piancavallo (VB).
Criteria for inclusion in the study group are:
- BMI standard deviation score (SDS)>2 for patients < 18 years and BMI>35 for patients aged>18 years;
- absence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
Materials and methods:
During the first respiratory training session (basal) and at the end of the three weeks of hospitalization (post) for an integrated metabolic rehabilitation program at the Division of Auxology (patients aged < 18 years) and Division and Metabolic Diseases (adults) a blood sample is taken from each subject to determine the circulating levels of GH (total and isoforms 20 kDa and 22kDa) and cortisol in pre-training conditions and at times 0 ' (immediately at the end), +15', +30' and +60' (IGF-I levels are determined only in pre-workout conditions and immediately at the end). Blood samples taken after training are carried out by needle cannula during a saline infusion, to reduce the number of venipunctures. Lactate levels are determined by earlobe puncture in basal conditions, immediately at the end of the training session, and repeated every 2 minutes, until the peak value is reached.
In baseline conditions and at the end of the 3 weeks of respiratory training, body composition is evaluated (by impedance analysis), the maximum force developed during voluntary isometric contraction of the extensor and flexor muscles of the lower limb (by dynamometer), and spirometry is performed for the assessment of maximal lung capacity.
Respiratory muscle training protocol:
The recruited subjects are randomly divided into two homogeneous groups in terms of the number and basic characteristics of the subjects. A control group (CTRL) carries out the standard integrated metabolic rehabilitation protocol with the addition of guided spontaneous breathing exercises lasting about 20 minutes per session for 12 sessions.
An experimental group (RMT) carries out, in addition to the standard integrated metabolic rehabilitation protocol, a specific respiratory muscle training program according to the protocol recently proposed by Spengler et al. (Wuthrich et al., 2015; Schaer et al., 2018), adapted according to the baseline characteristics of the respiratory function of the subjects. The protocol includes 12 interval breathing training sessions, divided into 3 weeks (4 sessions/week) each lasting a total of about 12 minutes. Each respiratory training session includes 6 1-minute "sprint" breathing intervals followed by 1 minute of recovery. During the sprint intervals, the subjects breathe through a dedicated SpiroTiger instrument (Idiag AG, Fehraltorf, Switzerland) with the addition of a resistance (Schaer et al., 2018) which allows normocapnic hyperpnea against resistance. Subjects are asked to breathe at a respiratory rate of 25-30 breaths/minute with a constant tidal volume corresponding to approximately 60% of forced vital capacity. The target frequency is adjusted on an individual basis and is defined during the initial familiarization trials.
- Conditions
- Obesity
- Being tested
- Rehabilitation protocol + guided spontaneous breathing exercises, Rehabilitation protocol + specific respiratory muscle training program
- Keywords
- Growth hormone, Insulin-like growth factor, Training of respiratory muscles
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation protocol + guided spontaneous breathing exercisesOther
Standard integrated metabolic rehabilitation protocol + guided spontaneous breathing exercises
Rehabilitation protocol + specific respiratory muscle training programOther
Standard integrated metabolic rehabilitation protocol + specific respiratory muscle training program according to the protocol recently proposed by Spengler et al. (Wuthrich et al., 2015; Schaer et al., 2018), adapted according to the baseline characteristics of the respiratory function of the subjects
| Study group | Role | What they receive |
|---|---|---|
| Control group (CTRL) | Other | Not described Receives: Other: Rehabilitation protocol + guided spontaneous breathing exercises |
| Experimental group (RMT) | Experimental | Not described Receives: Other: Rehabilitation protocol + specific respiratory muscle training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone (GH)
Change in plasma concentration of growth hormone
Measured: Baseline, 0, 15, 30 and 45 minutes after Intervention and 3 weeks after intervention
Insulin-like growth factor (IGF-I)
Change in plasma concentration of insulin-like growth factor
Measured: Baseline and 0 minutes after Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start14 Oct 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Why it stopped: Lack of hormonal responses (GH) in response to the respiratory training protocols in the three subjects tested.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759598
- Sponsor's protocol ID
- 01C020
- Acronym
- ALRESPGHOB
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Training Protocols on GH Secretion in the Obese Patient
- ClinicalTrials.gov ID
- NCT05759598
- Acronym / sponsor ID
- ALRESPGHOB / 01C020
- Conditions
- Obesity
- Keywords
- Growth hormone, Insulin-like growth factor, Training of respiratory muscles
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of hormonal responses (GH) in response to the respiratory training protocols in the three subjects tested.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 8 Mar 2023 (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.
The study's primary objective is to evaluate the acute and chronic (3 weeks) effects of two respiratory training protocols in obese adolescents (performed during a period of hospitalization for a body weight reduction program), with different characteristics and mechanisms of action, on GH and IGF-I secretion. The definition of the protocols is based on what has been observed by recent studies conducted on healthy people (Wuthrich et al., 2015; Schaer et al., 2018) and on patient populations in which respiratory dysfunction is a primary or secondary component of the pathology (Calcaterra et al., 2014; Pomidori et al., 2009). All planned interventions are safe and are adapted to the obese patient.
Project objectives are:
- assessment of GH-IGF-I responses (baseline), during the first training session of the respiratory muscles conducted in the first days of hospitalization of the patients in the clinic
- assessment of GH-IGF-I responses (post), during the last training session of the respiratory muscles conducted at the end of the three weeks of each training session
Detailed description
Materials and methods:
Subjects The study provides for the recruitment of 20 obese boys/young adults aged between 14 and 30 years old hospitalized at the Division of Auxology and the Division of Metabolic Diseases, Istituto Auxologico Italiano, S. Giuseppe Hospital, Piancavallo (VB).
Criteria for inclusion in the study group are:
- BMI standard deviation score (SDS)>2 for patients < 18 years and BMI>35 for patients aged>18 years;
- absence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
Materials and methods:
During the first respiratory training session (basal) and at the end of the three weeks of hospitalization (post) for an integrated metabolic rehabilitation program at the Division of Auxology (patients aged < 18 years) and Division and Metabolic Diseases (adults) a blood sample is taken from each subject to determine the circulating levels of GH (total and isoforms 20 kDa and 22kDa) and cortisol in pre-training conditions and at times 0 ' (immediately at the end), +15', +30' and +60' (IGF-I levels are determined only in pre-workout conditions and immediately at the end). Blood samples taken after training are carried out by needle cannula during a saline infusion, to reduce the number of venipunctures. Lactate levels are determined by earlobe puncture in basal conditions, immediately at the end of the training session, and repeated every 2 minutes, until the peak value is reached.
In baseline conditions and at the end of the 3 weeks of respiratory training, body composition is evaluated (by impedance analysis), the maximum force developed during voluntary isometric contraction of the extensor and flexor muscles of the lower limb (by dynamometer), and spirometry is performed for the assessment of maximal lung capacity.
Respiratory muscle training protocol:
The recruited subjects are randomly divided into two homogeneous groups in terms of the number and basic characteristics of the subjects. A control group (CTRL) carries out the standard integrated metabolic rehabilitation protocol with the addition of guided spontaneous breathing exercises lasting about 20 minutes per session for 12 sessions.
An experimental group (RMT) carries out, in addition to the standard integrated metabolic rehabilitation protocol, a specific respiratory muscle training program according to the protocol recently proposed by Spengler et al. (Wuthrich et al., 2015; Schaer et al., 2018), adapted according to the baseline characteristics of the respiratory function of the subjects. The protocol includes 12 interval breathing training sessions, divided into 3 weeks (4 sessions/week) each lasting a total of about 12 minutes. Each respiratory training session includes 6 1-minute "sprint" breathing intervals followed by 1 minute of recovery. During the sprint intervals, the subjects breathe through a dedicated SpiroTiger instrument (Idiag AG, Fehraltorf, Switzerland) with the addition of a resistance (Schaer et al., 2018) which allows normocapnic hyperpnea against resistance. Subjects are asked to breathe at a respiratory rate of 25-30 breaths/minute with a constant tidal volume corresponding to approximately 60% of forced vital capacity. The target frequency is adjusted on an individual basis and is defined during the initial familiarization trials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (CTRL) | Other | Other: Rehabilitation protocol + guided spontaneous breathing exercises |
| Experimental group (RMT) | Experimental | Other: Rehabilitation protocol + specific respiratory muscle training program |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- BMI standard deviation score (SDS) > 2 for subjects aged < 18 years and BMI > 35 for patients aged >18 years;
- absence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
Key exclusion criteria (3 listed)
- age < 14 years and > 30 years;
- presence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- presence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
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 |
|---|---|---|
| Rehabilitation protocol + guided spontaneous breathing exercisesStandard integrated metabolic rehabilitation protocol + guided spontaneous breathing exercises | Other | Control group (CTRL) |
| Rehabilitation protocol + specific respiratory muscle training programStandard integrated metabolic rehabilitation protocol + specific respiratory muscle training program according to the protocol recently proposed by Spengler et al. (Wuthrich et al., 2015; Schaer et al., 2018), adapted according to the baseline characteristics of the respiratory function of the subjects | Other | Experimental group (RMT) |
Primary outcome
Growth hormone (GH)
Time frame: Baseline, 0, 15, 30 and 45 minutes after Intervention and 3 weeks after intervention
Change in plasma concentration of growth hormone
Insulin-like growth factor (IGF-I)
Time frame: Baseline and 0 minutes after Intervention
Change in plasma concentration of insulin-like growth factor
Results and safety
The study was stopped early (reason given: Lack of hormonal responses (GH) in response to the respiratory training protocols in the three subjects tested.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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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 Rehabilitation protocol + guided spontaneous breathing exercises and Rehabilitation protocol + specific respiratory muscle training program in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 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 Italy. 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 was stopped early (reason given: Lack of hormonal responses (GH) in response to the respiratory training protocols in the three subjects tested.). Results are not available in the source record.
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?
Growth hormone (GH) (time frame: Baseline, 0, 15, 30 and 45 minutes after Intervention and 3 weeks after intervention). 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 9 Mar 2023.