This study is a double-blind randomized clinical trial. Inclusion criteria: patients with stage 3 or 4 COPD (according to the GOLD system ; Having degrees of moderate to severe fatigue and sleep disturbance based on questionnaire of fatigue and sleep quality index;
Exclusion criteria: cognitive disorders; viral infections; participation in pulmonary rehabilitation
Sample size is 100 patients who are assigned into two intervention and control groups (each 50 person). Subjects will be selected using probability random sampling method. In pre-test, data is collected using self-report responses to questionnaire of sleep quality PSQI and questionnaire of fatigue index FSS . Then for patients in the intervention group Progressive muscle relaxation program will be performed. Steps of progressive relaxation exercises include Breathing Exercises، lower extremity exercises ،upper extremity exercises and exercise of respiratory muscles .In the post-test stage, 8 weeks after the completion of their education, patients will be asked to come to the Lung clinic and complete the FSS and PSQI by the researcher. Also in the control group they will receive usual care and ate the end of 8 weeks questionnaire of sleep quality PSQI and questionnaire of fatigue index FSS Will be completed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080124080N3
Registration date:2017-03-11, 1395/12/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-11, 1395/12/21
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Progressive Muscle Relaxation Technique of Fatigue and Quality of Sleep in Pations with Chronic Obstructive Pulmonary Disease
Public title
Effect of Progressive Muscle Relaxation Technique of Fatigue and Quality of Sleep in Pations
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria includ: COPD Diagnosed by a physician of at least duration of 6 months or longer; residence in the city; patients with stage 3 or 4 COPD (according to the GOLD system, 2007); absence of a disease diagnosis additional to COPD; ability to read and write and willingness to collaborate ; Having degrees of moderate to severe fatigue and sleep disturbance; based on questionnaire of fatigue and sleep quality index; The absence of disease of the nervous system ، Acute myocardial Infarction And Cancer In addition to copd; Age 45 to 70 years،BMI less than 30 ; Lack of psychiatric disorders such as anxiety .
The exclusion criteria include: cognitive disorders;viral infections; participation in pulmonary rehabilitation
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Lorestan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kamalvand, Campus of Lorestan University of Medical Sciences.
Immediately before intervention and 8 week after intervention
Method of measurement
Fatigue severity scale(fss)
Secondary outcomes
1
Description
Quality of sleep
Timepoint
Immediately before intervention and 8 week after intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Intervention groups
1
Description
for patients in the intervention group will perform Progressive muscle relaxation program.steps of progressive relaxation exercises include Breathing Exercises، lower extremity exercises ،upper extremity exercises and exercise of respiratory muscles
- PMRT will give by using a handbook including relaxation exercises (including information about how to perform relaxation, respiration control, and progressive relaxation exercises) and a PMRT CD (educational CD prepared by the Iranian Association of Psychologists). After the education, each patient will give a handbook and CD containing PMRT and will ask to listen to and perform the exercises at home by following the instructions in the CD once a day for 8 weeks at hours when they feel themselves the least tired .
Category
Rehabilitation
2
Description
Also in the control group they will receive usual care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences
Full name of responsible person
Pouya Seydi Chegeni
Street address
School of Nursing and Midwifery, Kamalvand, Campus of Lorestan University of Medical Sciences.
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Research Department
Street address
Kamalvand , Technology Research Department of Lorestan University Of Medical Sciences.
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University Of Medical Sciences
Full name of responsible person
Pooya.Seydi Chegeni
Position
Undergraduated Student
Other areas of specialty/work
Street address
School Of Nursing and Midwifery, Kamalvand, Lorestan University Of Medical Sciences .
City
Khoramabad
Postal code
6814993165
Phone
+98 66 3314 0120
Fax
Email
pooya.seyedi22@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
Phd
Other areas of specialty/work
Street address
School Of Nursing and Midwifery, Kamalvand, Lorestan University of Medical Sciences .
City
Khoramabad
Postal code
6814993165
Phone
+98 66 3312 0140
Fax
Email
mohammad13565@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Pooya Seydi Chgeni
Position
Undergraduated Student
Other areas of specialty/work
Street address
School Of Nursing and Midwifery, Kamalvand, Lorestan University Of Medical Sciences .
City
Khorramabad
Postal code
6814993165
Phone
+98 66 3314 0120
Fax
Email
pooya.seyedi22@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)