Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000380493
Ethics application status
Approved
Date submitted
4/08/2015
Date registered
23/03/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effects of the vagal stimulation in patients with coronary disease.
Scientific title
Short-term effects of thoracic and abdominal lymphatic pump techniques with vagal stimulation on blood pressure and markers of cardiac stress in patients with coronary heart disease.
Secondary ID [1] 287108 0
NONE
Universal Trial Number (UTN)
U1111-1172-3197
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart disease 295634 0
Condition category
Condition code
Cardiovascular 295915 295915 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

INTERVENTION:

1.The patient must be in the right lateral decubitus position.
2.The patient will be asked to breathe deeply using their diaphragm for 2 minutes prior to the lymphatic pump rib cage compression.
3. The compression of the rib cage is the procedure that will be used to create a lymphatic pump; this compression is achieved manually by a physiotherapist and there is only one technique: thoracic and abdominal lymphatic pump technique.
4.We will check the level of saliva in the mouth by testing for the salivary secretion rate.
5.For vagus nerve stimulation to be possible, we need diaphragmatic breathing and to have sufficient salivary secretion in his mouth whilst the thoracic and abdominal lymphatic pump technique is being performed.

Treatment sessions: 12 sessions delivered 2 per week over 6 weeks. Each treatment session lasts 10 minutes.
We will administer 5 rib cage compressions repeated for 5 respiratory cycles.

We will determine if there has been vagal stimulation if, during the lymphatic pump via rib cage compression, the salivary secretion in the mouth has increased. Lymphatic pump techniques and vagal stimulation are carried out in addition to the standard care rehabilitation protocol recommended by cardiologists
Intervention code [1] 292362 0
Treatment: Other
Comparator / control treatment
Standard care control gorup will receive back and chest massage

Control group
Active

Outcomes
Primary outcome [1] 295601 0
systolic blood pressure using sphygmomanometer
Timepoint [1] 295601 0
6 weeks after commencement of intervention period.
Primary outcome [2] 295602 0
diastolic blood pressure using sphygmomanometer
Timepoint [2] 295602 0
6 weeks after commencement of intervention period.
Primary outcome [3] 295603 0
maximal oxygen uptake (VO2 max)using the Cooper test
Timepoint [3] 295603 0
6 weeks after commencement of intervention period
Secondary outcome [1] 315960 0
catecholamines using blood sample
Timepoint [1] 315960 0
6 weeks after commencement of intervention period
Secondary outcome [2] 315961 0
cortisol using blood sample
Timepoint [2] 315961 0
6 weeks after commencement of intervention period.
Secondary outcome [3] 315962 0
hdl-cholesterol using blood sample
Timepoint [3] 315962 0
6 weeks after commencement of intervention period.
Secondary outcome [4] 315963 0
cholesterol using blood sample
Timepoint [4] 315963 0
6 weeks after commencement of intervention period.

Eligibility
Key inclusion criteria
Coronary heart disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery for coronary heart disease in the past 3 years and concomitant disease were excluded

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)
Randomisation was carried out using randomization.com online computer software.
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was carried out using randomization.com online computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
3/10/2016
Actual
5/09/2016
Date of last participant enrolment
Anticipated
Actual
9/01/2017
Date of last data collection
Anticipated
16/03/2017
Actual
16/03/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7065 0
Spain
State/province [1] 7065 0
Malaga

Funding & Sponsors
Funding source category [1] 291761 0
University
Name [1] 291761 0
University of Seville
Country [1] 291761 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
C/ AVICENA, S/N C.P: 41009 (SEVILLA)
Country
Spain
Secondary sponsor category [1] 290430 0
Other
Name [1] 290430 0
International School of Osteopathy (MADRID)
Address [1] 290430 0
Calle de Saturnino Calleja, 1, 28002 Madrid, Community of Madrid
Country [1] 290430 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293280 0
Ethics Committee Board of Andalusia
Ethics committee address [1] 293280 0
Ethics committee country [1] 293280 0
Spain
Date submitted for ethics approval [1] 293280 0
01/01/2015
Approval date [1] 293280 0
24/11/2015
Ethics approval number [1] 293280 0

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

Contacts
Principal investigator
Name 58862 0
Mr Luis Martos Vega
Address 58862 0
Pje San Fernando 5 1-c esc dcha
29002 Malaga Spain
LUIS MARTOS VEGA
School of osteopathy Madrid
Country 58862 0
Spain
Phone 58862 0
+34952317058
Fax 58862 0
Email 58862 0
[email protected]
Contact person for public queries
Name 58863 0
Luis Martos Vega
Address 58863 0
Pje San Fernando 5, 1-C esc dcha
29002 Malaga Spain

Luis Martos Vega
School of Osteopathy Madrid
Country 58863 0
Spain
Phone 58863 0
+34952317058
Fax 58863 0
Email 58863 0
[email protected]
Contact person for scientific queries
Name 58864 0
Cleofas Rodriguez Blanco
Address 58864 0
C/ AVICENA, S/N C.P: 41009 (SEVILLA)
UNIVERSIDAD DE SEVILLE Physiotherapy Department
Country 58864 0
Spain
Phone 58864 0
+34952317058
Fax 58864 0
Email 58864 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
No additional documents have been identified.