The effect of 8 weeks of combined exercises with and without blood flow restriction and vitamin D intake on serum levels of alkaline phosphatase and C reactive exercise (crp) and muscle quality of elderly women.
Determining the effect of 8 weeks of combined exercises with and without blood flow restriction and vitamin D supplementation on the serum levels of alkaline phosphatase and C-reactive protein (CRP) and muscle quality of elderly women.
Design
Clinical trial with control group, with parallel groups, randomized, on 40 elderly people. Randomization by the method of equal blocks (10 blocks of 4) in which a number of intervention people and a number of comparison people are included in each block.
Settings and conduct
By referring to the rehabilitation and physiotherapy clinic, eligible people were identified and placed in the intervention groups using equal blocks (10 blocks of 4) randomization. Then, people will go to the sports club for training intervention and perform exercises and supplements for 8 weeks. And before and 24 hours after exercise interventions, blood samples are taken from people to be measured in the laboratory.
Participants/Inclusion and exclusion criteria
Entry requirements: Age range between 65 and 75 years
Conditions of non-entry: inability to do exercises
Intervention groups
Group of combined exercises and supplements: in the group of combined exercises, the samples perform exercises with blood flow restriction (BFR) and without blood flow restriction, and the supplement group takes vitamin D supplements, and the control group does not undergo any intervention.
Main outcome variables
serum levels of alkaline phosphatase and reactive protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221120056548N5
Registration date:2023-03-01, 1401/12/10
Registration timing:registered_while_recruiting
Last update:2023-03-01, 1401/12/10
Update count:0
Registration date
2023-03-01, 1401/12/10
Registrant information
Name
Saeid Shamlou kazemi
Name of organization / entity
Bu-Ali Sina university
Country
Iran (Islamic Republic of)
Phone
+98 912 859 7297
Email address
saeidshamlou9092@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-28, 1401/12/09
Expected recruitment end date
2023-03-29, 1402/01/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of combined exercises with and without blood flow restriction and vitamin D intake on serum levels of alkaline phosphatase and C reactive exercise (crp) and muscle quality of elderly women.
Public title
Effect of exercise, vitamin D supplementation on serum levels of alkaline phosphatase and reactive protein(crp)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
elderly
Exclusion criteria:
History of cardiovascular disease
Age
From 65 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
By referring to the rehabilitation and physiotherapy clinic, eligible people were identified and placed in the intervention groups using equal blocks (10 blocks of 4) randomization. In this randomization, the method of equal blocks (10 blocks of 4) was used, in which a number of intervention people and a number of comparison people are included in each block, and we assigned them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sports Science Research Institute
Street address
Fifth Alley, Mir Emad Ave., Ostad Motahari Ave
City
Tehran
Province
Tehran
Postal code
1474674646
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.SSRI.REC.1401.1583
Health conditions studied
1
Description of health condition studied
Elderly
ICD-10 code
O09.52
ICD-10 code description
elderly
Primary outcomes
1
Description
The percentage of elderly people in the community with improvement of alkaline phosphatase level
Timepoint
Measurement of alkaline phosphatase levels before and after the intervention
Method of measurement
ALP bone isozyme test
2
Description
The percentage of elderly people in the community with decreased levels of reactive protein
Timepoint
Measurement of reactive protein levels before and after the intervention
Method of measurement
By testing blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combined exercises (aerobic-resistance) of an 8-week program will include three training sessions per week and about one hour per day. Before starting the exercise, the subjects warm up for 10 minutes with stretching and stretching movements, and at the end of the exercise, they cool down with stretching movements for 10 minutes. Resistance exercises include two lower body movements (leg press, knee extension) and two upper body movements (front arm, back arm). Leg, front thigh, front arm and back arm press movements with intensity (80% of one maximum repetition) three sets with 8-12 repetitions for the first group and intensity of 20-30% of one maximum repetition (three sets until exhaustion) for groups The second and third work is done with weights. In the subjects of the third group, blood flow restriction is done by closing the elastic bands in the proximal part of both legs during lower body exercises or both arms during upper body exercises. In the supplement group, vitamin D supplement in the form of 50,000 mg capsules will be used once every two weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Vahedi Physical Medicine and Rehabilitation Center
Full name of responsible person
Saeid shamlou kazemi
Street address
Jahan Shahr Ave, Ostandari Ave
City
کرج
Province
Tehran
Postal code
3149915968
Phone
+98 26 3444 9975
Email
saeidshamlou9092@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Danesh Alborz University
Full name of responsible person
Saeid Shamlou Kazemi
Street address
MAhdiywh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Danesh Alborz University
Proportion provided by this source
10
Public or private sector
Private
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
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh AVE
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu-Ali Sina university
Full name of responsible person
Saeid Shamlou kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Fax
Email
saeidshamlou9092@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh AVE
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.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
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If the intellectual rights are preserved, the data can be sent to the researchers.
From where data/document is obtainable
Email address: saeidshamlou9092@gmail.com
What processes are involved for a request to access data/document