Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000130561
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
A randomised controlled trial investigating the cardiorespiratory effects of a single hypoxia-hyperoxia exposure session in elderly adults.
Scientific title
Influence of a hypoxia-hyperoxia exposure session on elderly participants cardiorespiratory condition, blood pressure, and oxygen saturation. Randomized double-blind placebo-controlled clinical trial'.
Secondary ID [1] 310233 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly 330932 0
Condition category
Condition code
Cardiovascular 327732 327732 0 0
Normal development and function of the cardiovascular system
Respiratory 327733 327733 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The EG (Experimental Group) will undergo asingle session of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) session using the Energy/iAltitude® device (iAltitude Training S.L., Fuenlabrada, Madrid, Spain). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, followed by 1-3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 4-8 cycles, depending on their acute response to hypoxia.

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] 326626 0
Rehabilitation
Intervention code [2] 327668 0
Treatment: Devices
Comparator / control treatment
The Placebo Group (PG) will follow a single session 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).


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] 335515 0
Blood pressure will be assesed using a standard digital sphygmomanometer (Omron HEM-705CP, Omron Healthcare, Inc, Lake Forest, IL)
Timepoint [1] 335515 0
Immediately before intervention and immediately after intervention
Primary outcome [2] 335516 0
Pulmonary function will be assessed using the Air Smart Spirometer (Pond Healthcare Innovation, Sweden)
Timepoint [2] 335516 0
Immediately before intervention and immediately after intervention
Primary outcome [3] 335517 0
Heart rate variability will be assessed using a device Polar H10 (Polar Electro Oy, Kempele, Finland).
Timepoint [3] 335517 0
Immediately before intervention and immediately after intervention
Secondary outcome [1] 424891 0
Arterial oxygen saturation will be assessed using a device Nonin® 3230 (Nonin Medical, Inc. Plymouth, MN, EEUU)
Timepoint [1] 424891 0
Immediately before intervention and immediatelyafter intervention
Secondary outcome [2] 424892 0
Maximal inspiratory pressure (MIP) will be assessed using the device MicroRPM® (MicroMedical, UK).
Timepoint [2] 424892 0
Immediately before intervention and immediately 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 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
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 Chi square 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
27/02/2024
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 25680 0
Spain
State/province [1] 25680 0
Toledo

Funding & Sponsors
Funding source category [1] 314446 0
Self funded/Unfunded
Name [1] 314446 0
None
Country [1] 314446 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] 316384 0
None
Name [1] 316384 0
Address [1] 316384 0
Country [1] 316384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313486 0
CEIC Toledo
Ethics committee address [1] 313486 0
Ethics committee country [1] 313486 0
Spain
Date submitted for ethics approval [1] 313486 0
04/09/2023
Approval date [1] 313486 0
27/09/2023
Ethics approval number [1] 313486 0
1071

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128338 0
Prof Arturo Ladriñán Maestro
Address 128338 0
Campus Tecnológico Fábrica de Armas, Avenida Carlos III S/N, 45071 Toledo
Country 128338 0
Spain
Phone 128338 0
+34 615274176
Fax 128338 0
Email 128338 0
[email protected]
Contact person for public queries
Name 128339 0
Alberto Sánchez Sierra
Address 128339 0
Campus Tecnológico Fábrica de Armas, Avenida Carlos III S/N, 45071 Toledo
Country 128339 0
Spain
Phone 128339 0
+34 608801238
Fax 128339 0
Email 128339 0
[email protected]
Contact person for scientific queries
Name 128340 0
Alberto Sánchez Sierra
Address 128340 0
Campus Tecnológico Fábrica de Armas, Avenida Carlos III S/N, 45071 Toledo
Country 128340 0
Spain
Phone 128340 0
+34 608801238
Fax 128340 0
Email 128340 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Inmediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20586Informed consent form    Study-related document.docx
20587Ethical approval    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
No additional documents have been identified.