Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05759598 |
| Other study ID # |
01C020 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2021 |
| Est. completion date |
June 8, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Istituto Auxologico Italiano |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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:
1. BMI standard deviation score (SDS)>2 for patients < 18 years and BMI>35 for patients
aged>18 years;
2. absence of structured physical activity programs (regular activity for more than 120
minutes/week) during the 6 months preceding the study;
3. 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.
