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Trial registered on ANZCTR


Registration number
ACTRN12624000173594
Ethics application status
Approved
Date submitted
17/11/2023
Date registered
23/02/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Isometric wall squat training as an adjuvant to blood pressure control. A Multicentric study in Latin America
Scientific title
The effect of isometric wall squat training on blood pressure control in patients with hypertension: A multicentric study in Latin America
Secondary ID [1] 310770 0
None
Universal Trial Number (UTN)
Trial acronym
EEFIT 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High blood pressure 331728 0
Condition category
Condition code
Cardiovascular 328475 328475 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before the intervention will be necessary determine the level of training which is given in degrees of knee flexion.
To the initial test, participant will stand up straight with feet separated to the hip width with a wall positioned behind, then walk forward extending the shoulders until hands can remain touching the wall, then will lean the back and buttocks against the wall and slide down the wall until reach a 95 degrees angle of knees flexion. Ensuring back and buttocks remain in contact with the wall all the time.
The angle of the joint will be measured with a wooden goniometer, previously adjusted to the subject's leg with Velcro strips. The lateral epicondyle of the femur and the greater trochanter will be taken as a reference for one arm of the goniometer and the other in the lateral midline of the fibula using the lateral malleolus and the head of the fibula as a reference. Immediately the subject is in position, 2 minutes will begin to be counted.
If the participant does not pass the initial test at 95°, he/she must start at Level 1 (135º) of the training, if he/she pass it, they will start at Level 2 (125º).

After defining the level at which the participant starts, the training take place 3 times a week, maintaining the position for 2 minutes until completing 4 sets, leaving 2 minutes between sets. The length of the weeks will depend on each level. The hands should be placed crossed on the chest and the angle of each level will be measured with the wooden goniometer fixed at the same reference points as the initial evaluation. Levels 1 (135º), 2 (125º) and 3 (115º) will be done for 2 weeks each, while levels 4 (105º) and 5 (95º) will be done for 3 weeks each for a total of 12 weeks. The next 12 weeks, once a week at level 5 (95º).

LEVELS OF TRAINING
If participant pass initial test:
Week 1: 125º
Week 2, 3: Between 125º - 115º
Week 4 - 6: Between 115º - 105º
Week 7 – 9: Between 105º - 95º
Week 10 – 24: 95º

If participant do not pass initial test:
Week 1: 135º
Week 2: 135º - 125º
Week 3, 4: Between 125º - 115º
Week 5 - 6: Between 115º - 105º
Week 7 – 9: Between 105º - 95º
Week 10 – 24: 95º

Initial test and intervention training will be delivered by physical therapists, nurses, and physicians (not experience is required), who will be previously training in the evaluation and intervention procedures.
After the initial test, participants will be trained in the intervention plan, and they do it in an independent way at home or in the job place.

To monitor adherence to the intervention the patient will be virtually supervised by the evaluators once a week to make sure the intervention is doing in a right way
Initial test and training, besides they will be ask to register the days when they do the training.
Intervention code [1] 327366 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336549 0
Blood pressure
Timepoint [1] 336549 0
baseline, 4, 8, 12, and 24 weeks after commencing exercise regimen,
Secondary outcome [1] 428767 0
Systolic pressure
Timepoint [1] 428767 0
baseline, 4, 8, 12, and 24 weeks after commencing exercise regimen,

Eligibility
Key inclusion criteria
Patients with new diagnosis of high blood pressure without pharmacological management with Systolic Blood Pressure values > 140 mmHg,
categorized as low risk.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-authorization (non-signing of the informed consent)
suspected secondary hypertension
Diabetes
Severe osteoarthritis pending of knee replacement surgery
Pain on knee that limits physical activity
Pregnancy or breastfeeding

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
A univariate analysis will be carried out, in order to describe the variables according to their measurement scale, applying measures of central tendency and dispersion, according to their nature and distribution, or frequency tables, according to their measurement scale.
The normal distribution of the variables will be evaluated using Shapiro Wilk test.
To evaluate the differences between the measurement groups for the output variables, parametric or non-parametric tests will be applied according to the distribution of the data, in the case of categorical variables Chi square will be implemented and for quantitative variables of normal distribution, the Mann-Whitney test or T test will be applied.
For the primary outcome, a comparison of percentages of hypertension control will be made between the follow-up moments in weeks 4, 8, 12 and 24, overall, and by subgroups.
For the secondary outcome, a comparison will be made of systolic blood pressure averages of dependent populations, between weeks 0, 4, 8, 12 and 24, in the same subgroups defined for the primary outcome.
Additionally, according to the design of this study in a real-life scenario, it will be required, for relevance, to perform the analysis by intention to treat for all participants included according to the information collected.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/12/2025
Actual
Sample size
Target
1500
Accrual to date
27
Final
Recruitment outside Australia
Country [1] 25970 0
Colombia
State/province [1] 25970 0
Country [2] 25971 0
Spain
State/province [2] 25971 0
Country [3] 25972 0
Ecuador
State/province [3] 25972 0
Country [4] 25973 0
Argentina
State/province [4] 25973 0

Funding & Sponsors
Funding source category [1] 315760 0
University
Name [1] 315760 0
University of Santander
Country [1] 315760 0
Colombia
Primary sponsor type
University
Name
University of Santander
Address
Street 70 N° 55-210
Country
Colombia
Secondary sponsor category [1] 317884 0
None
Name [1] 317884 0
Address [1] 317884 0
Country [1] 317884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313972 0
Bioethics Committee of the University of Santander
Ethics committee address [1] 313972 0
Ethics committee country [1] 313972 0
Colombia
Date submitted for ethics approval [1] 313972 0
27/03/2023
Approval date [1] 313972 0
29/03/2023
Ethics approval number [1] 313972 0

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

Contacts
Principal investigator
Name 129974 0
Dr Patricio Lopez Jaramillo
Address 129974 0
University of Santander, Calle 70 N° 55-210, Bucaramanga, Santander, Colombia
Country 129974 0
Colombia
Phone 129974 0
+57 607 6516500
Fax 129974 0
Email 129974 0
pat.lopez@mail.udes.edu.co
Contact person for public queries
Name 129975 0
Zully Rocio Rincon Rueda
Address 129975 0
University of Santander, Calle 70 N° 55-210, Bucaramanga, Santander, Colombia
Country 129975 0
Colombia
Phone 129975 0
+57 607 6516500
Fax 129975 0
Email 129975 0
zu.rincon@mail.udes.edu.co
Contact person for scientific queries
Name 129976 0
Isabela Gomez
Address 129976 0
University of Santander, Calle 70 N° 55-210, Bucaramanga, Santander, Colombia
Country 129976 0
Colombia
Phone 129976 0
+57 607 6516500
Fax 129976 0
Email 129976 0
mgruiz701@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Because de data only can be used by the responsible institution according to Colombian personal data protection law


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20956Study protocol    386729-(Uploaded-17-11-2023-07-57-05)-Study-related document.pdf
20958Informed consent form    386729-(Uploaded-17-11-2023-07-58-12)-Study-related document.pdf
20959Ethical approval    386729-(Uploaded-17-11-2023-07-58-33)-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
No additional documents have been identified.