Protocol summary

Study aim
Comparison of the effect of continuous and interval exercise on respiratory and inflammatory indicators of patients with Interstitial lung disease (ILD) candidates for lung transplantation
Design
Clinical trial with a control group, with parallel groups, a blinded, randomized, phase 3 on 30 patients, random number table and individual randomization unit were used for randomization.
Settings and conduct
This study is a blind strain and only the researchers responsible for data collection and analysis are not aware of the allocation of groups. A total of 30 patients referred to Masih Deneshvari Hospital in Tehran, Iran will be evaluated. Control group patients do 30 minutes of continuous exercises (treadmill) with 60% of the maximum exercise capacity. In the intervention group, interval exercises include 2 minutes of activity with an intensity of 80% of the maximum exercise capacity, and 2 minutes of recovery with an intensity of 50% (by treadmill). The duration of the exercises will be 30 minutes and over a period of 10 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age above 18, consent to participate in the study, BMI in the range of 19-25, muscle force of hip flexors and knee extensors at least 4 out of 5, and patients undergoing oxygen therapy. Exclusion criteria include having pulmonary hypertension, PAP above 40, musculoskeletal problems limiting exercise.
Intervention groups
Patients in the control group perform 30 minutes of continuous exercises (treadmill) with 60% of the maximum exercise capacity. In the intervention group, interval exercises include 2 minutes of activity with an intensity of 80% of the maximum exercise capacity, and 2 minutes of recovery with an intensity of 50%. (by treadmill).
Main outcome variables
Maximum exercise capacity, quality of life, shortness of breath and fatigue, PIMAX and PEMAX, DLCO, FEV1, FVC, CRP, ESR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160516027929N12
Registration date: 2023-01-21, 1401/11/01
Registration timing: prospective

Last update: 2023-01-21, 1401/11/01
Update count: 0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Atefeh Fakharian
Name of organization / entity
National research institute of tuberculosis and lung diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2541
Email address
afakharian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of continuous and interval exercise on respiratory and inflammatory indicators of patients with Interstitial lung disease (ILD) candidates for lung transplantation
Public title
Comparison of continuous and intermittent exercise in patients with interstitial lung disease (ILD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 Consent to participate in the study BMI in the range of 19 to 25 Muscle force of hip flexors and knee extensors at least 4 out of 5 Patients under oxygen therapy
Exclusion criteria:
Pulmonary hypertension PAP above 40 Musculoskeletal problems limiting exercise
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done with a simple randomization method using a table of random numbers and an individual randomization unit. For randomization, we use a table consisting of random numbers 1 to 8. Each of the figures in this table is repeated the same on average. There is no discernible pattern of numerical values. In this method, each figure is assigned to a treatment group. We start from the first row of the table and move down row by row. For the two treatments that will be performed, we put numbers 1 to 4 for treatment A and numbers 5 to 8 for treatment B. We continue the above process until two groups are complete.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blind strain and in order to prevent any kind of possible complications, the specialist doctor and the clinical caregiver are fully aware of the specialty of the treatment groups. Patients participating in the study were not blinded to the type of treatment they received. Only the researchers responsible for data analysis are not aware of the allocation of different study groups. Patient information will be provided to the data analyst in coded form in separate files.
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
Next to Taleghani Hospital, Yemen Street , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.SBMU.NRITLD.REC.1401.107

Health conditions studied

1

Description of health condition studied
Interstitial lung disease (ILD)
ICD-10 code
J84.1
ICD-10 code description
Other interstitial pulmonary diseases with fibrosis

Primary outcomes

1

Description
PImax
Timepoint
The first day of training and the final day
Method of measurement
Body box

2

Description
PEmax
Timepoint
The first day of training and the final day
Method of measurement
Body box

3

Description
FEV1
Timepoint
The first day of training and the final day
Method of measurement
Spirometry

4

Description
FVC
Timepoint
The first day of training and the final day
Method of measurement
Spirometry

5

Description
TLC
Timepoint
The first day of training and the final day
Method of measurement
Spirometry

6

Description
Maximum sports capacity
Timepoint
The first day of training and the final day
Method of measurement
Six-minute walk test

7

Description
Shortness of breath
Timepoint
The first day of training and the final day
Method of measurement
Based on the Borg scale

8

Description
CRP
Timepoint
The first day of training and the final day
Method of measurement
Evaluation of laboratory tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, interval exercises include 2 minutes of activity with an intensity of 80% of the maximum exercise capacity, and 2 minutes of recovery with an intensity of 50% (by treadmill). Before starting their exercise program, patients do 5 minutes of warm-up exercises with an intensity of 70% of the maximum HR and at the end, they will do a 5-minute cool-down exercise with an intensity of 20-30% of the maximum HR. The duration of the exercises will be 30 minutes and over a period of 10 days.
Category
Rehabilitation

2

Description
Control group: Patients in the control group perform 30 minutes of continuous exercises (treadmill) with 60% of maximum exercise capacity. Before starting their exercise program, patients perform 5 minutes of warm-up exercises with an intensity of 70% of maximum HR and at the end, cool down exercises for 5 minutes. They will do 20-30% maximum HR intensity for 30 minutes during 10 days.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Atefeh Fakharian
Street address
Masih Daneshvari Hospital, Daar Abad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2102
Email
fakharian_2005@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
Next to Taleghani Hospital, Yemen Street - Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
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
Atefeh Fakharian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Daar Abad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2201
Email
fakharian_2005@yahoo.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
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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