Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001042639
Ethics application status
Approved
Date submitted
17/09/2014
Date registered
26/09/2014
Date last updated
26/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a short term, supervised exercise training intervention on longitudinal left ventricular function in patient with heart failure with preserved ejection fraction
Scientific title
In patients with Heart Failure with Preserved Ejection Fraction (HFPEF), does short term supervised exercise training improve left ventricular longitudinal intrinsic function (global longitudinal strain)?
Secondary ID [1] 285343 0
None
Universal Trial Number (UTN)
U1111-1161-7432
Trial acronym
SET-HFPEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure with preserved ejection fraction 293068 0
Condition category
Condition code
Cardiovascular 293343 293343 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One on one training with physiotherapist or sport trainer or registered nurse.
The exercise training will be 1 hour per day, 5 times a week for one month.
Intermittent and interval walking with upgrading to treadmill after two weeks exercise. Intermittent and interval waking protocol is 3 mins x fast paced walking at 70-80% max HR then followed by 2 mins slow recovery walking and repeated for 1 hour.
The exercise walking will be done in division of preventive rehabilitation facility building for 2 weeks duration and changed to treadmill for remaining 2 weeks.
The intensity of exercise is based on 70-80% maximal heart rate and 65% VO2max.
Each patient will be followed up on call and survey to their house.
Intervention code [1] 290259 0
Treatment: Other
Comparator / control treatment
pre and post study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293176 0
global longitudinal strain value (%) using 2D echocardiography speckle tracking imaging
Timepoint [1] 293176 0
at one month after supervised exercise training
Secondary outcome [1] 310506 0
quality of life using Minnesota Living with Heart Failure Questionnaire
Timepoint [1] 310506 0
baseline, 2 weeks and one month during intervention
Secondary outcome [2] 310507 0
functional capacity using 6MWT
Timepoint [2] 310507 0
one month after intervention

Eligibility
Key inclusion criteria
symptomatic HF NYHA class II-III, good LV EF (> 50%), diastolic dysfunction (more than grade I), NT pro BNP > 220pg/ml, BNP > 200 pg/ml, global normokinetic (no regional wall motion abnormality)
Minimum age
55 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
valvular heart disease (more than moderate), pulmonary disease (COPD, moderate to severe asthma), acute coronary syndrome, stable angina pectoris, relevant musculoskeletal disease, symptomatic arrhytmias, BP > 150/100 mmHg

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was counted based on comparative analysis of numerical pairs, statistical power 80%, alpha is 0.1, effect size based on Cohen's d is 0.5, p < 0.05 as a statistical significance, statistical assumption there will be 25 subjects.
Numerical data is characterized in mean and standard deviations. To know the difference between pre and post intervention we do a paired t test or wilcoxons test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 6354 0
Indonesia
State/province [1] 6354 0
DKI Jakarta

Funding & Sponsors
Funding source category [1] 289959 0
Self funded/Unfunded
Name [1] 289959 0
Sidhi Laksono P
Country [1] 289959 0
Indonesia
Primary sponsor type
Individual
Name
Sidhi Laksono Purwowiyoto
Address
Perhimpunan Kardiologi Indonesia (PERKI)
RS Jantung dan Pembuluh Darah Harapan Kita
Jl Letjend S Parman Kav 87 Slipi Jakarta Barat
Country
Indonesia
Secondary sponsor category [1] 288650 0
Individual
Name [1] 288650 0
Budhi Setianto
Address [1] 288650 0
Perhimpunan Kardiologi Indonesia (PERKI)
RS Jantung dan Pembuluh Darah Harapan Kita
Jl Letjend S Parman Kav 87 Slipi Jakarta Barat
Country [1] 288650 0
Indonesia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 51462 0
Dr Sidhi Laksono Purwowiyoto
Address 51462 0
RS Jantung dan Pembuluh Darah Harapan Kita
Jl Letjend S Parman Kav87 Slipi Jakarta Barat 11410
Country 51462 0
Indonesia
Phone 51462 0
62215681111
Fax 51462 0
Email 51462 0
[email protected]
Contact person for public queries
Name 51463 0
Sidhi Laksono Purwowiyoto
Address 51463 0
Perhimpunan Kardiologi Indonesia
RS Jantung dan Pembuluh Darah Harapan Kita
Jl Letjend S Parman Kav 87 Jakarta Barat 11410
Country 51463 0
Indonesia
Phone 51463 0
62218611816
Fax 51463 0
Email 51463 0
[email protected]
Contact person for scientific queries
Name 51464 0
Sidhi Laksono Purwowiyoto
Address 51464 0
Perhimpunan Kardiologi Indonesia (PERKI)
RS Jantung dan Pembuluh Darah Harapan Kita
Jl Letjend S Parman Kav87 Slipi Jakarta Barat 11410
Country 51464 0
Indonesia
Phone 51464 0
62215681111
Fax 51464 0
Email 51464 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExercise Training Improved Longitudinal Intrinsic Left Ventricle Function in Heart Failure with Preserved Ejection Fraction.2019https://dx.doi.org/10.1055/s-0038-1676836
N.B. These documents automatically identified may not have been verified by the study sponsor.