Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000131550
Ethics application status
Approved
Date submitted
5/10/2023
Date registered
13/02/2024
Date last updated
13/02/2024
Date data sharing statement initially provided
13/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the cardiorespiratory and anti-inflammatory effects of hypoxia-hyperoxia exposure sessions in elderly adults. A randomised controlled trial
Scientific title
Investigating the influence of a 6-week hypoxia-hyperoxia exposure protocol in elderly adults on cardiorespiratory condition, blood pressure, arterial oxygen saturation and inflammatory biomarkers. A randomised controlled trial.
Secondary ID [1] 310737 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly adults 331685 0
Condition category
Condition code
Cardiovascular 328419 328419 0 0
Normal development and function of the cardiovascular system
Inflammatory and Immune System 328420 328420 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Experimental Group (EG) will undergo a 6-week intervention, involving alternate sessions of Intermittent Hypoxic Hyperoxic Exposure (IHHE) using the Energy/iAltitude® device (iAltitude Training S.L., Fuenlabrada, Madrid, Spain). Participants will breathe air with an oxygen concentration (FiO2) between 10-14% for 1-5 minutes, followed by 1-3 minutes of hyperoxia (FiO2 30-40%), totaling 4-8 cycles. The number of cycles will be based on the individual's acute response to hypoxia.

The sessions per patient will be conducted with a 48-hour interval between each one in both groups.

Participants will be asked to sit and breath normally in each exposure.

An attendance checklist will be used to monitor compliance with the intervention
Intervention code [1] 327144 0
Rehabilitation
Intervention code [2] 327667 0
Treatment: Devices
Comparator / control treatment
The Placebo Group (PG) will follow a protocol of 5 cycles of 6 minutes per session with an FiO2 of 21% using the Energy/iAltitude® device (iAltitude Training S.L., Fuenlabrada, Madrid, Spain).

The sessions per patient will be conducted with a 48-hour interval between each one.

Participants will be asked to sit and breath normally in each exposure.

An attendance checklist will be used to monitor compliance with the placebo intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 336258 0
Blood pressure will be assesed using a standard digital sphygmomanometer (Omron HEM-705CP, Omron Healthcare, Inc, Lake Forest, IL)
Timepoint [1] 336258 0
24 hours before intervention and 24 hours after intervention
Primary outcome [2] 336259 0
Pulmonary function
Timepoint [2] 336259 0
24 hours before intervention and 24 hours after intervention
Primary outcome [3] 336260 0
Heart rate variability and heart rate
Timepoint [3] 336260 0
24 hours before intervention and 24 hours after intervention
Secondary outcome [1] 427595 0
Arterial oxygen saturation
Timepoint [1] 427595 0
24 hours before intervention and 24 hours after intervention
Secondary outcome [2] 427597 0
Maximal inspiratory pressure
Timepoint [2] 427597 0
24 hours before intervention and 24 hours after intervention
Secondary outcome [3] 427599 0
C reactive protein
Timepoint [3] 427599 0
24 hours before intervention and 24 hours after intervention

Eligibility
Key inclusion criteria
• Being over 60 years old.
• Having no previous experience in hypoxic training
Minimum age
60 Years
Maximum age
99 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Having any pathology that prevents the performance of physical activity.
• Subjects with impaired cognitive abilities.
• Subjects with pulmonary hypertension, decompensated heart or respiratory failure.
• Subjects who have undergone lower limb surgery within the past 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Qualitative variables will be expressed as absolute numbers and percentages, while quantitative variables will be presented as mean ± standard deviation if they follow a normal distribution, or as median and interquartile range (IQR) if they do not. To check the normality of data distributions, the Kolmogorov-Smirnov test will be employed. For the comparison of qualitative variables, the X2 test or Fisher's exact test will be used when necessary. For the comparison of quantitative variables, the Student's t-test will be applied if they follow a normal distribution, or the Mann-Whitney U test otherwise. Statistically significant values will be considered for P values less than 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/02/2024
Actual
Date of last participant enrolment
Anticipated
9/04/2024
Actual
Date of last data collection
Anticipated
16/04/2024
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 25851 0
Spain
State/province [1] 25851 0
Toledo

Funding & Sponsors
Funding source category [1] 314968 0
Self funded/Unfunded
Name [1] 314968 0
None
Country [1] 314968 0
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country
Spain
Secondary sponsor category [1] 316966 0
None
Name [1] 316966 0
Address [1] 316966 0
Country [1] 316966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313942 0
CEIC Toledo
Ethics committee address [1] 313942 0
Avda. Río Guadiana, s/n, edificio B. 45007, Toledo (Spain)
Ethics committee country [1] 313942 0
Spain
Date submitted for ethics approval [1] 313942 0
04/09/2023
Approval date [1] 313942 0
27/09/2023
Ethics approval number [1] 313942 0
1071

Summary
Brief summary
The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.

According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, blood pressure, arterial oxygen saturation and inflamatory biomarkers.

The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo a 6-weeks IHHE protocol, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The placebo group will undergo a 5-cycle protocol with an FiO2 of 21% during 6 weeks.

The sessions per patient will be conducted with a 48-hour interval between each one in both groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129866 0
Prof Arturo Ladriñán Maestro
Address 129866 0
Campus Tecnológico Fábrica de Armas, Avenida Carlos III S/N, 45071 Toledo
Country 129866 0
Spain
Phone 129866 0
+34 615274176
Fax 129866 0
Email 129866 0
arturo.ladrinan@uclm.es
Contact person for public queries
Name 129867 0
Dr Alberto Sánchez Sierra
Address 129867 0
Campus Tecnológico Fábrica de Armas, Avenida Carlos III S/N, 45071 Toledo
Country 129867 0
Spain
Phone 129867 0
+34 608801238
Fax 129867 0
Email 129867 0
alberto.sanchez@uclm.es
Contact person for scientific queries
Name 129868 0
Dr Alberto Sánchez Sierra
Address 129868 0
Campus Tecnológico Fábrica de Armas, Avenida Carlos III S/N, 45071 Toledo
Country 129868 0
Spain
Phone 129868 0
+34 608801238
Fax 129868 0
Email 129868 0
alberto.sanchez@uclm.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Inmediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Principal Investigator (arturo.ladrinan@uclm.es)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20590Ethical approval    386702-(Uploaded-05-10-2023-10-54-26)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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