Comparison of the effect of diaphragmatic and pursed-lip breathing exercises on sleep quality of older adults with chronic obstructive pulmonary disease
Determination and comparison of the effect of diaphragmatic and pursed-lip breathing exercises on sleep quality of older adults with chronic obstructive pulmonary disease
Design
Cross-over clinical trial without blinding
Settings and conduct
The research setting will include all public hospitals of Guilan province with lung / internal ward. Elderly people with inclusion criteria will be randomly divided into two intervention groups 1 and 2.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 60 and over; diagnosis of chronic obstructive pulmonary disease based on physician diagnosis; normal cognitive status; patients with low or moderate disease stage based on CAT ؛ Score 2 or lower from STOP-BANG Obstructive Sleep Apnea Questionnaire; Scores of 6 or more of the Pittsburgh Sleep Quality Index.
Non-entry criteria: unstable clinical condition; Inability to read and write Persian texts; History of participating in pulmonary rehabilitation programs; Taking sleeping and sedatives drugs; BMI above 35.
Intervention groups
Intervention group: In this intervention group breathing exercises will be performed. Intervention is a combination of diaphragmatic and pursed-lip breathing exercises that are performed after randomly dividing the subjects into intervention groups (1 and 2) using a Cross-over method. First, the intervention group will perform diaphragmatic breathing exercises for the first 4 weeks, and the second intervention group will have pursed-lip breathing exercises. After one week of wash out period, in the next 4 weeks of the study, the diaphragmatic breathing exercises and the pursed-lip breathing will be changed.
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190315043062N2
Registration date:2020-07-05, 1399/04/15
Registration timing:prospective
Last update:2020-07-05, 1399/04/15
Update count:0
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
Azar Darvishpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4256 5060
Email address
darvishpour@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of diaphragmatic and pursed-lip breathing exercises on sleep quality of older adults with chronic obstructive pulmonary disease
Public title
The Effect of Breathing Exercises on the Sleep Quality of Older Adults with Chronic Lung Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 and older
Diagnosis of chronic obstructive pulmonary disease based on the diagnosis of a physician
Obtain a score of 7 and above (natural cognition) from the AMTS Cognitive Status Questionnaire
Patients with low or moderate disease (score of 20 and below) based on CAT (CAT) test
Acquire 2 or lower (low risk) score on STOP-BANG Obstructive Sleep Apnea Questionnaire
Volunteering to participate in the study
Obtain a Score of 6 or more of the Pittsburgh Sleep Quality Index (having poor quality sleep)
Exclusion criteria:
unstable clinical condition (High and uncontrolled high blood pressure with or without medication, acute symptoms of congestive heart failure or coronary heart disease, another chronic illness that disrupts sleep, health problem that interferes with breathing exercise).
Inability to read and write Persian texts
History of participating in pulmonary rehabilitation programs
Taking sleeping and sedatives drugs
BMI above 35
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are divided into intervention groups (1 and 2) using random allocation method. First, the names of the treatment centers are written on separate sheets and then put in a packet and removed as one in the middle of the envelope and placed in intervention groups 1 and 2. (3 centers for intervention group 1 and 3 centers for intervention group 2)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
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
Vice Chancellor for Research and Technology., in front of the 17 Shahrivar Hospital., Shahid Siadati Street., Namjo Street
Before the intervention and after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: This group will first perform diaphragmatic breathing exercises for 4 weeks. After one week of wash out period, in the next 4 weeks of the study, they will do the pursed-lip breathing exercise.
Category
Rehabilitation
2
Description
Intervention group2: This group will first perform pursed-lip breathing exercises for 4 weeks. After one week of wash out period, in the next 4 weeks of the study, they will do the diaphragmatic breathing exercise.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
All Guilan Public Hospitals have Lung and Internal ward
Full name of responsible person
Azar Darvishpour
Street address
Vice Chancellor for Research and Technology., in front of the 17 Shahrivar Hospital., Shahid Siadati Street., Namjo Street
City
Rasht
Province
Guilan
Postal code
41466 -66949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Azar Darvishpour
Street address
Vice Chancellor for Research and Technology., in front of the 17 Shahrivar Hospital., Shahid Siadati Street., Namjo Street
City
Rasht
Province
Guilan
Postal code
41466 -66949
Phone
+98 13 3333 5821
Email
darvishpour_a@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Azar Darvishpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
City
Langeroud
Province
Guilan
Postal code
44771-66595
Phone
+98 13 4253 6263
Email
darvishpour_a@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Azar Darvishpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
City
Langeroud
Province
Guilan
Postal code
4477166595
Phone
+98 13 3333 5821
Email
darvishpour_a@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Azar Darvishpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
City
Langeroud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4253 6263
Email
darvishpour_a@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available