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The Effect of Local heat Therapy on the Respiratory Indicators and Fatigue in Patients with Chronic Obstructive Pulmonary Disease

Protocol summary

Study aim
determination The Effect of Local heat Therapy on the Respiratory Indicators and Fatigue in Patients with Chronic Obstructive Pulmonary Disease
Design
A randomized trial with intervention and control groups, unblinded, random allocation by permutation block method, 48 patients with Chronic obstructive pulmonary disease
Settings and conduct
Gonabad Allame Bohlool Hospital - Patients will be randomly divided into two intervention and control groups. For control group hot pack at 37 ° C and for the intervention group, a hot pack at 50 ° C will be placed. Fatigue severity and respiratory parameters will be assessed before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Stage of 1-4 in Chronic obstructive pulmonary disease according to GOLD criteria, BMI between 18.5-25 kg/m2, Alertness, ability to speak and communicate, Stable physiological status for answer questions The presence of lesions (swelling, sores, scratches, and redness) in the chest area Exclusion criteria: Structural disorder and deformity in the chest area,The history of mental disorder and hyperthyroidism based on patient reports, The presence of cardiac arrhythmia, Spirometric contraindication conditions (uncontrolled hypertension, contagious respiratory infection, active hemoptysis, recent eye or ear surgery, rupture of tympan, the recent CVA or pulmonary embolism, the history of myocardial infarction or unstable angina in recent 6 weeks)
Intervention groups
Heat therapy group at 50 ° C and control group at 37 ° C (room temperature)
Main outcome variables
Respiratory indices and fatigue severity before and after the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161004030141N1
Registration date: 2020-02-04, 1398/11/15
Registration timing: registered_while_recruiting

Last update: 2020-02-04, 1398/11/15
Update count: 0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 57254394
Email address
shahpasand.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Local heat Therapy on the Respiratory Indicators and Fatigue in Patients with Chronic Obstructive Pulmonary Disease
Public title
The Effect of Local heat Therapy on the Respiratory Indicators and Fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stage of 1-4 in Chronic obstructive pulmonary disease according to GOLD criteria BMI between 18.5-25 kg/m2 Alertness, ability to speak and communicate Stable physiological status for answer questions
Exclusion criteria:
The presence of lesions (swelling, sores, scratches, and redness) in the chest area Structural disorder and deformity in the chest area The history of mental disorder and hyperthyroidism based on patient reports The presence of cardiac arrhythmia Spirometric contraindication conditions (uncontrolled hypertension, contagious respiratory infection, active hemoptysis, recent eye or ear surgery, rupture of tympan, the recent CVA or pulmonary embolism, the history of myocardial infarction or unstable angina in recent 6 weeks)
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two experimental and control groups based on permutation blocks. Six possible modes will be listed randomly and after determining the number of blocks, individuals will be allocated to the experimental and control groups, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in Gonabad University of Medical Science
Street address
Gonabad University of Medical Sciences, Next to the Asian road, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.GMU.REC.1398.079

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Vital Capacity
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Spirometry

2

Description
Force Vital Capacity
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Spirometry

3

Description
Forced Expiratory Volume in First Second
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Spirometry

4

Description
Peak Expiratory Flow Rate
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Spirometry

5

Description
Forced expiratory flow at 25-75% of vital capacity
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Spirometry

6

Description
FEV1/FVC
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Spirometry

7

Description
Respiratory rate
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Number per minute

8

Description
Oxygen saturation percentage (SPO2)
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Pulse Oximeter Device

9

Description
Fatigue severity
Timepoint
At baseline (before intervention), 6 days after first intervention
Method of measurement
Crop questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in this group will be used a hot pack for topical heat therapy, a special 25×35 standard linen bag containing hydrophilic silicate and charged by a hydrocollator up to 50 ° C. Then the hot pack will be placed in a special towel and used in anterior part of chest for 23 minutes twice a day every, heat therapy will continue for five days. Heat therapy will continue for five days.
Category
Treatment - Other

2

Description
Control group: in this group will be used a hot pack for topical heat therapy, a special 25×35 standard linen bag containing hydrophilic silicate and charged by a hydrocollator up to 37° C. Then the hot pack will be placed in a special towel and used in anterior part of chest for 23 minutes twice a day every, heat therapy will continue for five days. Heat therapy will continue for five days.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonabad Allame Bohlool hospital
Full name of responsible person
Masume Shahpasand
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691639378
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
masume.shahpassand@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Research Deputy of Gonabad University of Medical Sciences
Street address
Next to the Asian Road, Gonabad University of Medical Sciences, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
Research@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Masume ُُShahpasand
Position
MSc. student in Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Next to the Asian Road, Gonabad University of Medical Sciences, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
shahpasand.m@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Mohammadpour
Position
PhD In Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Email
amohmmadpur@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Masume Shahpasand
Position
Master of Internal Surgery Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Next to the Asian Road, Gonabad University of Medical Sciences, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5725 3028
Email
shahpasand.m@gmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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