Protocol summary

Study aim
Investigating the effect of aerobic exercises along with chest physiotherapy in improving the quality of life of cystic fibrosis patients referred to Masih Daneshvari Hospital.
Design
A controlled, parallel-group, double-blind, randomized clinical trial on 40 patients. A table of random numbers was used for randomization.
Settings and conduct
This study is conducted as a clinical trial on COPD patients referred to Masih Deneshvari Hospital in Tehran. Patients who meet the study entry criteria are placed in one of the two study groups after providing explanations and signing a written consent form.
Participants/Inclusion and exclusion criteria
Inclusion criteria will include age over 18, patients in stable phase, and doctor's definite diagnosis of CF. Also, patients who have contraindications for rehabilitation and respiratory physiotherapy, such as respiratory distress and hemoptysis, or who do not wish to continue participating in the research plan, will be excluded from the study.
Intervention groups
In the intervention group, patients will receive common respiratory physiotherapy treatment, including sputum and secretion drainage techniques, breathing exercises. In addition, aerobic exercises using bicycles and treadmills, including 10 minutes of bicycle use as warm up and 15 minutes of walking on the treadmill, the intensity of which is calculated based on the six-minute walking test distance for each person. In the control group, the patients will only receive the common treatment of respiratory physiotherapy, including phlegm and secretion drainage techniques, breathing exercises.
Main outcome variables
Maximum exercise capacity, FEV1, FVC, RV, TLC, VO2max, fatigue during activity, resting heart rate, oxygen saturation at rest

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240413061474N1
Registration date: 2024-05-15, 1403/02/26
Registration timing: prospective

Last update: 2024-05-15, 1403/02/26
Update count: 0
Registration date
2024-05-15, 1403/02/26
Registrant information
Name
Abouzar Mojibian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9946
Email address
dr.a.mojibian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aerobic exercises along with chest physiotherapy in quality of life of cystic fibrosis patients referred to Masih Daneshvari Hospital.
Public title
The effect of aerobic exercises along with chest physiotherapy in adult cystic fibrosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 Doctor's definitive diagnosis of CF Patients in the stable phase
Exclusion criteria:
Respiratory distress Hemoptysis
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple, randomization unit: individual, randomization tool: random number table. To create a random sequence, with the help of a random number table and by a statistical consultant, the patients were randomly given one of the even and odd codes. Patients who were assigned even numbers were in the first group and patients with odd codes were in the second group.
Blinding (investigator's opinion)
Single blinded
Blinding description
To avoid possible risks, the main researcher is fully aware of the allocation of groups. The person assessing the outcome and analyzing the data is kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of institute of tuberculosis and lung disease of shahid beheshti univerity of medic
Street address
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2023-08-23, 1402/06/01
Ethics committee reference number
IR.SBMU.NRITLD.REC.1402.104

Health conditions studied

1

Description of health condition studied
Cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis

Primary outcomes

1

Description
maximum exercise capacity
Timepoint
Before and after rehabilitation or physiotherapy
Method of measurement
Six-minute walk test

2

Description
Forced expiratory volume in the first second
Timepoint
Before and after rehabilitation or physiotherapy
Method of measurement
Spirometry

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and after rehabilitation or physiotherapy
Method of measurement
12-Item Short Form Health Survey questionarie (SF-12)

Intervention groups

1

Description
Intervention group: Patients will receive common respiratory physiotherapy treatment including phlegm and secretion drainage techniques, breathing exercises (including diaphragmatic breathing, chest expansion exercises and posture correction exercises). In addition, aerobic exercises using bicycles and treadmills, including 10 minutes of bicycle use as warm up and 15 minutes of walking on the treadmill, the intensity of which is calculated based on the six-minute walking test distance for each person. In treadmill training (walking on a treadmill), the first 2 minutes are allocated to warm-up and the last 2 minutes to cool down. After the workout, stretching exercises will be done to prevent muscle pain.
Category
Rehabilitation

2

Description
Control group: Patients will receive the only common treatment of respiratory physiotherapy, including phlegm and secretion drainage techniques, breathing exercises (including diaphragmatic breathing, chest expansion exercises, and posture correction exercises).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Abouzar Mojibian
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
dr.a.mojibian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Abedi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
mohsenabedi110@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abouzar Mojibian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
195694413
Phone
+98 21 2610 5050
Email
dr.a.mojibian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhaneh Zahiri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Others
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
19995644413
Phone
+98 21 2610 5050
Email
zahirireyhane@gmail.com

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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