Investigating the effect of Telerehabilitation exercises on quality of life, balance, functional disability, aerobic capacity and pain in elderly chemical veterans
The effect of Telerehabilitation exercises on quality of life, balance, functional disability, aerobic capacity and pain in elderly chemical veterans
Design
A controlled clinical trial with parallel groups, unblinded, randomized, on 32 samples. The Excel RAND function is used for randomization.
Settings and conduct
Health and medical centers in Tehran, Iran. Subjects entered the study according to the inclusion criteria and filled out an informed consent form. Pre-test was administered to all subjects. Subjects were divided into two intervention and control groups. The eighth week of intervention was conducted and at the end, all subjects were given a post-test.
Participants/Inclusion and exclusion criteria
Elderly male chemical warfare veterans with a proven history of exposure to mustard gas during chemical bombing and a history of moderate to severe chronic pulmonary disease
Intervention groups
The intervention group's exercise program includes warm-up, aerobic exercises, strength exercises, balance and flexibility exercises, relaxation and cool-down. Exercises will be provided three days a week for 8 weeks and via web-based platforms such as Telegram or WhatsApp. Each exercise will be performed by the researcher personally, then the video of this performance will be made available to the subjects. After each exercise session, the subjects will send the video of the exercise performance to the researcher. During this time, the control group will continue their normal daily activities. They are allowed to do light activities such as slow walking or housework but should not participate in any structured rehabilitation program. Weekly monitoring will be done via phone call and if interventions similar to the main intervention are started, the subject's continued participation in the study will be reviewed.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100505003871N4
Registration date:2025-10-22, 1404/07/30
Registration timing:prospective
Last update:2025-10-22, 1404/07/30
Update count:0
Registration date
2025-10-22, 1404/07/30
Registrant information
Name
Alireza Shamsoddini
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3353
Email address
alirezaot@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Telerehabilitation exercises on quality of life, balance, functional disability, aerobic capacity and pain in elderly chemical veterans
Public title
Investigating the effect of Telerehabilitation exercises in elderly chemical veterans
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male chemical veterans over 60 years of age with a proven history of exposure to mustard gas
Participants must have moderate to severe chronic lung disease.
Exclusion criteria:
Participants had a history of tuberculosis or resection of 1 or more lung lobes.
No history of exposure to mustard gas is recorded in the Veterans Foundation's medical file.
Age
From 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize participants into two groups, control and intervention, a block randomization method will be used with the help of Excel software. The allocation sequence will be generated with the help of the software's random functions (RAND) and participants will be placed equally and randomly in two groups in blocks of four. The final allocation will be made by someone outside the implementation team and through prepared lists to prevent any bias. Measures will be taken to control and reduce possible measurement errors in the pre-test and post-test stages. All tests will be performed by a fixed and trained examiner to prevent errors.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bagheiat-allah University of Medical sciences
Street address
Sports Physiology Research Institute, Bagheiat-allah University of Medical sciences, South Sheikh Bahai St., Molla Sadra St.
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2025-10-06, 1404/07/14
Ethics committee reference number
IR.BMSU.REC.1404.089
Health conditions studied
1
Description of health condition studied
Chronic complications of chemical warfare exposure (elderly chemical veterans)
ICD-10 code
T59.4
ICD-10 code description
Toxic effect of chlorine gas
Primary outcomes
1
Description
Comparison of Quality-of-life scores in the control and intervention groups
Timepoint
At baseline and after eight weeks of intervention
Method of measurement
SF-36 Quality of Life Questionnaire
Secondary outcomes
1
Description
Comparison of balance scores in the control and intervention groups
Timepoint
At baseline and after eight weeks of intervention
Method of measurement
Sharpened Romberg Test
2
Description
Comparison of functional disability scores in the control and intervention groups
Timepoint
At baseline and after eight weeks of intervention
Method of measurement
Oswestry Disability Index
3
Description
Comparison of aerobic capacity scores in the control and intervention groups
Timepoint
At baseline and after eight weeks of intervention
Method of measurement
6-Minute Walk Test
4
Description
Comparison of pain scores in the control and intervention groups
Timepoint
At baseline and after eight weeks of intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The group's exercises will be performed three days a week for 8 weeks. The video exercise program will be provided through web-based platforms such as Telegram or WhatsApp. First, the researcher will perform each exercise personally and provide the necessary explanations during the exercise. Then, the video of this performance will be made available to the subjects, and after each exercise session, the subjects will send the video of the exercise performance to the researcher. The exercise program of the intervention group will include the following steps: Warm-up (5-7 minutes) / Aerobic exercises (10-12 minutes) / Strength exercises (10-12 minutes) / Balance and flexibility exercises (8-10 minutes) / Relaxation and cooling down (3-5 minutes). Participants are required to complete the weekly monitoring form. This form includes the following: Days of exercise / Type of exercise performed (aerobic, strength, balance, stretching) Approximate duration of exercise / Physical feeling after exercise (comfort, fatigue, pain, etc.) Obstacles or problems in performing the exercises. Participation in at least 75% of training sessions is considered acceptable adherence.
Category
Rehabilitation
2
Description
Control group: During the eight-week intervention, participants in the control group will continue their normal daily activities. They are allowed to do light activities such as walking or housework but should not participate in any structured exercise or rehabilitation program. Weekly monitoring will be done by telephone, and if interventions similar to the main intervention are initiated, the subject's continued participation in the study will be reviewed.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatullah Hospital
Full name of responsible person
Alireza Shamsodini
Street address
Sports Physiology Research Institute, Bagheiat-allah University of Medical Sciences, South Sheikh Bahai St., Molla Sadra St.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 990 711 6379
Email
alirezaot@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abbas Ali Imani Fouladi
Street address
Sports Physiology Research Institute, Bagheiat-allah University of Medical Sciences, South Sheikh bahai St., Mollla Sadra St.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
eprc.webinar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Sports Physiology Research Institute, Bagheiat-allah University of Medical Sciences, South Sheikh bahai St., Mollla Sadra St.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3353
Fax
+98 21 8862 0843
Email
alirezaot@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Sports Physiology Research Institute, Bagheiat-allah University of Medical Sciences, South Sheikh bahai St., Mollla Sadra St.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3353
Fax
+98 21 8862 0843
Email
alirezaot@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Sports Physiology Research Institute, Bagheiat-allah University of Medical Sciences, South Sheikh bahai St., Mollla Sadra St.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3353
Fax
+98 21 8862 0843
Email
alirezaot@bmsu.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Results from the analysis of participant data, both primary and secondary outcomes, will be published.
When the data will become available and for how long
Access to the data will be possible after the publication of the article.
To whom data/document is available
Researchers of academic and scientific centers could access the data.
Under which criteria data/document could be used
Analyzes that do not overlap with the objectives of the present study will be allowed
From where data/document is obtainable
Dr. Alireza Shamsoddini Email: shamseddin23@gmail.com
What processes are involved for a request to access data/document
The requester could access the data by providing the research area as well as the purpose of accessing the data