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Trial registered on ANZCTR
Registration number
ACTRN12623001046695
Ethics application status
Approved
Date submitted
6/09/2023
Date registered
27/09/2023
Date last updated
27/09/2023
Date data sharing statement initially provided
27/09/2023
Date results information initially provided
27/09/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effects of simulated altitude on the physiological responses of older adults to strength training.
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Scientific title
The effects of normobaric hypoxia on the physiological responses of older adults to resistance exercise.
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Secondary ID [1]
310552
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NIL
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ageing
331384
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Hypoxia
331474
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Condition category
Condition code
Musculoskeletal
328133
328133
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0
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Other muscular and skeletal disorders
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Cardiovascular
328201
328201
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0
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Normal development and function of the cardiovascular system
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Respiratory
328202
328202
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0
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Normal development and function of the respiratory system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants complete either 8 weeks of strength training in normal environmental conditions (sea level; normoxia) or 8 weeks of strength training in simulated altitude (nornobaric hypoxia).
Hypoxia was generated using a nitrogen enriching machine, that replaced a fraction of oxygen with nitrogen. The selected hypoxia was 14.4% to simulate an altitude of approximately 3,300m above sea level. A trained exercise scientist supervised each training session in a one-on-one session at the University gymnasium. Resistance exercise was performed at 70% of 1 repetition maximum (1RM), using four exercises: leg extension, pectoral fly, standing row and squat. Participants completed 2 sessions weekly for 8 weeks. Each session was approximately 60 minutes in duration.
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Intervention code [1]
326949
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Prevention
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Comparator / control treatment
The control group completes the same strength training as the interventional group, but in normal environmental conditions (normoxia). The nitrogen generator was turned on and providing air that is 20.9% oxygen (normal sea level conditions). Participants in the control group completed identical exercises to the hypoxic group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Muscular strength: measured using 1 repetition maximum testing of a squat exercise at baseline and post-intervention.
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Assessment method [1]
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Timepoint [1]
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Comparison between pre-intervention and after eight weeks of the training intervention.
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Secondary outcome [1]
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Muscle mass: analysed using a DXA scan. Whole body lean body mass will be calculated to determine any changes in overall muscle mass.
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Assessment method [1]
426456
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Timepoint [1]
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Comparison between pre-intervention and after eight weeks of the training intervention.
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Secondary outcome [2]
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Circulating hormones (Glucose, insulin) will be determined using an ELISA assay in venous blood
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Assessment method [2]
426768
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Timepoint [2]
426768
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Analysis at pre- and post-intervention (1 day after the 8 week training intervention)for hormones (Eg. glucose, insulin).
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Secondary outcome [3]
426769
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Circulating immune cells will be quantified using a full blood count on venous blood.
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Assessment method [3]
426769
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Timepoint [3]
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Analysis at pre-intervention and post-intervention (1 day after the 8 week training intervention) for key immune cells (leukocytes).
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Secondary outcome [4]
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Muscular strength: measured using 1 repetition maximum testing of a pectoral fly exercise at baseline and post-intervention.
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Assessment method [4]
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Timepoint [4]
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Measurements will be taken before the intervention and 1 week after the 8 week training intervention.
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Secondary outcome [5]
427055
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Muscular strength: measured using 1 repetition maximum testing of a standing row exercise at baseline and post-intervention.
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Assessment method [5]
427055
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Timepoint [5]
427055
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Measurements will be taken before the intervention and 1 week after the 8 week training intervention.
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Secondary outcome [6]
427056
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Muscular strength: measured using 1 repetition maximum testing of a leg extension exercise at baseline and post-intervention.
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Assessment method [6]
427056
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Timepoint [6]
427056
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Measurements will be taken before the intervention and 1 week after the 8 week training intervention.
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Eligibility
Key inclusion criteria
Healthy adults (male and female) aged 60-75 years old. Participants must be free of diagnosed cardiovascular and respiratory conditions to be included in the study.
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Minimum age
60
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Diagnosed cardiovascular or respiratory condition, musculoskeletal disorder that prevents participant from completing strength training, blood condition (eg. abnormal white blood cell count or anemia).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researchers who determined that participants were eligible for the trial did not know which group they would be allocated to (allocation concealment). Participants were allocated randomly to a group by the primary researcher after enrollment into the study,
Participants exercised in an altitude chamber that was set to either simulated altitude (hypoxia) or normal air conditions.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly allocated to a group using a random number generator. If two participants were enrolled at the same time (for example, a husband and wife), one single random number generator was used and they were both assigned to the same group so that they could perform their training session on the same day (one following the other).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Analysis of variance (ANOVA) if the data are normally distributed to test the effects of time and treatment on our primary outcome.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
6/02/2017
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Date of last participant enrolment
Anticipated
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Actual
15/10/2019
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Date of last data collection
Anticipated
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Actual
3/12/2019
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Sample size
Target
20
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Deakin University
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Address [1]
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75 Pigdons Road, Waurn Ponds, Vic 3216
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Country [1]
314811
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
75 Pigdons Road, Waurn Ponds, Vic 3216
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Country
Australia
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Secondary sponsor category [1]
316738
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None
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Name [1]
316738
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Address [1]
316738
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Country [1]
316738
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Other collaborator category [1]
282809
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Hospital
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Name [1]
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Barwon Health
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Address [1]
282809
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Bellarine St, Geelong, Vic 3220
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Country [1]
282809
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313763
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Deakin University Human Research Ethics Committee (DUHREC)
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Ethics committee address [1]
313763
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75 Pigdons Road, Waurn Ponds, Vic 3216
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Ethics committee country [1]
313763
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Australia
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Date submitted for ethics approval [1]
313763
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30/08/2016
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Approval date [1]
313763
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19/10/2016
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Ethics approval number [1]
313763
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2016-308
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Summary
Brief summary
This study aims to determine if performing strength training in simulated altitude can cause greater improvements in muscle strength and muscle size in older adults, compared to traditional strength training at sea level conditions. The study ultimately aims to help slow the progression of muscle weakness and muscle wasting in older adults. We hypothesise that performing strength training in simulated altitude (termed hypoxia) will enhance the muscle training responses compared to training at sea level.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Craig Wright
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Address
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Deakin University, 75 Pigdons Road, Waurn Ponds Vic, 3216
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Country
129286
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Australia
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Phone
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+61 3 524 79266
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Fax
129286
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Email
129286
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[email protected]
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Contact person for public queries
Name
129287
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Dr Craig Wright
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Address
129287
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Deakin University, 75 Pigdons Road, Waurn Ponds, Vic 3216
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Country
129287
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Australia
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Phone
129287
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+61 3 524 79266
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Fax
129287
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Email
129287
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[email protected]
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Contact person for scientific queries
Name
129288
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Dr Craig Wright
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Address
129288
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Deakin University, 75 Pigdons Road, Waurn Ponds, Vic 3216
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Country
129288
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Australia
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Phone
129288
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+61 3 524 79266
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Fax
129288
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Email
129288
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
We did not seek ethics approval to publish individual data. Our ethics approved us to publish group means only.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20256
Study protocol
386557-(Uploaded-06-09-2023-13-47-24)-Study-related document.docx
20257
Ethical approval
386557-(Uploaded-06-09-2023-13-47-53)-Study-related document.pdf
20258
Informed consent form
386557-(Uploaded-06-09-2023-13-48-40)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
The chronic leukocyte and inflammatory cytokine responses of older adults to resistance training in normobaric hypoxia; a randomized controlled trial
2024
https://doi.org/10.1186/s13102-024-00890-w
N.B. These documents automatically identified may not have been verified by the study sponsor.
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