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The effects of hand exercises program on cognitive function and activities of daily living in people 60 years and older

Protocol summary

Summary
Objectives: The purpose of this study is to evaluate the effects of hand exercises program on cognitive function and activities of daily living in people 60 years and older. Design: Participants are selected from healthy elderly men and women, aged 60 and elders, in elderly care centers. 20 participants are randomly assigned into control or intervention group by coded envelop. Setting and conduct: Evaluations are done four times before and after the intervention, three weeks after intervention and a month after intervention by a trained Occupational Therapist who is blind to type of group. Participants: Subjects must have Cognitive, Vision, Hearing, Cardiovascular, Orthopedic, Rheumatologic and Neurological health and can read and write in Persian. Intervention: After the baseline assessments, treatment sessions are given, 3 sessions per week, each session about 60 minutes for 6 weeks. Each session of Treatment includes: Resistive exercise with Putty for hand muscles (Thenar and Hypothenar) and dexterity exercises based on Activities of Daily Living, such as writing, open and close button,....Main outcome measures: Barthel-Index Assessment Test is performed to determine ability level in activities of daily living and Stroop test and Wechsler scale are done for cognitive function.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608213551N3
Registration date: 2016-08-28, 1395/06/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Parvin Raji
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 8798
Email address
praji@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education,Tehran University of Medical Sciences
Expected recruitment start date
2015-09-30, 1394/07/08
Expected recruitment end date
2016-09-30, 1395/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of hand exercises program on cognitive function and activities of daily living in people 60 years and older
Public title
The effects of hand exercises program on cognitive function and activities of daily living in people 60 years and older: A Randomized Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Seniors 60 years and older interested in participating in the study (informed consent); Lack of vision and hearing problems; MMSE score higher than 21; Minimum level of education to Fifth-grade; Ability to communicate and answer questions in Persian; Lack of Cardiovascular disease; Lack of acute Orthopedic problems, Neurological and Rheumatological disorder that leads to conflict and pain in the upper extremity; Lack of depression and anxiety disorders based on medical records. Exclusion criteria: Lack of cooperation and willingness to withdraw subjects during sessions assessment and intervention
Age
From 60 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
There is not
Secondary trial Id
There is not
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina St, Ghods St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-01-13, 1394/10/23
Ethics committee reference number
IR.TUMS.REC.1394.1645

Health conditions studied

1

Description of health condition studied
people 60 years and older
ICD-10 code
M62.5
ICD-10 code description
Muscle wasting and atrophy, not elsewhere classified Disuse atrophy NEC

Primary outcomes

1

Description
Activities of daily living
Timepoint
before intervention, three weeks after intervention, after intervention, A month after intervention
Method of measurement
Barthel Index

Secondary outcomes

1

Description
cognitive function
Timepoint
before intervention, three weeks after intervention, after intervention, a month after intervention
Method of measurement
Stroop test, Wechsler scale

Intervention groups

1

Description
Intervention 1: Dexterity exercises for hand muscles based on Activities of Daily Living
Category
Rehabilitation

2

Description
Intervention 2: Traditional occupational therapy interventions
Category
Rehabilitation

3

Description
Intervention1: Resistive exercises for hand muscles with putty
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for education,Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for education,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
lecturer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
praji@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
lecturer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
praji@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
lecturer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
praji@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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