To evaluate the effectiveness of inspiratory muscle training on inspiratory muscle strength, dynamic balance and sports performance in sub-elite athletes.
Design
Thirty-two sub-elite athletes who have a chest breathing pattern are divided into two intervention groups (inspiratory muscle training) and control group in a simple random manner and using a sealed envelope. The study is a single-blind clinical trial.
Settings and conduct
Breathing with natural respiratory mechanics plays an important role in the neuromuscular-skeletal system, which is often neglected in athletes. The present study aims to investigate the effect of inspiratory muscle training on inspiratory muscle strength, dynamic balance, sports performance, core stability, chest expansion and spinal curvatures in sub-elite athletes. The study is a single-blind study (therapist and evaluator).
Participants/Inclusion and exclusion criteria
Sub-elite athletes (18-35 years old) with chest breathing pattern will be included in the study. which do not have musculoskeletal injuries, neurological diseases, cardio-pulmonary and vascular diseases and other abnormalities that make our research evaluations impossible. Absence of more than 20% in training sessions during the intervention period will cause participants to be excluded from the study.
Intervention groups
Group A received inspiratory muscle training for 6 weeks and Group B did not receive any other intervention other than professional training related to their sport.
Main outcome variables
Inspiratory Muscle Strength; Dynamic Balance; Core stability and Sports Performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240312061267N1
Registration date:2024-04-13, 1403/01/25
Registration timing:prospective
Last update:2024-04-13, 1403/01/25
Update count:0
Registration date
2024-04-13, 1403/01/25
Registrant information
Name
Iran Kalbali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 3892
Email address
zkalbali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Inspiratory Muscle Training on Inspiratory Muscle Strength, Dynamic Balance and Sports Performance in Sub-elite Athletes
Public title
The Effect of Inspiratory Training on Performance in Sub-elite Athletes: A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 35 years
Participants are selected from sub-elite athletes.
Having a chest breathing pattern.
No musculoskeletal injuries and complications such as disc herniation, osteoporosis, spondylolisthesis, degenerative changes of the spine, severe scoliosis, fractures in the spine and injuries of the lower limbs in the last 6 months or during the study.
No neurological diseases such as multiple sclerosis.
No cardiopulmonary, vascular and diseases.
No abnormalities in other systems that make our research evaluations impossible, such as uncorrected vestibular and visual disorders and uncorrected.
No history of surgery in the back, abdomen or chest area.
No diabetes and uncontrolled high blood pressure.
Not being a smoker or quitting smoking at least 6 months before the study.
Not being overweight
Exclusion criteria:
More than 20% absence in practice sessions during the intervention period.
Unwillingness to continue the intervention sessions
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using a random allocation software and concealment of random allocation will be done by sequentially numbered, opaque, sealed envelopes. In this method, after assigning a random sequence, a number of opaque envelopes are prepared and each of the created random sequences is recorded on a card, and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. The random allocation process will be done by someone outside of the research team before the start of the study. Finally, the participants are divided into two groups, A (intervention group) and B (control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind study so that the evaluations and treatment will be done by two separate physiotherapists. The evaluator is blinded to the study group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.TUMS.FNM.REC.1402.237
Health conditions studied
1
Description of health condition studied
Athletes with chest breathing pattern
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Inspiratory muscle strength
Timepoint
Before the start of the intervention and after the last session of the intervention
Method of measurement
Measurement of maximum dynamic inspiratory pressure by PowerBreathe device
2
Description
Dynamic balance
Timepoint
Before the start of the intervention and after the last session of the intervention
Method of measurement
Y Balance Test
3
Description
Core stability
Timepoint
Before the start of the intervention and after the last session of the intervention
Method of measurement
Prone Plank Test
4
Description
Sports performance
Timepoint
Before the start of the intervention and after the last session of the intervention
Method of measurement
Charbonneau questionnaire
Secondary outcomes
1
Description
Chest expansion
Timepoint
Before the start of the intervention and after the last session of the intervention
Method of measurement
Tape measure
2
Description
Spinal curvatures
Timepoint
Before the start of the intervention and after the last session of the intervention
Method of measurement
Flexible ruler
Intervention groups
1
Description
Intervention group: Group A: for 6 weeks and 3 days a week (18 sessions), they will be subjected to the intervention of breathing exercises using the POWERbreathe device (POWERbreathe K-5; International Ltd, England, United Kingdom). Each training session will include a 5-minute warm-up (15% maximal inspiratory pressure (MIP)) and two sets of 15 repetitions of breathing with an interval of 1 minute, and this program will be repeated once more with an interval of 5 minutes (a total of 4 sets of 15 repetition) and at the end, 5 minutes of cooling with 15% MIP is done. The training load in the first week of the research is 50% MIP and 10% is added every week to reach 100% MIP in the sixth week. At the end of each training week, the MIP will be reassessed and the training load will be adjusted accordingly.
Category
Rehabilitation
2
Description
Control group: Participants in group B (control group) do not receive any other intervention other than their professional training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Dr Sara Fereydounnia
Street address
Vice Chancellor for Research and Technology, Central University Organization, Corner of Ghods St. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7752 8468
Email
s-fereydounnia@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Vice Chancellor for Research, sixth Floor, Central University Organization, Corner of Ghods St. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zinat Kalbali
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
zkalbali@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sara Fereydounnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
s-fereydounnia@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zinat Kalbali
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
zkalbali@razi.tums.ac.ir
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
Yes - There is a plan to make this available
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 data is potentially shareable after unidentified individuals.
When the data will become available and for how long
The access period starts 3 months after the articles are published.
To whom data/document is available
For researchers working in academic, scientific, hospital institutions and clinicians.
Under which criteria data/document could be used
Researchers who work in the field of respiratory physiotherapy and musculoskeletal disorders rehabilitation.
From where data/document is obtainable
Applicants for documentation can contact Ms. Zinat Kalbali via email. zkalbali@razi.tums.ac.ir
What processes are involved for a request to access data/document
Once they have the necessary criteria, the information will be provided to them within a month.