Breathing ExercisesNCT06303479
The Effect of Telerehabilitation-Based Respiratory Exercise Programs on Lung Capacity
A study testing Non-Instrumental breathing exercise group and Instrumental breathing exercise group in people with Breathing Exercises and Telerehabilitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises, Telerehabilitation
- What is being tested?
- Non-Instrumental breathing exercise group and Instrumental breathing exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2024to 29 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female/male young adult between the ages of 18-30 December,
- Who volunteered to participate in the study,
- Without a known disease
- Volunteers who do not have psychological, cognitive and emotional problems
Who cannot join
- Cigarette and alcohol users
- People with severe cardiopulmonary disorders
- People with postural disorders (such as scoliosis,kyphosis...)
- Unstable angina, has it been recently, pulmonary embolism
- People with obesity/diabetes
- Mental or cognitive impairment that will affect mental cooperation
Show all 9Show fewer
- People with severe nausea, vomiting attacks
- People with dyspnea
- People with orthopedic disorders that will affect exercise performance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul
Esra PEHLİVAN, Assoc. Dr., +90 212 409 02 00, esra.pehlivan@sbu.edu.tr
Esra PEHLİVAN, Assoc. Prof.
About this study
Official title: The Effect of Telerehabilitation-Based Breathing Exercise Programs With and Without Instruments on Lung Capacity
It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;
- Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,
- It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment.
Read more
In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly.
Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants.
Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated.
Read the detailed description
Breathing exercises are one of the components of pulmonary rehabilitation that have been widely used in clinical practice for many years. Exercises such as pursed lip breathing, local expansion, diagraphmatic breathing, holding at maximum inspiration are some of the breathing exercises in the literature. Such breathing exercises dilate the airways, facilitate gas exchange in the alveoli, increase the amount of oxygen reaching the cells, and normalize respiratory functions. Diaphragmatic breathing is a technique that uses the contraction of the diaphragm muscle to increase the length of the diaphragm and the efficiency of breathing, resulting in more efficient expiration. Studies have shown that diaphragmatic breathing reduces respiratory workload and dyspnea, increases respiratory efficiency and exercise tolerance, and improves minute ventilation by reducing the number of breaths. The aim of respiratory exercises is to maintain and improve respiratory function and to increase the amount of air entering and leaving the lungs. The amount of incoming and outgoing air is called lung volume and capacity. Lung volumes and capacities; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), Tiffeneau index (FEV1\FVC), peak expiratory flow (PEF) will be compared.
There are also many therapeutic devices developed among respiratory exercises. The incentive spirometer is one of these exercise devices. The incentive spirometer can be used for two different purposes: volume-oriented or flow-oriented. Studies have shown that volume-oriented devices are more effective in improving respiratory parameters than flow-oriented devices. In the literature, it is stated that the use of spirometers increases lung capacities, provides more comfortable air entry into the alveoli and facilitates gas exchange.
Telerehabilitation method is defined as the remote delivery of rehabilitation services by rehabilitation specialists with certain procedures and protocols using tools such as information and communication technologies. With telerehabilitation, it is aimed to follow patients at home, to carry rehabilitation services far away and to provide health services directly where the patient is.
In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. In the literature, there is no study comparing the efficacy of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on healthy young adults. Thus, this project will contribute to the literature and will be a preliminary study for advanced research in this field.
- Conditions
- Breathing Exercises, Telerehabilitation
- Being tested
- Non-Instrumental breathing exercise group, Instrumental breathing exercise group
- Keywords
- spirometry, physical activity, lung volume
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Instrumental breathing exercise groupOther
Before starting the exercises, participants will be told about diaphragmatic breathing exercises, maximum inspiratory holding technique and thoracic expansion exercises through the Zoom program by telerehabilitation method, and people will be checked by the physiotherapist who manages the program during the practice. The program will last for 8 weeks and will be planned to be implemented 5 days a week in total, including 2 days of telerehabilitation, 3 days of home program. The participant will be asked to start the exercises in a reclining position with his back to the chair. He will be asked to place his right hand on his upper abdomen and his left hand on the upper side of his chest. In each session, the exercises will be performed with 1 set of 10 repetitions for each of the diaphragmatic breathing and thoracic expansion exercises and will progress with progression.
Instrumental breathing exercise groupOther
The volume-oriented spirometer works with pressure and its indicator changes during breathing. When the participants breathe, the pressure in the tube decreases and the piston of the spirometer rises. The inhaled breath volume is seen at the top of the piston. In our study, participants will be told about the exercises through the Zoom program using the telerehabilitation method, and people will be checked by the responsible physiotherapist who manages the program during the application. The program will last for 8 weeks, 2 days of telerehabilitation, 3 days of home program will be planned to be implemented 5 days a week in total. Participants will be instructed to breathe up to their total lung capacity and maintain continuous inspiration for at least 3 seconds. The exercises will start with 1 set of 15 repetitions and the program will progress with progression.
| Study group | Role | What they receive |
|---|---|---|
| Instrumental breathing exercise group | Experimental | Instrumental breathing exercise group consisting of 13 healthy adults between the ages of 18-30 Receives: Other: Instrumental breathing exercise group |
| Non-Instrumental breathing exercise group | Experimental | Non-Instrumental breathing exercise group consisting of 13 healthy adults between the ages of 18-30 Receives: Other: Non-Instrumental breathing exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test for FEV1
Pulmonary function test will be performed with desktop type spirometry. The FEV1 value will be calculated.
Measured: At baseline and 8 weeks
Pulmonary Function Test for PEF
Pulmonary function test will be performed with desktop type spirometry. The PEF value will be calculated.
Measured: At baseline and 8 weeks
Pulmonary Function Test for FEV1/FVC
Pulmonary function test will be performed with desktop type spirometry. The FEV1/FVC value will be calculated.
Measured: At baseline and 8 weeks
Pulmonary Function Test for FVC
Pulmonary function test will be performed with desktop type spirometry. The FVC value will be calculated.
Measured: At baseline and 8 weeks
Secondary outcomes (1)
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
IPAQ-SF is a form designed to measure physical activity among individuals. It includes leisure time physical activities, home and garden activities, work-related physical activities, transportation-related physical activities. Physical activity status will be determined by this questionnaire.
Measured: At baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completion29 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma Nur AYYILDIZ, Student, Study chair, Saglik Bilimleri UniversitesiBeyzanur YEŞİLYURT, Student, Study chair, Saglik Bilimleri UniversitesiFulya KARAAHMETOĞLU, PhD (c), Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303479
- Sponsor's protocol ID
- Voldyne_Tele
- Status last verified
- Dec 2023
- First submitted
- 26 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation-Based Breathing Exercise Programs With and Without Instruments on Lung Capacity
- ClinicalTrials.gov ID
- NCT06303479
- Acronym / sponsor ID
- Voldyne_Tele
- Conditions
- Breathing Exercises, Telerehabilitation
- Keywords
- spirometry, physical activity, lung volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- 29 Sep 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;
- Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,
- It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment.
In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly.
Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants.
Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated.
Detailed description
Breathing exercises are one of the components of pulmonary rehabilitation that have been widely used in clinical practice for many years. Exercises such as pursed lip breathing, local expansion, diagraphmatic breathing, holding at maximum inspiration are some of the breathing exercises in the literature. Such breathing exercises dilate the airways, facilitate gas exchange in the alveoli, increase the amount of oxygen reaching the cells, and normalize respiratory functions. Diaphragmatic breathing is a technique that uses the contraction of the diaphragm muscle to increase the length of the diaphragm and the efficiency of breathing, resulting in more efficient expiration. Studies have shown that diaphragmatic breathing reduces respiratory workload and dyspnea, increases respiratory efficiency and exercise tolerance, and improves minute ventilation by reducing the number of breaths. The aim of respiratory exercises is to maintain and improve respiratory function and to increase the amount of air entering and leaving the lungs. The amount of incoming and outgoing air is called lung volume and capacity. Lung volumes and capacities; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), Tiffeneau index (FEV1\FVC), peak expiratory flow (PEF) will be compared.
There are also many therapeutic devices developed among respiratory exercises. The incentive spirometer is one of these exercise devices. The incentive spirometer can be used for two different purposes: volume-oriented or flow-oriented. Studies have shown that volume-oriented devices are more effective in improving respiratory parameters than flow-oriented devices. In the literature, it is stated that the use of spirometers increases lung capacities, provides more comfortable air entry into the alveoli and facilitates gas exchange.
Telerehabilitation method is defined as the remote delivery of rehabilitation services by rehabilitation specialists with certain procedures and protocols using tools such as information and communication technologies. With telerehabilitation, it is aimed to follow patients at home, to carry rehabilitation services far away and to provide health services directly where the patient is.
In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. In the literature, there is no study comparing the efficacy of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on healthy young adults. Thus, this project will contribute to the literature and will be a preliminary study for advanced research in this field.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrumental breathing exercise group | Experimental | Other: Instrumental breathing exercise groupInstrumental breathing exercise group consisting of 13 healthy adults between the ages of 18-30 |
| Non-Instrumental breathing exercise group | Experimental | Other: Non-Instrumental breathing exercise groupNon-Instrumental breathing exercise group consisting of 13 healthy adults between the ages of 18-30 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female/male young adult between the ages of 18-30 December,
- Who volunteered to participate in the study,
- Without a known disease
- Volunteers who do not have psychological, cognitive and emotional problems
Key exclusion criteria (9 listed)
- Cigarette and alcohol users
- People with severe cardiopulmonary disorders
- People with postural disorders (such as scoliosis,kyphosis...)
- Unstable angina, has it been recently, pulmonary embolism
- People with obesity/diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Instrumental breathing exercise groupBefore starting the exercises, participants will be told about diaphragmatic breathing exercises, maximum inspiratory holding technique and thoracic expansion exercises through the Zoom program by telerehabilitation method, and people will be checked by the physiotherapist who manages the program during the practice. The program will last for 8 weeks and will be planned to be implemented 5 days a week in total, including 2 days of telerehabilitation, 3 days of home program. The participant will be asked to start the exercises in a reclining position with his back to the chair. He will be asked to place his right hand on his upper abdomen and his left hand on the upper side of his chest. In each session, the exercises will be performed with 1 set of 10 repetitions for each of the diaphragmatic breathing and thoracic expansion exercises and will progress with progression. | Other | Non-Instrumental breathing exercise group |
| Instrumental breathing exercise groupThe volume-oriented spirometer works with pressure and its indicator changes during breathing. When the participants breathe, the pressure in the tube decreases and the piston of the spirometer rises. The inhaled breath volume is seen at the top of the piston. In our study, participants will be told about the exercises through the Zoom program using the telerehabilitation method, and people will be checked by the responsible physiotherapist who manages the program during the application. The program will last for 8 weeks, 2 days of telerehabilitation, 3 days of home program will be planned to be implemented 5 days a week in total. Participants will be instructed to breathe up to their total lung capacity and maintain continuous inspiration for at least 3 seconds. The exercises will start with 1 set of 15 repetitions and the program will progress with progression. | Other | Instrumental breathing exercise group |
Primary outcome
Pulmonary Function Test for FEV1
Time frame: At baseline and 8 weeks
Pulmonary function test will be performed with desktop type spirometry. The FEV1 value will be calculated.
Pulmonary Function Test for PEF
Time frame: At baseline and 8 weeks
Pulmonary function test will be performed with desktop type spirometry. The PEF value will be calculated.
Pulmonary Function Test for FEV1/FVC
Time frame: At baseline and 8 weeks
Pulmonary function test will be performed with desktop type spirometry. The FEV1/FVC value will be calculated.
Pulmonary Function Test for FVC
Time frame: At baseline and 8 weeks
Pulmonary function test will be performed with desktop type spirometry. The FVC value will be calculated.
1 secondary outcome
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: At baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Nur AYYILDIZ, Student study chair
Saglik Bilimleri Universitesi
Beyzanur YEŞİLYURT, Student study chair
Saglik Bilimleri Universitesi
Fulya KARAAHMETOĞLU, PhD (c) study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Instrumental breathing exercise group and Instrumental breathing exercise group in people with Breathing Exercises and Telerehabilitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa ÇÖRTÜK, Prof.Dr. (+90 212 409 02 00, mustafa.cortuk@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test for FEV1 (time frame: At baseline and 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.