Evaluation the effect of the eight week of dual task training with and without blood flow restriction on functional factors and quality of life of elderly women: a clinical trial
The main objective of this study is to investigate the effect of dual task training with and without blood flow restriction on functional factors (static and dynamic balance, fear of falling, pain, getting up and going) and quality of life in elderly women.
Design
A randomized clinical trial study, single blind, parallel groups, 45 participants will be divided into two intervention groups and one control group, randomization will be done through web randomization.
Settings and conduct
The place of study (Barman Sports Club) was in Shariati area of Tehran
The statistical population was 45 people.
This is a blinded study where the evaluators are blinded to the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: having the necessary alertness; verbal ability and answering the desired questions; age range of 60-70 years; having physical and mental health; having regular sports practice; Signed informed consent to participate in the study
Exclusion criteria: existence of mental problems; intellectual disability; injury and history of joint replacement in the lower limb; history of balance disorder and frequent dizziness
Intervention groups
Intervention group 1: group of resistance exercise and cognitive task with blood flow restriction;
Intervention group 2: group of resistance exercise and cognitive task without blood flow restriction;
Control group: The control group did not have any training
Main outcome variables
Static balance; dynamic balance; quality of life; sitting and standing time; Pain; fear of falling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240913063022N1
Registration date:2025-03-17, 1403/12/27
Registration timing:prospective
Last update:2025-03-17, 1403/12/27
Update count:0
Registration date
2025-03-17, 1403/12/27
Registrant information
Name
Mohadeseh Talebi tamajani
Name of organization / entity
The University of alzahra
Country
Iran (Islamic Republic of)
Phone
+98 21 6628 7595
Email address
mh.talebi1378@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-03, 1404/01/14
Expected recruitment end date
2025-06-19, 1404/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of the eight week of dual task training with and without blood flow restriction on functional factors and quality of life of elderly women: a clinical trial
Public title
The effect of the eighth week of exercise on comparison and fear of falling and the quality of life of healthy women
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Having the necessary vigilance
Having verbal ability and answer the desired questions
Age range of 60 to 70 years
Having mental health and physical health
Participate in a regular exercise program
Signed informed consent to participate in the study
Exclusion criteria:
The existence of mental problems
Mental disability
Injury and history of joint replacement in the lower limb
History of balance disorder and frequent dizziness
Age
From 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
By simple random sampling individually with the help of a web program (randomizer.org), they are assigned to two intervention groups and one control group. A member of the research team not involved in the selection of samples will determine the sequence of random allocation using a computer program. Randomly sequenced opaque sealed envelopes will be used to conceal the allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome evaluator is blind, so that he does not know how the subjects are assigned to the groups and what treatment intervention each group of subjects will receive. In this way, during the evaluation before and after the protocol period, they do not make mistakes in their judgments in favor of a specific therapeutic intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Al-Zahra University
Street address
Al-Zahra University, Deh-e-Vanak, Vanak
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Approval date
2024-05-31, 1403/03/11
Ethics committee reference number
IR.ALZAHRA.REC.1403.018
Health conditions studied
1
Description of health condition studied
Sarcopenia
ICD-10 code
M62.89
ICD-10 code description
Other specified disorders of muscle
Primary outcomes
1
Description
Static balance
Timepoint
The first day and the last day after eight weeks of training
Method of measurement
Balance test with eyes closed
2
Description
Dynamic balance
Timepoint
The first day and the last day after the end of eight weeks of training
Method of measurement
Leaf test
3
Description
Fear of falling
Timepoint
The first day and the last day after the end of eight weeks of training
Method of measurement
Fear of falling questionnaire
4
Description
Pain
Timepoint
The first day and the last day after the end of eight weeks of training
Method of measurement
Chronic Pain Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
The first and last day after the end of eight weeks of training
Method of measurement
Lipad questionnaire
Intervention groups
1
Description
The first intervention group: the group of resistance training and cognitive task training with blood flow restriction, this group had a training program of 3 sessions a week. For eight weeks, AOP pressure (blood flow obstruction) was calculated and 5% was added to it every week. Their training programs were also calculated with 1RM weight, because they both had AOP pressure, and the weight of half of the calculated 1RM was applied and 5% was added to the intensity every week.
Category
N/A
2
Description
The second intervention group: resistance training group and cognitive task training without blood flow restriction, this group also trained three sessions a week for 8 weeks. Resistance training was calculated with 1RM weight and 5% was added to the intensity every week.
Category
N/A
3
Description
The third group: The control group did not have any training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Saray-e-Mahalleh
Full name of responsible person
Elham Shakor
Street address
Al-Zahra University, Deh-e-Vanak, Vanak
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8804 4040
Email
eli-shakoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Al-Zahra University
Full name of responsible person
Zahra Jafarzadeh
Street address
Al-Zahra University, Deh-e-Vanak, Vanak
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8804 4040
Email
eli_shakoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Al-Zahra University
Proportion provided by this source
100
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Al-Zahra University
Full name of responsible person
Rosa Rahavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Movement behavior
Street address
Al-Zahra University, Deh-e-Vanak, Vanak
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8804 4040
Email
R.Rahavi@alzahra.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Al-Zahra University
Full name of responsible person
Mohadeseh talebi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Sports science
Street address
Al-Zahra University, Deh-e-Vanak, Vanak
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
009866287595
Email
Mh.talebi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Al-Zahra University
Full name of responsible person
Mohadeseh Talebi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Sports science
Street address
Al-Zahra University, Deh-e-Vanak, Vanak
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
009888044040
Email
Mh.talebi1378@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