Protocol summary

Study aim
Comparison of the effect of intermittent high-intensity exercise, moderate-intensity intermittent exercise, and continuous exercise on blood inflammatory indices and respiratory indices in patients with chronic obstructive pulmonary disease.
Design
The current clinical trial study has three intervention groups and one control group, with parallel and double-blind groups, randomized and with a sample size of 45 patients.
Settings and conduct
This study is conducted as a clinical trial in COPD patients referred to Masih Deneshvari Hospital in Tehran. Based on the results obtained from the laboratory tests, the clinical conditions of the patients before and after performing each group of exercises are compared with each other. Randomization will be done with the help of codes assigned to patients and based on their file numbers. Blinding is for patients and laboratory personnel, and the rehabilitation person who is a physiotherapist cannot be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria included ages between 20-70 years, and patients with COPD grades 2 and 3. Exclusion criteria included moderate to severe learning difficulties, movement problems, confusion, disorientation or terminal illness, and congestive heart failure.
Intervention groups
In the control group, patients perform moderate-intensity continuous exercises. In the first intervention group, high-intensity interval training, activity duration of 4 hours and duration recovery for 3 minutes, in the second intervention group, high-intensity interval training, activity duration of 2 minutes and duration recovery of 1 minute, and in the third intervention group, high-intensity interval training, activity duration for 30 seconds and duration recovery for 30 seconds.
Main outcome variables
FVC, FEV1, oxygen saturation, dyspnea, health-related quality of life, Interleukin 8, TNF-α

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210813052172N2
Registration date: 2023-01-16, 1401/10/26
Registration timing: prospective

Last update: 2023-01-16, 1401/10/26
Update count: 0
Registration date
2023-01-16, 1401/10/26
Registrant information
Name
Masoumeh ZoghAli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3662 4225
Email address
masoumezoghali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of high intensity interval training, interval training and continuous training on systemic inflammatory and respiratory factors in patients with chronic obstructive pulmonary disease
Public title
The effect of high-intensity intermittent exercise, moderate-intensity intermittent exercise and continuous exercise in patients with chronic obstructive pulmonary disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COPD grades 2 and 3 Age between 20-70 years
Exclusion criteria:
Moderate to severe learning difficulties Mobility problems Confusion Disorientation or terminal illness Congestive heart failure
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple. Randomization Unit: Individual. Randomization tool: table of random numbers. Based on the codes assigned to each patient (using the file number), the patients are divided into 4 groups under the desired treatments.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done for patients and laboratory technician. A rehabilitation person who is a physiotherapist cannot be blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi St, Shahid Yemeni St., Chamran Highway,
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2022-11-27, 1401/09/06
Ethics committee reference number
IR.SBMU.NRITLD.REC.1401.097

Health conditions studied

1

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

Primary outcomes

1

Description
Maximum expiratory volume in the first second
Timepoint
Before and after exercises
Method of measurement
Spirometry

2

Description
FVC
Timepoint
Before and after exercises
Method of measurement
Spirometry

3

Description
Oxygen saturation
Timepoint
Before and after exercises
Method of measurement
Pulse oximetry

4

Description
Dyspnea
Timepoint
Before and after exercises
Method of measurement
Borg scale

Secondary outcomes

1

Description
Interleukin 8
Timepoint
Before and after exercises
Method of measurement
ELISA test

2

Description
TNF-α
Timepoint
Before and after exercises
Method of measurement
ELISA test

Intervention groups

1

Description
Intervention group: Patients perform high-intensity intermittent exercises with a duration of 4 hours and a recovery period of 3 minutes.
Category
Rehabilitation

2

Description
Intervention group: Patients perform high-intensity intermittent exercises for 2 minutes of activity and 1 minute of recovery.
Category
Rehabilitation

3

Description
Intervention group: Patients perform high-intensity intermittent exercises, activity diversion for 30 seconds and recovery diversion for 30 seconds.
Category
Rehabilitation

4

Description
Control group: Patients do moderate intensity continuous exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Masoumeh Zoghali
Street address
Masih Daneshvari Hospital, Daar Abad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
masoumezoghali@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
Arabi St, Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
198396411
Phone
+98 21 2243 9781
Email
Mpajouhesh@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
Masoumeh Zoghali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Masih Daneshvari Hospital, Daar Abad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
masoumezoghali@gmail.com

Person responsible for scientific 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, Daar Abad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
mohsenabedi110@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
Biotechnology
Street address
Masih Daneshvari Hospital, Daar Abad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
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
Not applicable
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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