Effect of Tai-Chi Chuan exercise on balance status of elderly men in Kashan in 2020
Design
Clinical trial with control group, no parallel group, without blinding, randomized, sample size 40
Settings and conduct
This study will be performed on 40 elderly people in Kashan`s Akramian Clinic in 2020. After selecting the samples according to the inclusion criteria and dividing them into two control and intervention groups, the intervention group will receive Tai-Chi exercises within 10 weeks.
Participants/Inclusion and exclusion criteria
inclusion criteria: The elderly over 60; Able to do Tai Chi exercise; Unexplained stroke; Unrecognized hearing and visual impairment; Resident of Kashan; Elderly not participating in similar studies; Willingness to cooperate; Lack of physical disability; Score below 25 from Fullerton Tool؛ No sleeping medication daily
exclusion criteria: Withdrawal from attendance; Absence of more than two sessions; Election; Hospitalization; Acute and severe physical illness during study; Prescription of persistent sleep medications
Intervention groups
Intervention group: The group that will practice Tai Chi Chuan 2 sessions per week for 10 weeks.
Control group: The control group will not receive any intervention from the research team.
Main outcome variables
The main outcome variable is improvement in the balance of the elderly. The researcher will use the Fullerton tool to assess the balance state. The checklist has 10 items that are assigned 0 to 4 points per item. The score from this checklist will be between zero and forty and the cut-off point for this balance will be 25.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200108046058N1
Registration date:2020-02-02, 1398/11/13
Registration timing:registered_while_recruiting
Last update:2020-02-02, 1398/11/13
Update count:0
Registration date
2020-02-02, 1398/11/13
Registrant information
Name
Hamid gholami alavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5522 3010
Email address
gholami-h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The surveying of effect of tai-chi chuan exercise on the balance status of the elderly men
Public title
The surveying of effect of tai-chi chuan on the balance status
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
elderly men over 60 years
Be able to do Tai Chi exercise
Not having a history of brain stroke and other diseases that affect balance
Lack of corrected visual and hearing impairment
Resident of Kashan
Elderly not participating in similar studies
Willingness to cooperate
Lack of physical disability
Earn a score below 25 from the Fullerton scale
Patients who do not take sleeping pills daily
Exclusion criteria:
Withdraw from attendance
Absent more than 2 sessions of workouts
Hospitalization
Acute and severe physical illnesses during the study
Prescription of permanent hypnotic medications
Age
From 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected from the clients according to the inclusion criteria in an accessible and easy manner and then randomly assigned to the experimental and control groups And a written consent is obtained from them. In addition, random allocation of the elderly to the two groups of experimental and control will be done using quadruple random blocks method. (The first 6 blocks are assigned and numbered 1 to 6. Subsequently these blocks plus duplicates of blocks 1 to 4 Regularly stacked together to achieve 10 blocks <40 cases>)
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 Kashan University of Medical Sciences
Street address
ayatollah yasrebi street، Alley of Martyr Podat, No. 12
City
kashan
Province
Isfehan
Postal code
8716863856
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.056
Health conditions studied
1
Description of health condition studied
tai-chi chuan exercise
ICD-10 code
ICD-10 code description
2
Description of health condition studied
balance status
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people with a Fullerton instrument score above 25
Timepoint
Measurement of balance status at baseline (before intervention) and end of study
Method of measurement
Fullerton Advanced Balance Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During a briefing session, research tips for the elderly in the intervention group will be described. After pre-test for all participants, the intervention group in a group under the supervision of a specialist instructor and researcher will do selected Tai Chi Kung exercises (Tai Chi Chuan exercise is a type of traditional Chinese exercise that involves physical activity and cognitive control, performed individually or in groups.The principles of Tai Chi Kung include soft and slow movements and special attention to relaxation) for 10 weeks, 2 sessions per week and 30-40 minutes each session in Kashan akramian Clinic. Each exercise session consists of 5 minutes of warm-up, 20 minutes of Tai Chi exercises and 5 minutes of cool-down. Every workout session in elementary program sessions is 30 minutes and the final sessions will increase to 40 minutes.
Category
Rehabilitation
2
Description
Control group: The control group will not receive any intervention from the research team.