Pediatric CancerNCT06597552
The Effect of Inspiratory Muscle Training on Pediatric Cancer Patient
A study testing Training Group in people with Pediatric Cancer and Inspiratory Muscle Training, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of inspiratory muscle training on respiratory functions, functional capacity, fatigue and quality of life in pediatric cancer patients who have recently completed treatment. A total of 27 patients were included in the study. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Cancer, Inspiratory Muscle Training
- What is being tested?
- Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2019to 18 Aug 2023
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between 8 and 18 years old
- Having been diagnosed with cancer and having completed treatment
- Having passed at least 30 and at most 120 days after completion of treatment.
Who cannot join
- Having chronic lung disease,
- Having a history of hospitalization due to infection in the last month,
- Having a history of surgical intervention due to cancer,
- Having insufficient cognitive and cognitive functions,
- Having an orthopedic problem affecting mobility or a history of musculoskeletal surgical intervention,
- Having cancer relapse during the 8-week training program,
- Having received additional chemotherapy for any reason despite having completed treatment,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Inspiratory Muscle Training on Respiratory Functions, Functional Capacity, Failure and Quailty of Life in Pediatric Cancer Patient
The aim of this study is to examine the effects of inspiratory muscle training on respiratory functions, functional capacity, fatigue and quality of life in pediatric cancer patients who have recently completed treatment. A total of 27 patients were included in the study. The patients were divided into two groups as Training and Control groups. After the initial evaluation of all patients, they were included in an 8-week inspiratory muscle training program. The final evaluation was made at the end of 8 weeks. According to the final evaluations, it was found that there was a statistical increase in favor of the Training group on Maximal Inspiratory Pressure, 6 Minute Walking Test, Quality of Life and Fatigue.
Read the detailed description
The aim of this study is to investigate the effects of inspiratory muscle training on respiratory functions, functional capacity, fatigue and quality of life in pediatric cancer patients. A total of 27 patients, 13 in the training group and 14 in the control group, who received and completed cancer treatment at the Memorial Şişli Hospital Pediatric Oncology and Hematology Department and who met the inclusion criteria were included in the study. The age, gender, diagnosis, height and weight of the patients included in the study were recorded. Evaluations were made regarding respiratory functions, respiratory muscle strength, functional capacity, fatigue and quality of life in the patients before and after inspiratory muscle training.
In the study, the initial and post-training values of the FVC, % FVC, FEV1, % FEV1, FEV1/FVC, PEF and % PEF in the respiratory function test of the patients in the training and control groups were compared.
The MIP and MEP values of the patients in the training and control groups were compared with the initial and post-test values of SpO2, heart rate and walking distance calculated after 6MWT. Fatigue values of patients in the education and control groups before and after inspiratory muscle training were compared. Physical, emotional, social and school-related baseline values obtained after the pediatric quality of life test in the education and control groups were compared.
- Conditions
- Pediatric Cancer, Inspiratory Muscle Training
- Being tested
- Training Group, Control Group
- Keywords
- Pediatric Cancer, Inspiratory Muscle Training, Respiratory Function, Muscle Strength
- Medical subject headings
- Neoplasms, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training GroupOther
Also called Experimental Group
Inspiratory muscle training (IMT) was performed using the Threshold IMT device using the threshold loading method. The IMT was administered to the patients in the training group at 30% of the MIP value, 5 days a week, twice a day, for 15 minutes for 8 weeks. The patients in the training group were called for a check-up once a week and the MIP value was re-evaluated. The training workload for that week was determined by taking 30% of the new measured MIP value.
During the training, the patients were asked to sit with their upper body (shoulders and upper chest) in a relaxed position, and after the nose was closed with the clip, the mouthpiece of the device was tightly closed with the lips. While in this position, the patient was asked to inhale and exhale 5 times into the device, then remove the device from their mouth and listen for 5 breaths, and continue this cycle for 15 minutes.
Control GroupOther
The training intensity of the control group was given at the lowest load (9 cm H2O) for 8 weeks, five days a week, twice a day for 15 minutes. To eliminate the effect of learning, the MIP measure of the control group was measured once a week, but the intensity of the training was not increased during the 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: Control Group |
| Training Group | Experimental | Not described Receives: Other: Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Pulmonary Function
A spirometry device was used to evaluate lung functions and measurements were made according to ATS/ERS criteria. Before the test, the weight (kg), height (cm), age and gender values of the patients were recorded on the spirometry device. All measurements were made in a sitting position with the feet in full contact with the ground. A nose clip was used. At the beginning of the test, inspiration and expiration were requested within the limits of tidal volume. Then, the deepest possible inspiration was followed by rapid expiration. Care was taken to ensure that the expiration period continued uninterrupted for 6 seconds. The best of three tests that were 95% compatible with each other was selected and recorded. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), Tiffeneau ratio (FEV1/FVC) and peak expiratory volume (PEF) (L/min) values were measured and both the measured values and the percentages of expected values were recorded.
Measured: 8 weeks
Measurement of Respiratory Muscle Strength
Respiratory muscle strength was measured in accordance with ATS/ERS criteria using an electronic and portable intraoral pressure measuring device.All of the measurements were made in the sitting position with the feet in full contact with the ground. Nasal breathing was blocked with a nose clip. In order to measure the maximum inspiratory pressure (MIP), maximum expiratory maneuver was performed before the patient took the mouthpiece of the device into his mouth, and then maximal inspiration (Müller maneuver) was performed at maximum speed for 1-3 seconds. For maximum expiratory pressure measurement, the maximum inspiratory maneuver was performed before the mouthpiece of the device was taken into the mouth, and then maximal expiration (Valsalva maneuver) was performed at maximum speed for 1-3 seconds. 3 measurements were repeated for each evaluation and the highest value was recorded in "cmH2O".
Measured: 8 weeks
Measurement of Functional Capacity
Functional capacity was measured with the 6-Minute Walk Test (6MWT) according to the guideline of ERS. The 6MWT to be a reliable, reproducible, and valid functional test for assessing exercise tolerance and endurance. Subjects were instructed to walk from one end to the other of a 30 m hallway at their own pace, while attempting to cover as much ground as possible in the allotted 6 min. The test was self-paced and the subject could rest if he or she so wished.
Measured: 8 weeks
Measurement of Quality of Life
To determine the patients' quality of life, the Pediatric Quality of Life Scale (PedsQL 4.0), developed by Varni et al. and adapted into Turkish for the 8-12 age group by Sönmez and Başbakkal and its validity and reliability study was performed. The validity and reliability study of the 13-18 age group form of the scale was performed by Mermik et al. The total score that can be obtained from the 5-option Likert-type scale varies between 0 and 100, and scores closer to 0 indicate negative (bad) quality of life, while scores closer to 100 indicate positive (good) quality of life.
Measured: 8 weeks
Measurement of Fatigue
The Brief Fatigue Inventory (BFI), developed by Mendoza et al. for cancer patients and whose Turkish validity and reliability study was conducted by Çinar et al., was used to determine the fatigue levels of the participants. The inventory evaluates the fatigue level of the patients in the last 24 hours and its effect on daily life activities (general activity, mood, walking ability, work life, relationships with other people, joy of life). The inventory consists of a total of 9 items, 3 of which measure general fatigue and 6 of which evaluate the effect of fatigue on daily life. The evaluation of the items is made by summing the scores between "0" (no fatigue at all) and "10" (the most severe fatigue you can experience), with "0" being the lowest score and "90" being the highest score. A low score indicates a low fatigue level and a high score indicates a high fatigue level. In this study, the evaluation was made based on the total score obtained from the scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Mar 2019
- Primary completion12 Apr 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Onur Köksal, Medipol University
- Investigators
- Semiramis Özyılmaz, Assoc. Prof., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597552
- Sponsor's protocol ID
- 2019/001O
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Respiratory Functions, Functional Capacity, Failure and Quailty of Life in Pediatric Cancer Patient
- ClinicalTrials.gov ID
- NCT06597552
- Acronym / sponsor ID
- 2019/001O
- Conditions
- Pediatric Cancer, Inspiratory Muscle Training
- Keywords
- Pediatric Cancer, Inspiratory Muscle Training, Respiratory Function, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 19 Sep 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.
The aim of this study is to examine the effects of inspiratory muscle training on respiratory functions, functional capacity, fatigue and quality of life in pediatric cancer patients who have recently completed treatment. A total of 27 patients were included in the study. The patients were divided into two groups as Training and Control groups. After the initial evaluation of all patients, they were included in an 8-week inspiratory muscle training program. The final evaluation was made at the end of 8 weeks. According to the final evaluations, it was found that there was a statistical increase in favor of the Training group on Maximal Inspiratory Pressure, 6 Minute Walking Test, Quality of Life and Fatigue.
Detailed description
The aim of this study is to investigate the effects of inspiratory muscle training on respiratory functions, functional capacity, fatigue and quality of life in pediatric cancer patients. A total of 27 patients, 13 in the training group and 14 in the control group, who received and completed cancer treatment at the Memorial Şişli Hospital Pediatric Oncology and Hematology Department and who met the inclusion criteria were included in the study. The age, gender, diagnosis, height and weight of the patients included in the study were recorded. Evaluations were made regarding respiratory functions, respiratory muscle strength, functional capacity, fatigue and quality of life in the patients before and after inspiratory muscle training.
In the study, the initial and post-training values of the FVC, % FVC, FEV1, % FEV1, FEV1/FVC, PEF and % PEF in the respiratory function test of the patients in the training and control groups were compared.
The MIP and MEP values of the patients in the training and control groups were compared with the initial and post-test values of SpO2, heart rate and walking distance calculated after 6MWT. Fatigue values of patients in the education and control groups before and after inspiratory muscle training were compared. Physical, emotional, social and school-related baseline values obtained after the pediatric quality of life test in the education and control groups were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control Group |
| Training Group | Experimental | Other: Training Group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being between 8 and 18 years old
- Having been diagnosed with cancer and having completed treatment
- Having passed at least 30 and at most 120 days after completion of treatment.
Key exclusion criteria (7 listed)
- Having chronic lung disease,
- Having a history of hospitalization due to infection in the last month,
- Having a history of surgical intervention due to cancer,
- Having insufficient cognitive and cognitive functions,
- Having an orthopedic problem affecting mobility or a history of musculoskeletal surgical intervention,
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 |
|---|---|---|
| Training GroupAlso: Experimental GroupInspiratory muscle training (IMT) was performed using the Threshold IMT device using the threshold loading method. The IMT was administered to the patients in the training group at 30% of the MIP value, 5 days a week, twice a day, for 15 minutes for 8 weeks. The patients in the training group were called for a check-up once a week and the MIP value was re-evaluated. The training workload for that week was determined by taking 30% of the new measured MIP value. During the training, the patients were asked to sit with their upper body (shoulders and upper chest) in a relaxed position, and after the nose was closed with the clip, the mouthpiece of the device was tightly closed with the lips. While in this position, the patient was asked to inhale and exhale 5 times into the device, then remove the device from their mouth and listen for 5 breaths, and continue this cycle for 15 minutes. | Other | Training Group |
| Control GroupThe training intensity of the control group was given at the lowest load (9 cm H2O) for 8 weeks, five days a week, twice a day for 15 minutes. To eliminate the effect of learning, the MIP measure of the control group was measured once a week, but the intensity of the training was not increased during the 8 weeks. | Other | Control Group |
Primary outcome
Measurement of Pulmonary Function
Time frame: 8 weeks
A spirometry device was used to evaluate lung functions and measurements were made according to ATS/ERS criteria. Before the test, the weight (kg), height (cm), age and gender values of the patients were recorded on the spirometry device. All measurements were made in a sitting position with the feet in full contact with the ground. A nose clip was used. At the beginning of the test, inspiration and expiration were requested within the limits of tidal volume. Then, the deepest possible inspiration was followed by rapid expiration. Care was taken to ensure that the expiration period continued uninterrupted for 6 seconds. The best of three tests that were 95% compatible with each other was selected and recorded. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), Tiffeneau ratio (FEV1/FVC) and peak expiratory volume (PEF) (L/min) values were measured and both the measured values and the percentages of expected values were recorded.
Measurement of Respiratory Muscle Strength
Time frame: 8 weeks
Respiratory muscle strength was measured in accordance with ATS/ERS criteria using an electronic and portable intraoral pressure measuring device.All of the measurements were made in the sitting position with the feet in full contact with the ground. Nasal breathing was blocked with a nose clip. In order to measure the maximum inspiratory pressure (MIP), maximum expiratory maneuver was performed before the patient took the mouthpiece of the device into his mouth, and then maximal inspiration (Müller maneuver) was performed at maximum speed for 1-3 seconds. For maximum expiratory pressure measurement, the maximum inspiratory maneuver was performed before the mouthpiece of the device was taken into the mouth, and then maximal expiration (Valsalva maneuver) was performed at maximum speed for 1-3 seconds. 3 measurements were repeated for each evaluation and the highest value was recorded in "cmH2O".
Measurement of Functional Capacity
Time frame: 8 weeks
Functional capacity was measured with the 6-Minute Walk Test (6MWT) according to the guideline of ERS. The 6MWT to be a reliable, reproducible, and valid functional test for assessing exercise tolerance and endurance. Subjects were instructed to walk from one end to the other of a 30 m hallway at their own pace, while attempting to cover as much ground as possible in the allotted 6 min. The test was self-paced and the subject could rest if he or she so wished.
Measurement of Quality of Life
Time frame: 8 weeks
To determine the patients' quality of life, the Pediatric Quality of Life Scale (PedsQL 4.0), developed by Varni et al. and adapted into Turkish for the 8-12 age group by Sönmez and Başbakkal and its validity and reliability study was performed. The validity and reliability study of the 13-18 age group form of the scale was performed by Mermik et al. The total score that can be obtained from the 5-option Likert-type scale varies between 0 and 100, and scores closer to 0 indicate negative (bad) quality of life, while scores closer to 100 indicate positive (good) quality of life.
Measurement of Fatigue
Time frame: 8 weeks
The Brief Fatigue Inventory (BFI), developed by Mendoza et al. for cancer patients and whose Turkish validity and reliability study was conducted by Çinar et al., was used to determine the fatigue levels of the participants. The inventory evaluates the fatigue level of the patients in the last 24 hours and its effect on daily life activities (general activity, mood, walking ability, work life, relationships with other people, joy of life). The inventory consists of a total of 9 items, 3 of which measure general fatigue and 6 of which evaluate the effect of fatigue on daily life. The evaluation of the items is made by summing the scores between "0" (no fatigue at all) and "10" (the most severe fatigue you can experience), with "0" being the lowest score and "90" being the highest score. A low score indicates a low fatigue level and a high score indicates a high fatigue level. In this study, the evaluation was made based on the total score obtained from the scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Knowledge, Attitudes, Practice
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.
Semiramis Özyılmaz, Assoc. Prof. study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Group in people with Pediatric Cancer and Inspiratory Muscle Training, run by Medipol University 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 19 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Pulmonary Function (time frame: 8 weeks). The study lists 5 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 19 Sep 2024.