1. Home
  2. Approved trials
  3. » فارسی

The effect of balance exercises on sleep quality in patients with heart failure

Protocol summary

Study aim
to determine the effect of balance exercises on the quality of sleep of patients with heart failure
Design
A randomized clinical trial on 55 patients
Settings and conduct
Heshmatieh Sabzevar Hospital Cardiopulmonary rehabilitation department. The questionnaire divides patients into two groups with good sleep quality and poor sleep quality. Then, using the random assignment method and R software, and using 4 permutation blocks, we divide the patients who have poor sleep quality into two intervention and control groups. Then the intervention group is taught balance exercises.The total duration training will be four times a week for eight weeks At the end of this familiarization session,. They are asked to do exercises at home 2-3 hours before sleeping at night. After two months of the intervention, the sleep quality questionnaire is again given to the control and intervention groups and their sleep quality is evaluated.
Participants/Inclusion and exclusion criteria
Entry criteria: at least one month has passed since their heart failure diagnosis, being in the 1st, 2nd and 3rd class of heart failure. suffering from sleep disorders, interested in participating in the study and having full consciousness. Non-entry criteria: patients with severe insufficiency who are in grade 4, patients with movement and physical limitations, patients with joint and skeletal diseases, patients diagnosed with respiratory apnea, patients who are willing Patients who suffer from deterioration of their physical condition and intolerance during the study and symptoms such as shortness of breath, dizziness, extreme fatigue, etc
Intervention groups
We teach the intervention group balance exercises, they do them for 2 months, and then we measure their sleep quality. In the control group we only measure their sleep quality after 2 months.
Main outcome variables
Balance exercises, sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230725058925N1
Registration date: 2023-08-09, 1402/05/18
Registration timing: registered_while_recruiting

Last update: 2023-08-09, 1402/05/18
Update count: 0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Hossein Motamedi manesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3341 9158
Email address
hoseinpars817@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2023-10-02, 1402/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of balance exercises on sleep quality in patients with heart failure
Public title
The effect of balance exercises on sleep quality in patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least one month has passed since their heart failure diagnosis being in class 1, 2 and 3 of heart failure EF≥40 suffering from sleep disorders interested in participating in the study having full consciousness
Exclusion criteria:
Patients with severe insufficiency who are in grade 4 patients with movement and physical limitations patients with joint and skeletal diseases patients diagnosed with respiratory apnea patients unable to complete the questionnaire patients who did not want to participate in the study Patients who experience worsening physical condition and intolerance and symptoms such as shortness of breath, dizziness, severe fatigue, etc. during the study patients who die during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the criteria for entering the study are selected and interviewed in person to participate in the research if they wish. Then the questionnaire is distributed among the patients and the patients are requested to complete the questionnaires in person and the confidentiality of their information is explained to the patients and if the patients wish, they will be informed of the research results. The questionnaire divides patients into two groups with good sleep quality and poor sleep quality. Regarding the study, sufficient explanations will be given to patients with poor sleep quality, and then consent forms will be given to these patients and these forms will be completed in person by the patients. Then, using the random allocation method and R software, and using 4 permutation blocks, we divide the patients who have poor sleep quality into two intervention and control groups
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 Sabzevar University of Medical Sciences
Street address
Shahrak Tawheed Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Approval date
2023-07-26, 1402/05/04
Ethics committee reference number
IR.MEDSAB.REC.1402.058

Health conditions studied

1

Description of health condition studied
heart failure
ICD-10 code
150
ICD-10 code description
complicating:abortion or ectopic or molar pregnancy (O00-O07, O08.8)obstetric surgery and procedures (O75.4)due to hypertension (I11.0)with renal disease (I13.-)following cardiac surgery or due to presence of cardiac prosthesis (I97.1)neonatal cardiac fai

Primary outcomes

1

Description
sleep quality
Timepoint
The beginning of the study. end of study
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before the intervention, the sleep quality questionnaire is taken from the intervention group. Then balance exercises are taught to the patients. The exercise program is given to them. 2 months later, the sleep quality questionnaire will be taken from them and compared.
Category
Rehabilitation

2

Description
Control group: The sleep quality questionnaire is taken from the patients, and then 2 months later, this work is repeated and the primary and secondary results are compared.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmatieh Sabzevar Hospital
Full name of responsible person
Hamid Marefai
Street address
Asadabadi St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1600
Email
hh.medsab.ac.ir@domain.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Kazem Hasanpour
Street address
Shahrak Tawheed Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 8440
Fax
+98 51 4401 8424
Email
info@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mustafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrak Tawheed Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8352
Email
radmostafa633@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mustafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrak Tawheed Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8352
Email
radmostafa633@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mustafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrak Tawheed Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8352
Email
radmostafa633@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study will be reported to the patients if they wish
When the data will become available and for how long
Access starts 6 months after the announcement of the results
To whom data/document is available
Academic staff
Under which criteria data/document could be used
For more research
From where data/document is obtainable
Dr. Mustafa Rad 09159720970 radmostafa633@gmail.com Hossein Motamedi mansesh 09024189917 hoseinpars817@gmail.com
What processes are involved for a request to access data/document
Requests should be sent to hoseinpars817@gmail.com. The request will be reviewed. Your answer will be sent by email
Comments
Loading...