The overall aim of this study is to investigate the effect of consuming the antioxidant supplement Q10 on the adaptations induced by high-intensity interval exercises in older adults.
Design
A clinical trial with a control group, parallel groups, double-blind, randomized, on 34 elderly individuals
Settings and conduct
This research will be conducted in a gym near the Sports Sciences Laboratory at Isfahan University. The exercise protocol includes a 15-minute high-intensity exercise session (at 85 to 95% of maximum heart rate) on a stationary bike three days a week for eight weeks. Q10 supplement at 100 milligrams and a placebo similar to it will be given daily to the groups over the eight weeks.
Participants/Inclusion and exclusion criteria
Age range 65 to 75 years
No participation in physical activity six months before the intervention
Ability to walk independently using TUG and 25FW tests Absence of cardiovascular and respiratory diseases
Absence of any orthopedic issues in the lower body
Intervention groups
High-intensity interval training group with Q10 supplement
High-intensity interval training group with a placebo (control group)
Main outcome variables
Assessing the effectiveness of antioxidant supplement Q10 consumption along with high-intensity interval exercises on overall health in elderly individuals. How using the antioxidant supplement Q10 can improve metabolic status and reduce chronic inflammation in the elderly.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240310061243N1
Registration date:2024-07-25, 1403/05/04
Registration timing:prospective
Last update:2024-07-25, 1403/05/04
Update count:0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
Navid Bagheri
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3450 8743
Email address
navid.bagheri@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high-intensity interval training and coQ10 supplementation on some physiological markers and inflammatory markers in older adults
Public title
The Effects of Exercise Training with supplementation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to walk independently based on Timed Up and Go (TUG) tests and 25-foot walk
Age range of 65 to 75 years
Non-participation in sports programs from 6 months before intervention
Exclusion criteria:
Consumption of any dietary supplement other than the specified supplement
Having any orthopedic issues in the lower body
Prohibition from participating in sports activities by a doctor
Suffering from cardiovascular and respiratory diseases
Age
From 65 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple and the randomization unit is individual and will be divided into two random groups using Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and outcome assessors in this research will not be aware of the grouping method and research objectives (exercise intervention with supplements or intervention with placebo). Participants will be aware that they will be participating in a research project, but they will not be aware of the researcher's goals.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee at Isfahan University Research Department
Street address
Room 325, 3rd Floor, Main Building, Isfahan University
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.UI.REC.1403.018
Health conditions studied
1
Description of health condition studied
Ageing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Antioxidant status
Timepoint
Before starting and after the end of the intervention (pretest and post-test)
Method of measurement
Glutathione peroxidase, superoxide dismutase, malondialdehyde, total antioxidant capacity research kits
2
Description
CRP as an inflammatory marker
Timepoint
Before starting and after the end of the intervention
Method of measurement
Quantitative CRP Diagnostic Kit
3
Description
liver enzymes ALT and AST
Timepoint
Before starting and after the end of the intervention
Method of measurement
Diagnostic kit
4
Description
Body fat percentage and lean body mass
Timepoint
Before starting and after the end of the intervention
Method of measurement
Body composition
5
Description
Physical performance (balance, walking speed, aerobic capacity, lower and upper body strength)
Timepoint
Before starting and after the end of the intervention
Method of measurement
Timed Up and Go test, 25-foot walking, 10-meter walking, 6 min walk test, chair stand test, Astrand Cycle Ergometer Test, Hand grip.
Secondary outcomes
1
Description
sleep quality
Timepoint
Before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Quality of Life
Timepoint
Before and after the intervention
Method of measurement
Older People's Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: High-intensity interval training with Q10 supplementation
Category
Prevention
2
Description
Control group: High-intensity interval training with a placebo consumption
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Isfahan
Full name of responsible person
Mehdi Kargarfard
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 4282
Email
m.kargarfard@spr.ui.ac.ir
Web page address
https://spr.ui.ac.ir/~m.kargarfard
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mehdi Karagr fard
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
info@ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Isfahan
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
The University of Isfahan
Full name of responsible person
Mehdi Kargar Fard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 4282
Email
kargar_m46@yahoo.com
Web page address
https://spr.ui.ac.ir/~m.kargarfard
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mehdi Kargar Fard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 4282
Fax
+98 31 3793 4282
Email
kargar_m46@yahoo.com
Web page address
https://spr.ui.ac.ir/~m.kargarfard
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Navid Bagheri
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8169713456
Phone
+98 31 3450 8743
Email
nbagheri@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
Not applicable
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