Protocol summary

Study aim
Evaluation of the effect 6 months of combined training with garlic supplementation on coagulation factors (INR, PPT, PT), fibrinogen and platelets in men with DVT
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 40 patients. Excel software rand function was used for randomization.
Settings and conduct
This research was conducted experimentally with a clinical trial design. Subjects in this study included 40 middle-aged men aged 40 to 60 years with deep vein thrombosis (DVT) in Kermanshah. Subjects were available as a sample and met the inclusion criteria. In line with the research objectives, the subjects were randomly divided into four groups; 1. Combined exercise (resistance-aerobic) + garlic supplement (10 people), 2. Combined exercise (10 people), 3. Garlic supplement (10 people) and 4. Control group (10 people) by randomization method using Excel function rand functions were divided. In line with the objectives of the two-way blind study: both the researcher and the participants did not know about the supplement used in the supplement and placebo groups. .
Participants/Inclusion and exclusion criteria
Man Middle age 40 to 60 years With deep vein thrombosis No other diseases No motor disability
Intervention groups
1. Combined exercise group (resistance - aerobic): Combined exercise was performed for 24 weeks with 3 sessions per week. 2. Garlic consumption group: Garlic supplement consumption in the present study was 1200 mg daily as one capsule per day and in the control group placebo (1200 mg starch) was used. Garlic extract capsules were obtained from the Ministry of Agriculture and the Ministry of Agriculture. 3. Combined exercise group and garlic consumption: included both combined exercise and the use of garlic supplements. 4. Control group: It was the use of placebo.
Main outcome variables
Combined exercise; Garlic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210718051924N1
Registration date: 2021-08-22, 1400/05/31
Registration timing: retrospective

Last update: 2021-08-22, 1400/05/31
Update count: 0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Hamed Saed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 8035
Email address
hamedsaed1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
2020-07-22, 1399/05/01
Actual recruitment end date
2021-01-20, 1399/11/01
Trial completion date
2021-01-29, 1399/11/10
Scientific title
The effect of a six-month combined care program with garlic supplementation on coagulation factors (INR, PTT, PT), Fibrinogen and platelets in middle-aged men with deep vein thrombosis (DVT)
Public title
The effect of a course of exercise with garlic supplementation on some coagulation factors in middle-aged men with deep vein thrombosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Middle-aged men 40 to 60 years old with deep vein thrombosis (DVT) in Kermanshah
Exclusion criteria:
Age
From 40 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the library, field and laboratory methods, measures were taken to collect information about the intervention. After identifying individuals with deep vein thrombosis (DVT) and selecting the research sample, the participants' consent to complete the study was completed. After obtaining the consent to participate in the research, the samples were randomly divided into 4 groups of 10 people: Group 1: Resistance (who performed the designed combined exercises) 2: Garlic consumption group (who consumed garlic according to the plan) 3: Combined exercise with garlic (who did the designed combined exercises and also consumed garlic) 4: Control (did not participate in any of the sports activities) Group 1, 8 weeks, did 3 sessions of combined exercise every week. All exercise programs, starting with the principle of overload, increasingly started from the first week and continued until the end of the eighth week. The experiments were performed in two stages, one day before the first training session (pre-test) and 48 hours after the last training session (post-test) in the eighth week of training, after 10 to 12 hours of fasting. It should be noted that all subjects, in addition to the intervention, continued to take warfarin tablets to the extent prescribed by the doctor for each person during the treatment period, and the amount and timing was determined by each person's doctor. The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the researcher and the participants
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.KUMS.REC.1399.1035

Health conditions studied

1

Description of health condition studied
Deep vein thrombosis (DVT)
ICD-10 code
I82.4
ICD-10 code description
Acute embolism and thrombosis of deep veins of lower extremity

Primary outcomes

1

Description
Prothrombin Time (PT)Partial Thromboplastin Time (PTT)International Normalization Ratio (INR), Fibrinogen, platelets
Timepoint
24 hours before the start of the study and 48 hours after the last training session after 24 weeks
Method of measurement
It was measured by class coagulation method with laboratory kits (ACL) and fully automatic device (ACL 8000 made in Italy).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Combined exercise (resistance training + aerobic exercise): The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down.
Category
Treatment - Drugs

2

Description
Intervention group 2: Use of garlic supplement: Garlic supplement consumption in the present study was 1200 mg daily as one capsule per day and in the control group placebo (1200 mg of starch) was used. The garlic extract was prepared from the American Nature Company with a health license from the General Directorate of Food Supervision of the Ministry of Health.
Category
Treatment - Drugs

3

Description
Intervention group 3: Combined exercise (resistance training + aerobic exercise): The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down. Garlic supplement consumption in the present study was 1200 mg daily as one capsule per day and in the control group placebo (1200 mg of starch) was used. The garlic extract was prepared from the American Nature Company with a health license from the General Directorate of Food Supervision of the Ministry of Health.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Kermanshah
Full name of responsible person
Dr. Mohammadreza sobheih
Street address
No. 17, Nurse Blvd, Sorkheh Lijeh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6301
Email
mreza.sobhiyeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sedigheh Hossainpoordelavar
Street address
Islamic Azad University, Kermanshah Branch
City
Kermanshah
Province
Kermanshah
Postal code
6718997551
Phone
+98 83 3724 3181
Email
Delavar2009@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Saed
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 24, Shahid Khanmohammadi Fourth Alley, 18 meters from the first street, Jihad Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715788638
Phone
+98 83 3432 8035
Email
hamedsaed1@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Saed
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 24, Shahid Khanmohammadi Fourth Alley, 18 meters from the first street, Jihad Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715788638
Phone
+98 83 3432 8035
Email
hamedsaed1@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Saed
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 24, Shahid Khanmohammadi Fourth Alley, 18 meters from the first street, Jihad Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715788638
Phone
+98 83 3432 8035
Fax
Email
hamedsaed1@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the study, I will make the result transparently available for publication in the Islamic Azad University, Kermanshah Branch.
When the data will become available and for how long
After the end of the study in early August 2016
To whom data/document is available
Islamic Azad University, Kermanshah Branch
Under which criteria data/document could be used
To inform patients of deep vein thrombosis treated with warfarin about the risk of blood clots or leg bleeding regarding recovery after using one of these study methods
From where data/document is obtainable
Hamed Saed
What processes are involved for a request to access data/document
The request must be in writing and from the Islamic Azad University of Kermanshah
Comments
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