The effect of twelve weeks of physical activity with Ginkgobiloba supplementation on the serum levels of brain-derived neurotrophic factor and elderly patients lifestyle
The effect of twelve weeks of physical activity with Ginkgobiloba supplementation on the serum levels of brain-derived neurotrophic factor and elderly patients lifestyle
Design
The clinical trial consisted of a control group, with parallel, randomized groups, 40 subjects in each group and 10 in each group.
Settings and conduct
The purpose of this study was to determine the effect of 12 weeks of aerobic and resistance exercise 5 days a week for 20 minutes and daily intake of Ginkgo biloba supplement on BDNF serum levels and quality of life in 40 elderly people aged 60-75 years in Tehran. In this study, Kit Elisa, Quality of Life questionnaire and Physical Activity Questionnaire were used.
Participants/Inclusion and exclusion criteria
inclusion criteria: Old and healthy people 60 to 75 years old, who do not suffering from heart, bone, brain, kidney, liver, respiratory and hormonal diseases. Be inactive and do not do any physical activity during the week. Do not have a medical ban on exercising or taking ginkgo Biloba supplements
exclusion criteria: Using Cigarette or drug, antioxidant supplements or various anti-inflammatory drugs
Intervention groups
Ginkgo biloba supplementation exercise group, Ginkgo biloba supplementation exercise control group
Main outcome variables
Brain derived neurotrophic factor (BDNF) serum level and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191223045864N1
Registration date:2020-01-31, 1398/11/11
Registration timing:retrospective
Last update:2020-01-31, 1398/11/11
Update count:0
Registration date
2020-01-31, 1398/11/11
Registrant information
Name
shadi Jalalian
Name of organization / entity
Science an research branch of Islamic azad university
Country
Iran (Islamic Republic of)
Phone
+98 21 8837 6044
Email address
shadijalalian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
2019-02-12, 1397/11/23
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-07-16, 1398/04/25
Scientific title
The effect of twelve weeks of physical activity with Ginkgobiloba supplementation on the serum levels of brain-derived neurotrophic factor and elderly patients lifestyle
Public title
The effect of twelve weeks of physical activity with Ginkgobiloba supplementation on the serum levels of brain-derived neurotrophic factor and elderly patients lifestyle
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
An elderly person with age 60 to 70
Having Iranian nationality
Speaking in persian
Being completely cautious during this study
Having communication ability
Having ability to answer the questionnaires.
living in Tehran.
Being inactive and do not have any physical activity or exercise during the week
Do not have any known mental illness (psychosis)
Exclusion criteria:
Active people based on the questionnaire
Opt out of answering the questionnaire while doing the job and interview
Refrain from running the exercise or supplement you are looking for
Unwanted things have happened
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was simple, individual, and sealed using envelopes. So that the names of ten subjects were written in four envelopes and in each one. Then, each of the intervention and control groups was assigned A, B, C, D codes and randomly assigned to one of the training, supplement, exercise, and control groups. Making the envelope, it was determined in which group each of the subjects belonged.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sport Sciences Research institute of Iran
Street address
No.3, 5th Ave, Miremad St, Motaharri St
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.SSRC.REC.1398.116
Health conditions studied
1
Description of health condition studied
aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Brain derived neurotrophic factor serum level
Timepoint
Before the intervention and 48 hours after the end of the 12-week exercise and supplementation interventions
Method of measurement
Serum Concentration Measurement Using ELISA Laboratory Kit
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention and 48 hours after the end of the 12-week exercise and supplementation interventions
Method of measurement
SF-36 Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: Exercise including 5 minutes warm-up and 5 minutes of balance and walking movements and 5 minutes of progressive resistance training and 5 minutes of cooling which were performed for a total of 20 minutes for 5 days a week for 12 weeks. The training method was progressive and according to the level of ability of individuals. With 0.5, 0.75, 1.5 and 1.5 kg weights and 8 repetitive bands for knee extension, flexion and lift, hip extension, flexion, arm back and ankle support movements from sitting to standing. The probability of increasing the number of repetitions could be increased up to 12 times with the Borg pressure scale of 12 to 14. Balance and aerobic movements included walking, lifting on toes, lifting on heels, knee lifting, standing on one leg, shifting body weight in different directions, standing on two legs with or without the help of a chair.
Category
N/A
2
Description
Intervention group: Fasting subjects received a daily dose of 240 mg of ginkgo biloba supplement for 12 weeks.
Category
N/A
3
Description
Intervention group: Exercise including 5 minutes warm-up and 5 minutes of balance and walking movements and 5 minutes of progressive resistance training and 5 minutes of cooling which were performed for a total of 20 minutes for 5 days a week for 12 weeks. The training method was progressive and according to the level of ability of individuals. With 0.5, 0.75, 1.5 and 1.5 kg weights and 8 repetitive bands for knee extension, flexion and lift, hip extension, flexion, arm back and ankle support movements from sitting to standing. The probability of increasing the number of repetitions could be increased up to 12 times with the Borg pressure scale of 12 to 14. Balance and aerobic movements included lifting on toes, lifting on heels, knee lifting, standing on one leg, shifting body weight in different directions, standing on two legs with the help of a chair and without walking. Intervention group: Fasting subjects received a daily dose of 240 mg of ginkgo biloba supplement for 12 weeks and used 200 mg of ginkgo biloba mark made of French Vitarmonil.
Category
N/A
4
Description
Control group: A placebo was given daily for 12 weeks with a cellulose capsule that was similar in color to the contents of the ginkgo biloba capsule.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sceince and Research branch of Islamic Azad University
Full name of responsible person
Shadi Jalalian
Street address
Sceince and Research branch of Islamic Azad University,End of Sattari Expressway, Shohada Hesarak University Boulevard (Student)
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
shadijalalian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sceince and Research branch of Islamic Azad University
Full name of responsible person
Farshad Ghazalian
Street address
Sceince and Research branch of Islamic Azad University,End of Sattari Expressway, Shohada Hesarak University Boulevard (Student)
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
Phdghazalian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sceince and Research branch of Islamic Azad University
Proportion provided by this source
50
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
Sceince and Research branch of Islamic Azad University,
Full name of responsible person
Shadi Jalalian
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
No 32, East Safa Ave, Sa'adi St, Darya Blv, Shahrak-e-Gharb
City
Tehran
Province
Tehran
Postal code
1466936184
Phone
+98 21 8837 6044
Email
Shadijalalian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sceince and Research branch of Islamic Azad University
Full name of responsible person
Shadi Jalalian
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
No 32, East Safa Ave, Sa'adi St, Darya Blv, Shahrak-e-Ghar
City
Tehran
Province
Tehran
Postal code
1466936184
Phone
+98 21 8837 6044
Email
Shadijalalian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sceince and Research branch of Islamic Azad University
Full name of responsible person
Shadi Jalalian
Position
Student
Latest degree
Master
Other areas of specialty/work
sport physiology
Street address
No 32, East Safa Ave, Sa'adi St, Darya Blv, Shahrak-e-Gharb
City
Tehran
Province
Tehran
Postal code
1466936184
Phone
+98 21 8837 6044
Email
Shadijalalian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD