Effect of 8-Week Combined Training (Endurance and Resistance ) with Q10 Supplementation on Antioxidant Balance and Lipid Profile in Elderly People
Design
The randomized placebo-controlled trial with 40 subjects divided into 4 parallel groups
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 a 20 minutes and daily intake of Q10 supplement on antioxidant balance serum levels and lipid profile in 40 elderly people aged 60-75 years in Tehran. In this study, kit Elisa and Physical Activity Questionnaire were used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy people 60 to 75 years old who do not suffer 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 prohibition on exercise or talking Q10 supplement.
Exclusion criteria: People with the mentioned diseases and people who were taking medication.
Intervention groups
Training group, Q10 supplementation group, Q10 supplementation and training group , Control group
Main outcome variables
Antioxidant balance serum and lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200628047942N1
Registration date:2020-09-08, 1399/06/18
Registration timing:retrospective
Last update:2020-09-08, 1399/06/18
Update count:0
Registration date
2020-09-08, 1399/06/18
Registrant information
Name
Sahar Salekani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4422 2628
Email address
sahra.slk10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
2020-02-24, 1398/12/05
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-07-22, 1399/05/01
Scientific title
Effect of 8 - weeks Combined Training ( endurance and resistance ) with Q10 Supplementation on Antioxidant Balance and Lipid Profile in Elderly People
Public title
Exercise at home and taking Q10 supplement in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
An elderly person with age 60 to 70
Speaking in Farsi
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
Exclusion criteria:
Active people based on the questionnaire
Have any known mental illness (psychosis)
Being less than 60 or more than 75 years old
Age
From 60 years old to 75 years old
Gender
Both
Phase
3
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
2020-06-22, 1399/04/02
Ethics committee reference number
IR.SSRC.REC.1399.059
Health conditions studied
1
Description of health condition studied
Antioxidant and lipid profile disorders in elderlies
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Antioxidant Balance
Timepoint
Before the intervention and 48 hours after the end of 8-week exercise and supplementation interventions
Method of measurement
Serum Concentration Measurement Using ELISA Laoratory Kit
Secondary outcomes
1
Description
Lipid Profile
Timepoint
Before the intervention and 48 hours after the end of the 8-week exercise and supplementation interventions
Method of measurement
Serum Concentration Measurement Using ELISA Laboratory Kit
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 8 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: People took two 100 mg capsules of Q10 supplement every morning and evening with food for 8 weeks, using a 100 mg Q10 Plus Euro Vital capsule made in Germany.
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 8 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.Intervention group: People took two 100 mg capsules of Q10 supplement every morning and evening with food for 8 weeks, using a 100 mg Q10 Plus Euro Vital capsule made in Germany.
Category
N/A
4
Description
Control group: Taking placebo every day for 8 weeks, two capsules containing wheat flour were used, which were similar in packaging, color, and taste to the Q10 supplement.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Science and Research branch of Islamic Azad University
Full name of responsible person
Sahar Salekani
Street address
Science and Research branch of Islamic Azad University, End of Sattari Expresseay, Shohada Hesarak University Blv
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
sahar.slk10@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Street address
Science and Research branch of Islamic Azad University , End of Sattari Expressway, Shohada Hesarak University Blv
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
sahar.slk10@gmail.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
100
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
Sahar Salekani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
No 2, West Vahdati, Nahid St, Marzdaran Blv
City
Tehran
Province
Tehran
Postal code
1461714751
Phone
+98 21 4422 2628
Email
sahar.slk10@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahar Salekani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
No 2, West vahdati, Nahid St, Marzdaran Blv
City
Tehran
Province
Tehran
Postal code
1461714751
Phone
+98 21 4422 2628
Email
sahar.slk10@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahar Salekani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
No 2, West vahdati, Nahid St, Marzdaran Blv
City
Tehran
Province
Tehran
Postal code
1461714751
Phone
+98 21 4422 2628
Email
sahar.slk10@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available