The effect of exercise on symptoms of Insomnia in patients referred to sleep clinic
Design
A randomized, controlled, placebo-controlled clinical trial
Settings and conduct
The study is performed in the sports medicine department of Rasoul Akram Hospital. Patients are selected by randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People who meet Insomnia diagnostic criteria as specified by a psychiatrist;
People with systolic and diastolic blood pressure lower than 180 and 100, respectively;
People whose activity is less than 30 minutes a day;
People who have completed the study consent form.
Non-inclusion criteria:
People who have or have a history of cardiovascular disease;
People who have uncontrolled diabetes;
People who have uncontrolled respiratory disease;
Patients who are unable to exercise for any reason;
Patients whose symptoms of sleep disturbance strongly suggest other sleep disorders other than insomnia, such as sleep apnea and restless leg syndrome.
Intervention groups
Intervention group :Patients with insomnia , In this group, in addition to the medication prescribed for insomnia prescribed by the relevant psychiatrist, the intervention is performed for 3 months in the form of increased aerobic and resistance exercise. Aerobic exercise will be done in the form of walking three days a week, and dumbbell exercises are for large muscle groups and for three days a week.
Control group: Patients with insomnia , In this group, there is no intervention other than taking the prescribed medication for insomnia by the relevant psychiatrist.
Main outcome variables
Insomnia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100623004251N12
Registration date:2020-02-12, 1398/11/23
Registration timing:retrospective
Last update:2020-02-12, 1398/11/23
Update count:0
Registration date
2020-02-12, 1398/11/23
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
dadgostar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
2019-05-21, 1398/02/31
Actual recruitment end date
2019-11-30, 1398/09/09
Trial completion date
2019-11-30, 1398/09/09
Scientific title
Comparative study of drug therapy in combination with exercise and drug therapy alone in the treatment of patients with insomnia
Public title
The effect of exercise on insomnia in patients referred to sleep clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have diagnostic criteria for insomnia based on psychiatric examinations
People with systolic and diastolic blood pressure of less than 180 and 100, respectively
People with less than 30 minutes of activity per day
People who have completed the consent form of the study in the study
Exclusion criteria:
People with cardiovascular disease or history of cardiovascular disease
People with uncontrolled diabetes
People with uncontrolled respiratory illness
Patients who are not able to exercise for any reason
Patients whose symptoms of sleep disorder strongly suggest other sleep disturbances other than Insomnia, such as sleep apnea and restlessness syndrome
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization.
Four blocks of 4 including 2 participants in the intervention group and 2 participants in the control group were used. The blocks were selected by www.sealedenvelope.com.
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 Iran University of Medical Sciences
before intervention and 3 month after intervention
Method of measurement
Pittsburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Interventions are increased for 3 months in the form of aerobic and resistance exercise. Aerobic exercise will be performed in the form of walking, 30 minutes daily, three days a week in the first month, 45 minutes a day in the second month and 1 hour a day in the third month with moderate intensity. Twelve weeks of resistance training is considered .Every 4 weeks have same exercise program chosen from 3 models of A, B and C focusing on the large muscles of the lower and upper limbs and central part of the body that will be performed for 3 consecutive days per week. Before each session, patients warm up for 15 minutes with stretching exercises. Every two weeks the weight of the weight will be increased a half kilo so that the first week of every two weeks is three sets of 10, and the second week is three sets of 15, and the intensity increases gradually every two weeks. At the end of each session cooling down will be done for 5 to 10 minutes. The intervention group will be provided with a summary of these movements and their order through a booklet. The practitioner instructs patients on all movements during the first visit. Patients will record each movement after doing it in the report table given to them.
Category
Lifestyle
2
Description
Control group: patient with insomnia
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-e-Akram hospital
Full name of responsible person
Haleh Dadgostar
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
dadgostar.h@iums.ac.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevalian
Street address
Iran University of Medical Sciences,next to Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
motevalian@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgostar
Position
Associate professor , Iran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
dadgostar.h@iums.ac.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh dadgostar
Position
Associate professor , Iran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
dadgostar.h@iums.ac.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haheh dadgostar
Position
Associate professor , Iran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
dadgostar.h@iums.ac.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
Sleep quality data available in the pittsburgh questionnaire
When the data will become available and for how long
From the time the article was published until five years later
To whom data/document is available
Researchers working in academic centers who systematically intend to use these findings in meta-analysis.
Under which criteria data/document could be used
Due to the presence of the authors of this article in the academic center, there is a need to obtain written permission from the university to submit data. Therefore, after requesting data, this data will be sent within 6 months (after university approval).
From where data/document is obtainable
Rasoul Akram Hospital of Sports Medicine
Dr. Hale Dadgostar, Dr. Afsane Basharkhah
What processes are involved for a request to access data/document
Upon requesting documentation, the researcher must obtain a written permission from the research project and submit the documentation after obtaining permission. So the estimated time to send the data is about 6 months after their request.