Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001350112
Ethics application status
Approved
Date submitted
5/06/2019
Date registered
1/10/2019
Date last updated
1/10/2019
Date data sharing statement initially provided
1/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of endurance training conducted under hypoxia conditions on change in exercise tolerance of patients with ischemic heart disease treated with angioplasty or bypass grafting.
Scientific title
Impact of endurance training conducted under hypoxia conditions on change in exercise tolerance of patients with ischemic heart disease treated with angioplasty or bypass grafting.
Secondary ID [1] 298663 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary artery disease 313167 0
heart failure 313168 0
exercise tolerance 313169 0
Condition category
Condition code
Cardiovascular 311631 311631 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50 patients participated in 24 endurance trainings in normobaric hypoxia conditions. Trainings were conducted every day feom Monday to Friday and lasted about 1 hour (30 minutes for adaptation and 30 minutes of training). Intensity of each session depended on the results of first stress test but never exceeded 85% of HRmax.
Before trainings they had spiroergometric treadmill stress test and blood tests. These same was after training programme.
1. Before trainings each aptient uderwent:
- spiroergometric test (made by physiotherapist or nurse) according to Bruce protocol
- blood tests (morphologycal parameters, lipids, Interleucine alpha, gasometic parameters, electrolytes (made by nurse in analtical laboratory)
- body mass and composition (In body)

After these each patient participated in 24-days trainings programme on cycloergometer in normobaric hypoxia conditions (chamber of normobaric hypoxia).
a) All sessions were supervsored by physiotherapist and paramedic
b) Mode of administration was group of 4 patients trained at the time
c) Intensity was selected individually depending on the results of the treadmill test (at the begining of programme)
d) duration of session- 1 hour (30' of adaptation, 30' of proper training)
e) total duration of intervention- 24 days
f) Strategies used to assess and monitor adherence to the intervention- session attendence checklists
2. Type of workout- endurance workout done on cycloergometer
3. Normobaric hypoxia conditions means that level of oxygen in the air was lower (these same as on 2000m a.s.l., it is about 16% of oxygen) but pressure of the air is these same as normal

After finishing trainings patients had all examinations and tests as in first day (in normoxia condiotions). Results were compared.
Intervention code [1] 314680 0
Rehabilitation
Intervention code [2] 315351 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320324 0
exercise tolerance measured by results of spiroergometric treadmil test
Timepoint [1] 320324 0
26 days (24 days of trainings + 2 days of tests)
Primary outcome [2] 320325 0
level of lactate in the blood
Timepoint [2] 320325 0
post-treadmil test (that was made before and after training programme)
Primary outcome [3] 320634 0
duration time of endurance test (measured by stopwatch)
Timepoint [3] 320634 0
after endurance test (before and after training programme)
Secondary outcome [1] 371252 0
changes in blood parameters (morphology, fat acids, electrolytes) as a composite secondary outcome
Timepoint [1] 371252 0
Pre- and post- training programme. Blood was collected twice- before training programe and after finish it.

Eligibility
Key inclusion criteria
ischemic heart disease treated with angioplasty or bypass grafting,
age 35-85 years
participation in rehabilitation programme previously
model A of cardiac rehabilitation (>10MET)
Minimum age
35 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age over 85 years, any other than A model of rehabilitation programme,
other inflamatory diseases, lack of disease history

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
1/03/2019
Date of last data collection
Anticipated
Actual
1/04/2019
Sample size
Target
50
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 21581 0
Poland
State/province [1] 21581 0
Katowice

Funding & Sponsors
Funding source category [1] 302981 0
University
Name [1] 302981 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 302981 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education
Address
ul. Mikolowska 72a
40-065 Katowice
Country
Poland
Secondary sponsor category [1] 302936 0
None
Name [1] 302936 0
none
Address [1] 302936 0
none
Country [1] 302936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303531 0
Academic's Bioethic Committee at the Jerzy Kukuczka Academy of Physical Education
Ethics committee address [1] 303531 0
Ethics committee country [1] 303531 0
Poland
Date submitted for ethics approval [1] 303531 0
Approval date [1] 303531 0
27/03/2017
Ethics approval number [1] 303531 0

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

Contacts
Principal investigator
Name 93986 0
Dr Agata Nowak
Address 93986 0
Dr Agata Nowak
Jerzy Kukuczka Academy of Physiacl Education,
ul. Mikolowska 72a
40-065 Katowice
Country 93986 0
Poland
Phone 93986 0
+48 501773925
Fax 93986 0
Email 93986 0
[email protected]
Contact person for public queries
Name 93987 0
Agata Nowak
Address 93987 0
Dr Agata Nowak
Jerzy Kukuczka Academy of Physiacl Education,
ul. Mikolowska 72a
40-065 Katowice
Country 93987 0
Poland
Phone 93987 0
+48 501773925
Fax 93987 0
Email 93987 0
[email protected]
Contact person for scientific queries
Name 93988 0
Agata Nowak
Address 93988 0
Dr Agata Nowak
Jerzy Kukuczka Academy of Physiacl Education,
ul. Mikolowska 72a
40-065 Katowice
Country 93988 0
Poland
Phone 93988 0
+48 501773925
Fax 93988 0
Email 93988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
results of treadmill tests, blood tests. Comparision of tests results before and after training programme
When will data be available (start and end dates)?
start: 1.02.2019 and no end date
Available to whom?
scientific journals, conferences and symposium
Available for what types of analyses?
correlations, statistical analyzes
How or where can data be obtained?
Access subject to approvals by Principal Investigator and medical journals
contact to principal investigator: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4039Ethical approval    377732-(Uploaded-13-08-2019-22-38-28)-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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