Status:
COMPLETED
Optimizing Pulmonary Health and Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial Combining Incentive Spirometry and Aerobic Exercise
Lead Sponsor:
Hermina Hospitals
Collaborating Sponsors:
Universitas Padjadjaran
Conditions:
Breast Cancer
Eligibility:
All Genders
30-59 years
Phase:
NA
Brief Summary
Breast cancer survivors frequently experience diminished lung function and decreased quality of life (QoL) following radiation therapy (RT). Additionally, incentive spirometry, which encourages prolon...
Detailed Description
Study Design This experimental study employed a single-blind randomized controlled trial design with two groups. Consecutive sampling was conducted based on the order of arrival. Group allocation (con...
Eligibility Criteria
Inclusion
- age between 30 and 59 years;
- diagnosis of histological breast cancer (AJCC Stage I to III) and completion of RT for \> 3 months;
- hemoglobin level \> 10 mg/dL;
- ability to comprehend verbal and written instructions;
- cooperative participants, willingness to participate in the study, and ability to engage in exercises by signing an informed consent form; and
- Nonreactive COVID-19 antigen swab test results.
Exclusion
- cancer metastasis to the bone, lungs, or surrounding organs;
- aerobic exercise and incentive spirometry breathing exercises within the last six months;
- uncontrolled hypertension (blood pressure \>140/90 mmHg on antihypertensive treatment);
- unstable cardiovascular diseases (including unstable angina, acute myocardial infarction, arrhythmias, severe valvular heart disease, severe arteriovenous stenosis, and decompensated congestive heart failure) determined from medical records, history, physical examination, and electrocardiograms;
- uncontrolled blood sugar level (random blood sugar \>200 mg/dL or fasting blood sugar \>126 mg/dL);
- acute or chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, and pulmonary tuberculosis);
- neuromuscular dysfunction (spinal muscular atrophy, Guillain-Barré syndrome, and multiple sclerosis);
- degenerative arthritis;
- physical limitations affecting stationary cycling; and
- musculoskeletal disorders.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06537336
Start Date
April 1 2023
End Date
June 1 2023
Last Update
August 9 2024
Active Locations (1)
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1
Padjajaran University
Bandung, West Java, Indonesia, 40161