Protocol summary

Study aim
To determine the effect of acupressure on spirometry indicators and functional exercise capacity in people with chronic obstructive pulmonary disease.
Design
This research study is a randomized triple-blinded clinical trial with parallel groups. The three groups will be similar in age and gender. For placement of the samples in the three intervention groups, placebo and the routine care group (control), a simple random method will be used. The sample size was estimated by the results of the studies and the sample size formula was estimated to be 40 in each group.
Settings and conduct
The patients of the intervention and Placebo group will be selected from the Pulmonary clinic of Imam Sajjad Hospital, Ramsar. The control group will be selected from the Pulmonary clinic of Shahid Rajaei Tankabon Hospital. The data will be collected by the interview method. In this study, the participants are blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: full consciousness, ability to walk independently, Absence of allergies, Non-smoking, ability to sleep in the prone position. Exclusion criteria: exacerbated chronic obstructive pulmonary disease (COPD), Acute respiratory disease
Intervention groups
In the intervention group, four points were selected including Dingchuan point EX.17, UB.13 Feishu point, UB.23 Shenshu point and St.36 Zusanli point,Then acupressure will be done for 3 minutes, 3 times a week and for 4 weeks. In the placebo group, acupressure will be performed at a distance of 1.5 centimeters from the main points. In the control group, routine care will be taken and there will be no intervention.
Main outcome variables
Spirometric indicators, Functional exercise capacity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160802029159N2
Registration date: 2022-09-26, 1401/07/04
Registration timing: prospective

Last update: 2022-09-26, 1401/07/04
Update count: 0
Registration date
2022-09-26, 1401/07/04
Registrant information
Name
Moloud Sharifi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 5525 8118
Email address
m.sharifi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on Spirometry Indicators and Functional Exercise Capacity in people with Chronic Obstructive Pulmonary Disease (COPD)
Public title
The Effect of Acupressure on Spirometery Indicators and Functional Exercise Capacity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness Ability to walk independently Diagnosis of COPD by an internal medicine Having an FEV1 to FVC ratio of less than 0.7 after bronchodilators No smoking (cigarettes and hookahs) Lack of allergies, Absence of an obstacle to the practice of acupressure Lack of visual impairment The ability to get on the prone position Not having previous experience of acupressure or acupuncture
Exclusion criteria:
Exacerbated Chronic Obstructive Pulmonary Disease Acute Respiratory Disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 120 participants with Chronic Obstructive Pulmonary Disease will be randomly assigned into one of three groups: one intervention group (acupressure), one control group; and one placebo group. The eligible people will be in the study groups by a randomization process. The random allocation of this study will be achieved using an online random number generator (randomization.com) following a balanced 1:1 pattern. The information on the allocation list will remain strictly confidential and sequentially numbered; opaque, sealed envelopes will be used to contain the randomization assignments. The Acupressure Specialist will open the envelopes according to the numerical sequence, immediately before the first session of treatment
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will remain blinded regarding the category of their allocation throughout the study data collection period. Additionally, the evaluators responsible for the data collection and the outcomes assessor will also be blinded to the patient allocation. The Acupressure Specialist will be the only person not blind to the type of treatment to be performed
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gangafrooz Street, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.001

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
Z82.5
ICD-10 code description
Family history of asthma and other chronic lower respiratory diseases

Primary outcomes

1

Description
Spirometric indices
Timepoint
The spirometric indices are evaluated in three sessions of the first, sixth and twelfth sessions (immediately before the first session, the sixth session and immediately after the 12th session).
Method of measurement
Spirometry machine model HI-801

2

Description
Functional exercise capacity
Timepoint
Functional exercise capacity will be evaluated in three sessions of the first, sixth and twelfth sessions (immediately before the first session, sixth session and immediately after the twelfth meeting).
Method of measurement
Six-Minute Walking Practice Test (6MWT): This is a simple test to assess the ability of a person's performance and can reflect the ability of an individual to operate on a daily basis.

Secondary outcomes

1

Description
Dyspnea
Timepoint
Dyspnea will be evaluated in three sessions of the first, sixth and twelfth sessions (immediately before the first meeting, sixth session and immediately after the twelfth meeting).
Method of measurement
Dyspnea Visual Analogue Scale

Intervention groups

1

Description
Intervention group: In the intervention group, 4 points including the point (EX.17)Dingchuan (at 5 cun intervals with the C7 neck neck) (due to the fact that each cun is approximately the same as the width of the thumb), the point (UB.13) Feishu (1 / 5th cun is located next to the T-3 thoracic vertebra), point (UB.23) Shenshu is located 1 / 5th cun along the lumbar vertebra L2) and the point (St.36) Zusanli (lower than the lower knee joint of the tibia tetanus) and then acupressure (12 sessions) for 3 minutes (a total of 12 minutes), 3 times per week and for 4 weeks.
Category
Rehabilitation

2

Description
Control group: In the placebo group, 1.5 centimeters distance from the main acupressure program will be implemented.
Category
Rehabilitation

3

Description
Control group: In the control group, routine care will be taken and there will be no intervention.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Moloud Sharifi
Street address
Motahhari Ave; Revolution Square; Ramsar; Mazandaran
City
رامسر
Province
Mazandaran
Postal code
4691714141
Phone
+98 11 5522 5151
Fax
+98 11 5522 6413
Email
sharifi.molod@gmail.com

2

Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Moloud Sharifi
Street address
Imam Street, In front of the Bank Melli Iran
City
Tonekabon
Province
Mazandaran
Postal code
4281989888
Phone
+98 11 5423 7001
Email
rajaeehospital995@gmail.com
Web page address
http://en-ipd-h-rajaei.mazums.ac.ir/Home

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Sciences; Gangafrooz Ave; Babol; Mazandaran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0557
Fax
+98 11 2199 2080
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Moloud Sharifi
Position
Non-faculty educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Motahhari Ave; Enghelab Square; Ramsar; Mazandaran; Iran
City
Ramsar
Province
Mazandaran
Postal code
4691857995
Phone
+98 11 5525 8118
Fax
+98 11 5522 6413
Email
m.sharifi@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Moloud Sharifi
Position
Non-faculty educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Motahhari Ave; Enghelab Square; Ramsar; Mazandaran; Iran
City
Ramsar
Province
Mazandaran
Postal code
4691857995
Phone
+98 11 5525 8118
Fax
+98 11 5522 6413
Email
m.sharifi@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Moloud Sharifi
Position
Non-faculty educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Motahhari Ave; Enghelab Square; Ramsar; Mazandaran; Iran
City
Ramsar
Province
Mazandaran
Postal code
4691857995
Phone
+98 11 5525 8118
Fax
+98 11 5522 6413
Email
m.sharifi@mubabol.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The data will be shared with the Ethics Committee of the Babil University of Medical Sciences after the analysis in the text of the article and the report of the end of the work.
When the data will become available and for how long
7 months
To whom data/document is available
Only the research team and the Ethics Committee of the Babil University of Medical Sciences have access to raw data.
Under which criteria data/document could be used
Increased clinical application of the study results
From where data/document is obtainable
Refer to the administrator and address of Fatemeh Zahra Faculty of Nursing, Ramsar
What processes are involved for a request to access data/document
The request must be submitted to the administrator's email address and the submitter, after consulting and consulting with the research team, will refer the request to the university's ethics committee and, upon receipt of the approval of the ethics committee, will provide the applicant with the data.
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