Protocol summary

Summary
This study aim at comparing the effect of physiotherapy of limbs and chest with that of routine physiotherapy procedures on the changes in physiological indices in patient hospitalize in ICUs. Inclusion criteria for the study include: over 18 years of age, informed consent of the patient’s parents/guardian for participation in the research, at least 2 days of hospitalization in intensive care unit, having stable hemodynamics, and having GCS lower than seven and being under ventilator (intubate). Exclusion criteria are refusal of the patient’s parents/guardian to continue the study, the incidence of severe reduction in left ventricular contractility (less than 30 percent) and the incidence of severe renal dysfunction (urine out put less than 30cc/hr). In an interventional study, the subjects will be selected by convenience sampling and randomly divided into three groups (two intervention groups and one control group). The study population are the patients admitted to ICUs and the sample size is 90. After selecting the patients, chest physiotherapy will be carried out by the physiotherapist in the first intervention group and physiological indices (blood pressure, respiratory rate, and arterial oxygen saturation) will be checked before, during, 1 hour later, and 2 hours later. In the second intervention group, limb physiotherapy will be carried out by the physiotherapist and physiological indices are check in the first group. In contrast, routine physiotherapy procedures of ICUs will be used for the patients in the control group and physiological indices are evaluate as in the two intervention groups. Finally, the results is analyze by the statistician.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110921896N6
Registration date: 2015-12-24, 1394/10/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Mokhtar Mahmoudi
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 4435 5764
Email address
mokhtar.mahmoudi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
This budget will be provided by Arak University of Medical Sciences.
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparingthe Effect of Physiotherapy of Limbs and Chest on Physiological Indices of Patients Admitted to Intensive Care Units (ICUs)
Public title
Comparingthe Effect of Physiotherapy of Limbs and Chest on Physiological Indices of Patients Admitted to Intensive Care Units (ICUs)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: over 18 years of age, informed consent of the patient’s parents/guardian for participation in the research;at least 2 days of hospitalization in intensive care unit, having stable hemodynamics; having GCS lower than seven and being under ventilator (intubated) Exclusion criteria: refusal of the patient’s parents/guardian to continue the study; the incidence of severe reduction in left ventricular contractility ( less than 30 percent); the incidence of severe renal dysfunction (urine output less than 30cc/hr)
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Of Arak University Of Medical Science
Street address
Sardasht Street, Arak University Of Medical Science,Arak
City
Arak
Postal code
Approval date
2015-09-14, 1394/06/23
Ethics committee reference number
IR.ARAKMU.REC.1394.179

Health conditions studied

1

Description of health condition studied
limb and chest physiotherapy
ICD-10 code
Chapter XI
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
chest physiotherapy
Timepoint
1 hours ago,during,after 1 hours,after 2 hours
Method of measurement
evaluation of physiologic index

2

Description
limb physiotherapy
Timepoint
1 hours ago,during,after 1 hours,after 2 hours
Method of measurement
evaluation of physiologic index

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: in the first intervention group and physiological indices (blood pressure, respiratory rate, and arterial oxygen saturation) will be checked before, during, 1 hour later, and 2 hours later.
Category
Rehabilitation

2

Description
second intervention: In the second intervention group, limb physiotherapy will be carried out by the physiotherapist and physiological indices will be checked as in the first group.
Category
Treatment - Drugs

3

Description
control group:routine physiotherapy procedures of ICUs will be used for the patients in the control group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Training And Remedial Center
Full name of responsible person
Ms Hajian Leila
Street address
Amiralmomenin Hospita Center,Sardasht Street,Arak,Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr Rafii Mohammad
Street address
College Of Nursing And Midwifery,Sardasht Street, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak 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
College Of Nursing & Midwifery
Full name of responsible person
Mahmoudi Mokhtar
Position
Msc in Nursing
Other areas of specialty/work
Street address
Arak, Sardasht, College Of Nursing & Midwifery
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
mahmodimokhtar85@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak Medical University
Full name of responsible person
Mahmoudi Mokhtar
Position
Msc in Nursing
Other areas of specialty/work
Street address
Sardasht,College Of Nursing & Midwifery Of Arak
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
mahmodimokhtar85@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Colege of Nursing And Midwifery Of Arak
Full name of responsible person
Mahmoudi Mokhtar
Position
Msc in Nursing
Other areas of specialty/work
Street address
Sardasht Street, College Of Nursing & Midwifery
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
mahmodimokhtar85@gmail.com
Web page address

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
Loading...