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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.
Scientific title
The effects of normobaric hypoxia on the physiological responses of older adults to resistance exercise.
Secondary ID [1] 310552 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 331384 0
Hypoxia 331474 0
Condition category
Condition code
Musculoskeletal 328133 328133 0 0
Other muscular and skeletal disorders
Cardiovascular 328201 328201 0 0
Normal development and function of the cardiovascular system
Respiratory 328202 328202 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326949 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 336007 0
Muscular strength: measured using 1 repetition maximum testing of a squat exercise at baseline and post-intervention.
Timepoint [1] 336007 0
Comparison between pre-intervention and after eight weeks of the training intervention.
Secondary outcome [1] 426456 0
Muscle mass: analysed using a DXA scan. Whole body lean body mass will be calculated to determine any changes in overall muscle mass.
Timepoint [1] 426456 0
Comparison between pre-intervention and after eight weeks of the training intervention.
Secondary outcome [2] 426768 0
Circulating hormones (Glucose, insulin) will be determined using an ELISA assay in venous blood
Timepoint [2] 426768 0
Analysis at pre- and post-intervention (1 day after the 8 week training intervention)for hormones (Eg. glucose, insulin).
Secondary outcome [3] 426769 0
Circulating immune cells will be quantified using a full blood count on venous blood.
Timepoint [3] 426769 0
Analysis at pre-intervention and post-intervention (1 day after the 8 week training intervention) for key immune cells (leukocytes).
Secondary outcome [4] 427054 0
Muscular strength: measured using 1 repetition maximum testing of a pectoral fly exercise at baseline and post-intervention.
Timepoint [4] 427054 0
Measurements will be taken before the intervention and 1 week after the 8 week training intervention.
Secondary outcome [5] 427055 0
Muscular strength: measured using 1 repetition maximum testing of a standing row exercise at baseline and post-intervention.
Timepoint [5] 427055 0
Measurements will be taken before the intervention and 1 week after the 8 week training intervention.
Secondary outcome [6] 427056 0
Muscular strength: measured using 1 repetition maximum testing of a leg extension exercise at baseline and post-intervention.
Timepoint [6] 427056 0
Measurements will be taken before the intervention and 1 week after the 8 week training intervention.

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.
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/02/2017
Date of last participant enrolment
Anticipated
Actual
15/10/2019
Date of last data collection
Anticipated
Actual
3/12/2019
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314811 0
University
Name [1] 314811 0
Deakin University
Country [1] 314811 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road, Waurn Ponds, Vic 3216
Country
Australia
Secondary sponsor category [1] 316738 0
None
Name [1] 316738 0
Address [1] 316738 0
Country [1] 316738 0
Other collaborator category [1] 282809 0
Hospital
Name [1] 282809 0
Barwon Health
Address [1] 282809 0
Bellarine St, Geelong, Vic 3220
Country [1] 282809 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313763 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 313763 0
75 Pigdons Road, Waurn Ponds, Vic 3216
Ethics committee country [1] 313763 0
Australia
Date submitted for ethics approval [1] 313763 0
30/08/2016
Approval date [1] 313763 0
19/10/2016
Ethics approval number [1] 313763 0
2016-308

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.
Trial website
Trial related presentations / publications


Public notes

Contacts
Principal investigator
Name 129286 0
Dr Craig Wright
Address 129286 0
Deakin University, 75 Pigdons Road, Waurn Ponds Vic, 3216
Country 129286 0
Australia
Phone 129286 0
+61 3 524 79266
Fax 129286 0
Email 129286 0
[email protected]
Contact person for public queries
Name 129287 0
Craig Wright
Address 129287 0
Deakin University, 75 Pigdons Road, Waurn Ponds, Vic 3216
Country 129287 0
Australia
Phone 129287 0
+61 3 524 79266
Fax 129287 0
Email 129287 0
[email protected]
Contact person for scientific queries
Name 129288 0
Craig Wright
Address 129288 0
Deakin University, 75 Pigdons Road, Waurn Ponds, Vic 3216
Country 129288 0
Australia
Phone 129288 0
+61 3 524 79266
Fax 129288 0
Email 129288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20256Study protocol    386557-(Uploaded-06-09-2023-13-47-24)-Study-related document.docx
20257Ethical approval    386557-(Uploaded-06-09-2023-13-47-53)-Study-related document.pdf
20258Informed 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
SourceTitleYear of PublicationDOI
Dimensions AIThe chronic leukocyte and inflammatory cytokine responses of older adults to resistance training in normobaric hypoxia; a randomized controlled trial2024https://doi.org/10.1186/s13102-024-00890-w
N.B. These documents automatically identified may not have been verified by the study sponsor.