Protocol summary

Study aim
The effect of different interval training protocols on the clinical and cardiorespiratory index in patients with COPD
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 48 patients.
Settings and conduct
This study is conducted as a clinical trial on patients with COPD referred to Masih Deneshvari Hospital in Tehran. Patients who meet the inclusion criteria will be placed in one of the three study groups after providing full explanations and signing a written consent form.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: COPD patients in Grades 2, 3, and 4, age over 18 years. Exclusion criteria: Patient dissatisfaction to participate in the study, underlying diseases such as diabetes, nervous system diseases affecting cardiac rhythm
Intervention groups
In the first intervention group, after warming up, the patients perform 30 seconds of activity with an intensity of 85% of the maximum oxygen peak, then they perform 30 seconds of recovery with 40% of the maximum oxygen peak. Patients will have 4 minutes of passive recovery after doing 8 sets. After 4 minutes of recovery, they will perform the same as above for another 8 minutes. After finishing the activity, the patients will perform cooling movements for 5 minutes. The second group also performs peak oxygen for 4 minutes with 85% intensity after 5 minutes of warming up. Then they perform 3 minutes of recovery with 40% of the maximum oxygen peak. Patients perform this protocol in 3 sets for 21 minutes. The third group (control group) received only routine treatments and did not receive any exercise intervention. The total duration of the rehabilitation process will be 2 weeks.
Main outcome variables
Six-minute walk test distance, resting oxygen saturation, anaerobic threshold VO2, maximum heart rate, maximum VO2, SDRR, RMSSD, HF, LF, LF/HF

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200611047727N6
Registration date: 2023-03-14, 1401/12/23
Registration timing: prospective

Last update: 2023-03-14, 1401/12/23
Update count: 0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Maryam Sadat Mirenayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 5050
Email address
mirenayat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of interval exercises on heart rate variability in hospitalized patients with chronic obstructive pulmonary disease (COPD)
Public title
The effect of various types of interval exercises in patients with COPD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COPD in Grade 2, 3 and 4 Age more than 18
Exclusion criteria:
Dissatisfaction to participate in the study Underlying diseases such as diabetes Nervous system diseases affecting cardiac rhythm
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, individual randomization unit and random number table randomization tool. For randomization, we use a table consisting of random digits from 0 to 9. Each of the figures in this table is repeated the same on average. We start from the first row of the table and move down row by row. For three treatments, we put numbers 1 to 3 for treatment A, numbers 4 to 6 for treatment B, and numbers 7 to 9 for treatment C. We continue the above process until three groups are completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to prevent any possible complications, the doctor and clinical caregiver are fully aware of the assignment of treatment groups. Researchers responsible for data collection and analysis are not aware of the allocation of different study groups.
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
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.SBMU.NRITLD.REC.1401.134

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Distance of 6-minute walk test
Timepoint
Before rehabilitation and 2 week after rehabilitation
Method of measurement
6-minute walk test

2

Description
Resting heart rate
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Cardiopulmonary exercise test

3

Description
VO2 at anaerobic threshold
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Cardiopulmonary exercise test

4

Description
Maximum heart rate
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Cardiopulmonary exercise test

5

Description
VO2 max
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Cardiopulmonary exercise test

6

Description
Standard deviation of ventricular contraction wave period
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Heart rate variability holter

7

Description
The root mean square of successive differences between normal heartbeats
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Heart rate variability holter

8

Description
High frequency
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Heart rate variability holter

9

Description
Low frequency
Timepoint
Before rehabilitation and 2 weeks after rehabilitation
Method of measurement
Heart rate variability holter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After warming up, the patients do 30 seconds of activity with an intensity of 85% of the maximum oxygen peak, then they do 30 seconds of recovery with 40% of the maximum oxygen peak. Patients will have passive recovery after doing 8 sets of 4 minutes. After 4 minutes of recovery, they will perform the same as above for another 8 minutes. After finishing the activity, the patients will perform cooling movements for 5 minutes.
Category
Rehabilitation

2

Description
Intervention group: After warming up for 5 minutes, the patients perform 4 minutes with an intensity of 85% of the maximum oxygen peak. Then they perform 3 minutes of recovery with 40% of the maximum oxygen peak. Patients perform this protocol in 3 sets for 21 minutes.
Category
Rehabilitation

3

Description
Control group: Patients receive only routine treatments and no exercise intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Maryam Sadat Mirenayat
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2612 5050
Email
MirenayaT_M@yahoo.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
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2243 9781
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, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 2020
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
Arezoo Mohamadifar
Position
Non-faculty specialist doctor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 2020
Email
arezoomohamadifar@yahoo.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, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 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
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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