Protocol summary

Summary
This study aimed to evaluate the effect of reflexology on physiological parameter , pulmonary functionss and quality of life in men above 50 years. Patients with moderate to severe chronic obstructive pulmonary disease. Degree Qualified randomly divided into two groups.The first group of massage1 time for 6 weeks for 40 minutes with olive oil on both feet. The general foot massage and 10 minutes from the 10 minutes of the lungs and chest compressions should be performed. The control group did not receive anything.Quality of life questionnaire and lung function form for both groups After the last session was completed.To Physiologic parameters as the primary out come in this study is considered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212176918N14
Registration date: 2013-01-12, 1391/10/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-01-12, 1391/10/23
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Foot reflexology impact on physiological parameters, pulmonary function and quality of life in patients with chronic obstructive pulmonary disease
Public title
Foot Massage
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Male patients 50 years and older,Patients with moderate to severe chronic obstructive pulmonary disease,A relative independence in activities of daily living, A willingness and interest in participating in the study,Were married and living in a suburb of Tabriz Exclusion criteria: Having a chronic illness duck the other, Having problems on foot including blood problems, Participate in other similar studies in the past 6 months, Use of other complementary and alternative medicine methods in the study
Age
To 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Postal code
5138947979
Approval date
2012-12-26, 1391/10/06
Ethics committee reference number
8447/10

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmunary Disease
ICD-10 code
j44.1
ICD-10 code description
With Acute Exacerbation

Primary outcomes

1

Description
Physologycal index
Timepoint
Once a week, before and after
Method of measurement
Using a blood pressure sphygmomanometer in millimeters of mercury,Heart rate and oxygen saturation by pulse oximetry

Secondary outcomes

1

Description
Lung Function
Timepoint
Baseline and 6 weeks after the intervention
Method of measurement
Lung function with Spiro meter

2

Description
Quality of life
Timepoint
Baseline and 6 weeks after the intervention
Method of measurement
Quality of life using the St George's Questionnaire Form Quality of Life

Intervention groups

1

Description
The foot reflexology group, Reflexology in certain parts of the lungs in detail below metatarsophalangeal joint between the fingers and feet are the first times a week for 6 weeks hospital room at the hospital respirators Imam Reza (AS)In morning business for 40 minutes using olive oil in a supine position with both feet20 minutes for each leg), 10 minutes from the general foot massage and 10 minutes of the lungs and chest compressions are performed.
Category
Rehabilitation

2

Description
In the control group, there was no action.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Center of Imam Reza (AS)
Full name of responsible person
hossein kalantary segayesh
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr, Ali Shakory
Street address
Shariety South St ; Faculty of Nursing & Midwifery of Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of medical Sciences
Full name of responsible person
Alehe Seyyedrasooly
Position
Msn Student
Other areas of specialty/work
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Postal code
5138947979
Phone
+98 41147773779
Fax
Email
seyyedrasooly@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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