Determining the effect of a planned walk based on a mobile phone on the quality of sleep of the elderly hospitalized in Rasht Shafa Hospital
Design
A controlled, parallel-group, unblinded randomized clinical trial on 62 patients. Sealed Envelope Ltd online randomization service is used for randomization.
Settings and conduct
The research environment is Shafa Mental Hospital in Rasht and the research population will be all elderly people aged 60 years and older hospitalized in the mentioned hospital who suffer from mild to moderate depression. This study is a randomized clinical trial, which is conducted in the form of available sampling. In this way, all eligible elderly will be divided equally (1:1 ratio) into intervention and control groups using the block randomization method with the size of blocks of 4 and 6.
Participants/Inclusion and exclusion criteria
Inclusion criteria: elderly 60 years and older; having a doctor's permission to walk; not suffering from cognitive disorders such as delirium and dementia; suffering from bipolar disorder; Obtaining a score of 5 or higher on the Pittsburgh Sleep Quality Scale (PSQI) and exclusion criteria: severe vision and hearing disorders; history of falling in the last year; use assistance when walking.
Intervention groups
The control group received the usual psychiatric treatments prescribed by the attending physician. In the intervention group, in addition to the usual treatments 3 days a week for 4 weeks, 30 minutes of walking per day will be done based on the mobile phone-based walking evaluation program.
Main outcome variables
Sleep quality of the elderly
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190805044438N5
Registration date:2024-03-28, 1403/01/09
Registration timing:prospective
Last update:2024-03-28, 1403/01/09
Update count:0
Registration date
2024-03-28, 1403/01/09
Registrant information
Name
Roya Mansour-ghanaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4256 5058
Email address
r_ghanaei@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a planned walk based on a mobile phone-based on the sleep quality of hospitalized elderly: Randomized Clinical Trial
Public title
The effect of mobile phone-based planned walking on the sleep quality of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Elderly men and women 60 years and older
Having a doctor's permission to walk
Obtaining a score of 8 and above on the AMT cognitive scale
Not suffering from cognitive disorders such as delirium and dementia
Obtaining a score of 5 or higher on the Pittsburgh Sleep Quality Index (PSQI)
Exclusion criteria:
Suffering from severe vision and hearing disorders
History of falling in the last year
Use of assistance when walking
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the block method with the size of blocks of 4 and 6 equally (1:1 ratio) in the intervention and control groups. The method used to generate the random allocation sequence is Sealed Envelope Ltd. software. 2017 is available through the site www.sealedenvelope.com, which will be assigned to groups according to the order of the random list specified by the mentioned software. Individuals are entered into the random sequence by the researcher using an opaque sealed envelope with a random sequence.
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 Guilan University of Medical Sciences
Street address
Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
4477163485
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
IR.GUMS.REC.1402.593
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Sleep quality score using sleep quality measurement scale (PSQI)
Timepoint
Baseline data, after 4 weeks
Method of measurement
Pittsburgh Sleep Quality Scale (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the usual treatments, walking will be done in the air-conditioning area of the mental hospital. For the walking program, it will be used based on the mobile phone pedometer program called Step Tracker & Pedometer, which can be set in Farsi language, and the target number of steps can be determined in the program every day. This program will be installed on the researcher's mobile phone and will be used for every elderly person. In this program, the progress of the elderly can be evaluated in each session, and it will motivate the individual to increase the number of steps in the next session. Walking 3 times a week for 4 weeks, with an intensity that the patient's heart rate reaches more than 40-60% of the base rate. The duration of the walk will be 30 minutes (90 minutes per week), at the beginning and end of the walk, warming up and cooling down will be done for 5 minutes each with stretching movements. Walking will start at a low speed and gradually increase its speed until we reach the desired intensity. The heart rate of the elderly will be measured with a pulse oximetry device once before, once during and once at the end of the walk by placing it on the patient's index finger. By measuring the base pulse, we can reach the expected intensity, i.e. more than 40 to 60% of the base pulse. If the elderly person has not walked regularly, we will gradually increase the intensity and time of walking. The speed of the elderly person will be such that he can talk easily while walking. If necessary, the elderly will drink water before, during and after walking.
Category
Prevention
2
Description
Control group: During this period, they receive the usual psychiatric treatments that the attending physician has planned for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Mental Hospital
Full name of responsible person
Roya Mansour-ghanaei
Street address
Langeroud School of Nursing and Midwifery, Martyr Yaghoub Sheikhi St. leyla kooh, Langeroud, Guilan, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5059
Email
r_ghanaei@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramyar Farzan
Street address
Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
4477163485
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
r_ghanaei@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Primary outcome information is shared anonymously.
When the data will become available and for how long
Access started 6 months after the results were published.
To whom data/document is available
Research data can be provided for researchers working in the academic centers.
Under which criteria data/document could be used
Any use of data is depends on obtaining permission from the responsible author.
From where data/document is obtainable
The person responsible for the public accountability of the study can provide information to eligible individuals.
What processes are involved for a request to access data/document
If the person is eligible to request access to the documentation, it will be attempted to provide it as soon as possible after it has been demonstrated that the person is authorized to access the data. Roya Mansour-ghanaei, r_ghanaei@gums.ac.ir