Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000459921
Ethics application status
Approved
Date submitted
28/04/2011
Date registered
4/05/2011
Date last updated
4/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of pulmonary rehabilitation program on self-efficacy and severity of symptoms among patients with chronic obstructive pulmonary disease
Scientific title
The effect of pulmonary rehabilitation program on self-efficacy and severity of symptoms among patients with chronic obstructive pulmonary disease
Secondary ID [1] 260084 0
Nil
Universal Trial Number (UTN)
U1111-1120-9982
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 265738 0
Condition category
Condition code
Respiratory 265875 265875 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention group recieve pulmonary rehabilitation program.
One of the Researchers instructed the pulmonary rehabilitation program to the experimental group. Educational session was held in single day and 3 part of 30 minutes. One part abut self care education, second about breathing techniques and last was exercise. Each time, patients feel tired the researcher renews practices after a period of rest. Pulmonary rehabilitation program included self care and self management education, nutrition recommendations, stress reduction methods (deep breathing, exercises, visual imagery, and progressive muscle relaxation), effective cough, breathing exercises (deep breathing, pursed lip breathing and diaphragmatic breathing), control of breathing in crucial situations, and muscle stretching exercises. In order to develop opportunities for enactive vicarious experience, researcher had performed Breathing exercises and muscle stretching exercises as a successful model and then asked patient to perform in front of her. Accuracy of learning checked and corrected by researcher in class.
Then patients were asked to perform exercise at home for 20 minutes 3 times a week for 7 week. Stretch muscle exercise program consisted 3 parts of warming, exercise, and cooling that had been accomplished morning and 1.30 hour after breakfast. Time of exercise gradually increased from base of 5 minutes to 20 minutes by adding 3 minutes per week. Also, patients were asked to perform breathing exercises three to four times a day and along with exercises. The usage of Respiratory exercise, muscle stretching exercises, effective cough, stress reduction methods and nutritional recommendations was checked by phone and record on usage checklists by patients and researchers separately. All of educational components with instruction of pulmonary rehabilitation program gathered in booklets which content were validated by 3 nursing experts and delivered to patient after educational sessions.
We developed the pulmonary rehabilitation program base on Bandura’s theory of self efficacy. So the program included components to develop the four sources of self-efficacy: 1- Mastery experiences: pulmonary rehabilitation program was accessible. Main goal for all patients was successful performance of pulmonary rehabilitation program. We increased the intensity of program gradually and fallowed patients by phone and answered to their questions. Hence attainment to mastery experience was predictable), 2- Verbal persuasion (telephone follow up intervention was conducted by researcher to reinforcement and assure the patient that they can do activities successful gradually), 3-Vicarious experiences (researcher modeled breathing and Stretch muscle exercises), and 4- Emotional arousal (we instructed patients about stress reduction methods, dyspnea management strategy, effective cough and exercise).
Telephone follow-up program provided according to self efficacy Bandura's theory and performed weekly for 7 week. Each telephone call lasted an average 15 minutes and consisted 4 parts: health behaviors assessment, reinforcement of education, answers to the patient questions and encourage patients to continue the performance. If there was non-adherence, the situation was analyzed and helps the patient to solve their problems.
Data were collected at baseline and after 7 week of intervention and analyzed.
Intervention code [1] 264487 0
Rehabilitation
Comparator / control treatment
The control group received only routine visits and telephone follow up weekly. Because results showed that pulmonary rehabilitation program is effective in reducing the severity of symptoms and improving self efficacy in the patients with COPD, one pulmonary rehabilitation program was held for control group and delivered educational booklet to patients. Educational booklet consisted all of educational components with instruction of pulmonary rehabilitation program.
Control group
Active

Outcomes
Primary outcome [1] 266645 0
Self efficacy as assessed with COPD Self Efficacy Scale (CSES)
Timepoint [1] 266645 0
before and after intervention
Primary outcome [2] 266646 0
severity of fatigue as assessed with Fatigue Severity Scale (FSS)
Timepoint [2] 266646 0
before and after intervention
Primary outcome [3] 266647 0
severity of dyspnea as assessed with Dyspnea Severity Scale
Timepoint [3] 266647 0
before and after intervention
Primary outcome [4] 266648 0
severity of cough as assessed with cough Severity Scale
Timepoint [4] 266648 0
before and after intervention
Secondary outcome [1] 276139 0
demographic and disease related information as assessed with demographic and disease related questionnaire
Timepoint [1] 276139 0
before intervention

Eligibility
Key inclusion criteria
Inclusion criteria included age lower than 65 years, verification of diagnosis of moderate to severe COPD that means Adherence to the ratio of FEV1 to FVC of less than 70 percent and FEV1 value greater than or equal to 80% of the predicted normal values criterion in GOLD stage I ; FEV1 value between 50% and 79% of the predicted normal values with ratio of FEV1 to FVC of less than 70 criterion in GOLD stage II , absence of formal exercise training or pulmonary rehabilitation for at least one year, absence of active symptomatic diseases (cardiac disease, musculoskeletal disease, mental disease) that would interfere with exercise, literate and able to speak Persian, possibility of contact by phone/mobile phone.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included of recent exacerbation or change of medication, recent mobility limitation that interfere with exercise, not participate in educational session, and lack of employing nutritional recommendation or exercise and respiratory practice for at least a week.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 3425 0
Iran, Islamic Republic Of
State/province [1] 3425 0
tehran

Funding & Sponsors
Funding source category [1] 264984 0
University
Name [1] 264984 0
Tehran University of Medical Science
Country [1] 264984 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical Science
Address
Tehran- Keshavarz boulevard-Ghods street
postcode:1417653761
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 264072 0
Hospital
Name [1] 264072 0
Masih daneshvari
Address [1] 264072 0
Tehran- Darabad-Oshan boulevard
postcode: 1956944413
Country [1] 264072 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266925 0
Ethics in Research Committee Tehran University of Medical Sciences
Ethics committee address [1] 266925 0
Ethics committee country [1] 266925 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 266925 0
Approval date [1] 266925 0
08/05/2010
Ethics approval number [1] 266925 0
89/130/189

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32541 0
Address 32541 0
Country 32541 0
Phone 32541 0
Fax 32541 0
Email 32541 0
Contact person for public queries
Name 15788 0
sahar khoshkesht
Address 15788 0
Tehran- Tohid Squre- Nosrat Steet- college of Nursing and Midwifery
postcode:1419733171
Country 15788 0
Iran, Islamic Republic Of
Phone 15788 0
0982166943187
Fax 15788 0
Email 15788 0
[email protected]
Contact person for scientific queries
Name 6716 0
sahar khoshkesht
Address 6716 0
Tehran- Tohid Squre- Nosrat Steet- college of Nursing and Midwifery
postcode:1419733171
Country 6716 0
Iran, Islamic Republic Of
Phone 6716 0
0982166943187
Fax 6716 0
Email 6716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.