1. Home
  2. Approved trials
  3. » فارسی

The effect of a combined training course and Nacetylcysteine supplementation on the levels of inflammatory indicators, serum oxidative stress and pulmonary function in patients with chronic obstructive pulmonary disease

Protocol summary

Study aim
Our aim is to investigate the effects of combined exercise and TaiChi Chuan along with N-acetylcysteine supplementation on the levels of inflammatory factors and oxidative stress indicators, in patients with chronic obstructive pulmonary disease.
Design
The clinical trial has control and intervention groups, double-blind, randomized, and random concealment by a third person using a table of random numbers.
Settings and conduct
This double-blind study will be conducted in a medical center under the supervision of expert sports coaches and doctors.
Participants/Inclusion and exclusion criteria
Patients with chronic obstructive pulmonary disease. Patients who have not received any antibiotics, glucocorticoids and theophylline drugs in the 2 weeks before entering the study. Patients who have signed the informed consent form for voluntary participation in the study. Exclusion criteria include: patients who, in addition to COPD, have interstitial fibrosis, tuberculosis, bronchial pneumonia, lung cancer, patients with non-respiratory diseases such as: diabetes, severe heart and brain diseases, neurological diseases, Liver and kidney function and patients suffering from mental diseases and cognitive impairment
Intervention groups
Patients will be divided into four groups 1 supplement-exercise group, 2 placebo-exercise group, 3 supplement group, 4 placebo group.The intervention will include doing combined exercises, on even days, combined exercises that include resistance and aerobic exercises will be used. Also, on individual days, patients will perform tai chi and TBRS exercises.Subjects in the supplement group will take 1800 mg Nacetylcysteine supplement3times a day and one 600 mg tablet per meal). Also, the placebo group will be prescribed the same amount of placebo
Main outcome variables
inflammatory indicators,oxidative stress,pulmonary function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240227061121N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: registered_while_recruiting

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Amirreza Ebrahimi Samarin
Name of organization / entity
The University of Mazandaran
Country
Iran (Islamic Republic of)
Phone
+98 21 5566 9738
Email address
a.ebrahimi01@umail.umz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-22, 1403/04/02
Expected recruitment end date
2024-07-18, 1403/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a combined training course and Nacetylcysteine supplementation on the levels of inflammatory indicators, serum oxidative stress and pulmonary function in patients with chronic obstructive pulmonary disease
Public title
The effect of a combined training course and Nacetylcysteine supplementation on the levels of inflammatory indicators, serum oxidative stress and pulmonary function in patients with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic obstructive pulmonary disease who have been confirmed by a specialist doctor. Patients who have not received any antibiotics, glucocorticoids and theophylline drugs in the 2 weeks before entering the study Patients who have signed the informed consent form for voluntary participation in the study.
Exclusion criteria:
Pulmonary interstitial fibrosis Tuberculosis Bronchial pneumonia Lung cancer diabetes Functional liver diseases Cardiovascular diseases Neurological diseases Severe brain disease mental illnesses Cognitive impairment disease Functional kidney diseases
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 patients with chronic obstructive pulmonary disease are selected in a semi-experimental design and randomly divided into 4 groups. First, each person is assigned a number, then using the table of random numbers, each randomly selected number is assigned to one of the groups, and this work continues until the number of people in each group is completed. Therefore, the researcher has no authority to change the appointment status of people or predict it. Concealment of randomization is performed by a third person who does not participate in the interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to comply with the double-blind method, the supplements were coded and another reference was used as an informed person, and at the end of the research, the codes were opened and the group of each person was determined.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of University of Mazandaran
Street address
13th floor, Block A, central headquarters of the ministry of health, treatment and medical education, between South flamak and zrafshan, quads town
City
Tehran
Province
Mazandaran
Postal code
14177733161
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.UMZ.REC.1403.020

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease(COPD)
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
fibrinogen
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples, spirometry, questionnaire

2

Description
interleukin-1
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

3

Description
interleukin-6
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

4

Description
interleukin-8
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

5

Description
TNF-a
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

6

Description
C-reactive protein
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

7

Description
nitric oxide
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

8

Description
xanthine
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

9

Description
superoxide dismutase
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

10

Description
glutathione peroxidase
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

11

Description
malondialdehyde
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
Collection of blood samples

12

Description
forced expiratory volume in one second (FEV1)
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
spirometry

13

Description
forced vital capacity ( FVC)
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
spirometry

14

Description
Health-related quality of life
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
questionnaire

15

Description
sleep quality
Timepoint
24 hours before the start of the study and 48 hours after the last day of the study (12 weeks later)
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Supplement training group: Subjects in this group will take 1800 mg of N-acetylcysteine supplement (3 times a day and one 600 mg tablet per meal). The combined training program will last for 12 weeks with a frequency of three sessions per week, approximately 60 minutes per session and a total of 36 sessions. Sessions will begin with general dynamic stretching. Aerobic exercise on the treadmill will start for 30 minutes with an intensity of 80% of the average speed obtained in the six-minute walking test (MWT6) and the progress will be based on subjective feeling (from shortness of breath, 4 to 6 on the Borg scale). Therefore, exercise intensity is maintained when the individual reports breathlessness with values between 4 and 6 on the Borg scale. However, when the intensity was less than 4, there would be a 5% increase in exercise intensity. For resistance training, the maximum 1 repetition maximum test (RM 1) will be performed from the following muscle groups (elbow flexors, and knee extensors and flexors) and the intensity of the exercises will be 60 to 80% of 1RM. Resistance exercises in each movement will include 3 sets of 10 repetitions with two-minute rest intervals between sets. The increase in the load of each session will be done with a 5% increase in the intensity of the RM 1 test to reach 80%. The program of Tai Chi exercises will be taught as TBRS on odd days. A 30-minute tai chi practice will be performed three times a week for three months under the supervision and training of certified tai chi instructors. Training techniques and safety precautions for each movement will be explained and demonstrated throughout the training session. Participants will always be instructed to focus on breathing control and body movements during the exercise. TBRS is a low-impact, seated exercise method that has been shown to significantly increase exercise capacity, reduce dyspnea, and reduce the number of acute exacerbations in COPD patients. It is a commonly used method of exercise in fitness and rehabilitation that offers better safety and a higher dose of exercise for patients who cannot perform traditional treadmill exercise. Participants in the TBRS group will be trained by an experienced physical therapist on equipment operation, exercise protocol, termination criteria, and emergency notification prior to exercise. The exercise will start with a step song of 40 to 60 steps per minute. However, a three-month program will be performed with a 30-minute training session (including warm-up and cool-down) three times per week. Participants in the tai chi group performed a 15-minute TBRS exercise followed by a 15-minute tai chi exercise.
Category
Rehabilitation

2

Description
Intervention group: The subjects of this group will take 1800 mg Nacetylcysteine supplement (3 times a day and one 600 mg tablet per meal).
Category
Rehabilitation

3

Description
Intervention group: The combined training program will last for 12 weeks with a frequency of three sessions per week, approximately 60 minutes per session and a total of 36 sessions. Sessions will begin with general dynamic stretching. Aerobic exercise on the treadmill will start for 30 minutes with an intensity of 80% of the average speed obtained in the six-minute walking test (MWT6) and the progress will be based on subjective feeling (from shortness of breath, 4 to 6 on the Borg scale). Therefore, exercise intensity is maintained when the individual reports breathlessness with values between 4 and 6 on the Borg scale. However, when the intensity was less than 4, there would be a 5% increase in exercise intensity. For resistance training, the maximum 1 repetition maximum test (RM 1) will be performed from the following muscle groups (elbow flexors, and knee extensors and flexors) and the intensity of the exercises will be 60 to 80% of 1RM. Resistance exercises in each movement will include 3 sets of 10 repetitions with two-minute rest intervals between sets. The increase in the load of each session will be done with a 5% increase in the intensity of the RM 1 test to reach 80%. The program of Tai Chi exercises will be taught as TBRS on odd days. A 30-minute tai chi practice will be performed three times a week for three months under the supervision and training of certified tai chi instructors. Training techniques and safety precautions for each movement will be explained and demonstrated throughout the training session. Participants will always be instructed to focus on breathing control and body movements during the exercise. TBRS is a low-impact, seated exercise method that has been shown to significantly increase exercise capacity, reduce dyspnea, and reduce the number of acute exacerbations in COPD patients. It is a commonly used method of exercise in fitness and rehabilitation that offers better safety and a higher dose of exercise for patients who cannot perform traditional treadmill exercise. Participants in the TBRS group will be trained by an experienced physical therapist on equipment operation, exercise protocol, termination criteria, and emergency notification prior to exercise. The exercise will start with a step song of 40 to 60 steps per minute. However, a three-month program will be performed with a 30-minute training session (including warm-up and cool-down) three times per week. Participants in the Taichi group performed a 15-minute TBRS workout followed by a 15-minute Tai Chi workout. They will take 1800 mg placebo (3 times a day and one 600 mg tablet per meal).
Category
Rehabilitation

4

Description
Control group: They will take 1800 mg placebo (3 times a day and one 600 mg tablet per meal).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari hospital
Full name of responsible person
Parisa Farnia
Street address
Darabad, Shahid Bahonar street
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Fax
+98 21 2610 9680
Email
pr.nritld@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Mazandaran
Full name of responsible person
Jamal Ghasemi
Street address
Central organisation, Pasdaran street, Babolsar
City
Babolsar
Province
Mazandaran
Postal code
4741613534
Phone
+98 11 3530 2000
Email
info@umz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Amirreza Ebrahimi Samarin
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiologist
Street address
No 33. Homafar ally, Naimi street
City
Tehran
Province
Tehran
Postal code
1359836889
Phone
+98 21 5566 9738
Email
amirrezaebrahimisamarin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Amirreza Ebrahimi Samarin
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiologist
Street address
No. 33, Homafar ally, Naimi street
City
Tehran
Province
Tehran
Postal code
1359836889
Phone
+98 21 5566 9738
Email
amirrezaebrahimisamarin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Amirreza Ebrahimi Samarin
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiologist
Street address
No.33, Homafar ally, Naimi Avu
City
Tehran
Province
Tehran
Postal code
1359836889
Phone
+98 21 5566 9738
Email
amirrezaebrahimisamarin@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
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
All potential data can be shared after de_identifying individual
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions as well as doctors
Under which criteria data/document could be used
Due to the importance of developing rehabilitation solutions, there is no virtual limit for using data and the use is unimpeded for researchers
From where data/document is obtainable
Researcher's Email
What processes are involved for a request to access data/document
A message is sent to the researcher and after checking th applicant's documents, the data will be sent to the applicant
Comments
Loading...