The Effect of Inspiratory Muscle Training on Pediatric Cancer Patient

NCT ID: NCT06597552

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-10
• Study Completion Date: 2023-08-18

Brief 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. 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.

Conditions

Pediatric Cancer; Inspiratory Muscle Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

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.

Training Group

Group Type: EXPERIMENTAL

Training Group

Intervention Type: OTHER

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.

Interventions

Training 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.

Intervention Type: OTHER

Control Group

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.

Intervention Type: OTHER

Other Intervention Names

Experimental Group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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,

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: collaborator

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Onur Köksal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semiramis Özyılmaz, Assoc. Prof.

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Locations

Bezmialem Vakıf University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019/001O

Identifier Type: -

Identifier Source: org_study_id