Protocol summary

Study aim
This study aims to improve the motor skills and the executive functions like thinking reasoning , problem solving and memory of the older individuals using a specific form of exercises. tai chi exercises enhance self awareness and at the same time relaxes body and helps to gain a good balance , stability and aligned posture.it also shows potential to improve the cognitive functioning
Design
Randomized control trial, community based, single blind, allocated randomly through sealed envelope method into 2 groups.
Settings and conduct
The study will be conducted in the Al-Najat old home. • Participants will be included in the study after taking full informed consent. • Participants will be screened thoroughly for any exclusion, before getting enrolled. • Participants will be determined by the Single Leg Stance test to include in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) males and females of age 60 years and above. 2) individuals with Single leg stance score less than 20 seconds. Exclusion criteria: 1) color blind individuals. 2) visually impaired individuals. 3) bed bound individuals.
Intervention groups
The intervention group will be performing different tai chi moves for 6 consecutive weeks for a number of 5 days in a week, in which there will be a 10 min warm up session, 40 mins exercise session and 10 mins of cool down session.
Main outcome variables
Executive function and motor skills

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210615051585N6
Registration date: 2023-04-29, 1402/02/09
Registration timing: registered_while_recruiting

Last update: 2023-04-29, 1402/02/09
Update count: 0
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
Saima Gul
Name of organization / entity
Shifa Tameer - e - Millat University
Country
Pakistan
Phone
+92 51 8441751
Email address
saimagul.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-12, 1402/01/23
Expected recruitment end date
2023-05-26, 1402/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tai chi intervention for improving motor skills and executive function in older adults
Public title
Effect of tai chi intervention for improving motor skills and executive function in older adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male and female of 60 years and above single leg stance score less than 20 seconds
Exclusion criteria:
color blind individuals bed bound individuals visually impaired individuals
Age
From 60 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 77
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment using the sealed envelope method will use. According to the sample size, 70 sheets of aluminum paper will be cut properly. This paper will be double the size of the paper. 35 sheets of carbon paper cut into appropriate sizes according to the paper used. A standard-sized square paper will take and mark with (the Tai chi group). In this way, 35 papers will mark with (Control group ). The sheet of paper on which either the tai chi group or the control group will mention will then be folded to fit in the envelope. A sheet of carbon paper will place on top of the folded paper and mark either the tai chi group or the control group facing the envelope, then the sheet of aluminum foil will be wrapped on the carbon paper( with folded paper inside). All the above-prepared papers will place in the envelope (which will utterly opaque) the envelope will then be sealed. in this way, 35 envelopes for the tai chi group and 35 envelopes for the control group will prepare with a total number of 70. These envelopes will then thoroughly shuffle like a deck of cards. The envelopes will then mark with numbers 1-70. Each participant picks the envelope in order from 1-70 and will be allotted to the group( tai chi group or control group) accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher doing the study knows which treatment or intervention the participant is receiving until the intervention is complete. It makes results less likely to be biased. For that, People receiving treatment will engage to the same extent, also, therapist who will deliver treatment do so with the same effort and enthusiasm, regardless of whether they are delivering treatment or a control.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
institutional review board and ethics committee of shifa international hospital
Street address
shifa international hosptial, pitrus bukhari road, h-8, islamabad.
City
Islamabad
Postal code
44000
Approval date
2023-04-04, 1402/01/15
Ethics committee reference number
015-23

Health conditions studied

1

Description of health condition studied
Old age
ICD-10 code
R54
ICD-10 code description
Age-related physical debility

Primary outcomes

1

Description
Motor skills and executive functions
Timepoint
Before intervention and 6 weeks after intervention.
Method of measurement
Time up and go test, stroop test, trail making test.

Secondary outcomes

1

Description
Balance, activities of daily living
Timepoint
Baseline and after intervention
Method of measurement
Single leg stance test, barthel index

Intervention groups

1

Description
Intervention group: For this group, a series of tai chi exercises will be carried out in smooth pattern. Doing Tai chi exercises in a specific pattern will improve individuals ability to perform coordinated activities, body awareness, mental focus and flexibility. Each training session consist of a 10-minute warm-up, 40 minutes practicing basic Tai Chi forms, and a 10-minute cool-down. These session will last for 6 consecutive weeks for a number of 5 days per week.
Category
Rehabilitation

2

Description
Control group: this group will receive a basic protocol of 60 minutes involving 10 minutes warms up 10 minutes of static stretching of major muscle groups , 40 minute aerobic exercises and 10 minutes cool down. These sessions will be given for 6 weeks consecutively for 5 days per week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Najjat old homes
Full name of responsible person
Azhar Tanveer Malik
Street address
Saidpur rd, near Muslim Higher School, Asghar mall scheme, Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 4411111
Email
saherfatmimspt21@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Street address
Department of Rehabilitation Sciences, Park Rd campus Chak shahzad, Islamabad
City
Islamabad
Postal code
44000
Phone
+92 51 8441751
Fax
+92 51 8441751
Email
Saimagul.ahs@stmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shifa Tameer e Millat 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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Park Rd campus Chak shahzad, Islamabad
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 8441751
Fax
+92 51 8441751
Email
Saimagul.ahs@stmu.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Park Rd campus Chak shahzad, Islamabad
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 8441751
Email
Saimagul.ahs@stmu.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Park Rd campus Chak shahzad, Islamabad
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 8441751
Email
Saimagul.ahs@stmu.edu.pk

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
Due to ethical considerations
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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