Optimizing Pulmonary Health and Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial Combining Incentive Spirometry and Aerobic Exercise

NCT06537336 | Completed

• 1 other identifier: LB.02.01/X.6.5/76/2023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 prolonged deep breathing, could potentially amplify lung function and QoL when paired with aerobic exercises. This study investigated the combined effect of aerobic and breathing exercises using incentive spirometry on lung function and QoL in patients with breast cancer after RT.

Conditions

Breast Cancer

Keywords

Aerobic exercise; Breast cancer; Incentive spirometry; Lung function; Quality of life

Outcome Measures

Primary Outcomes (2)

• lung function

  Lung function tests will be assessed using a spirometry. It measures the value of predicted forced vital capacity (FVC) and forced expiratory volume in one second/forced vital capacity (FEV1/FVC ratio). lower scores are associated with poor lung function

  8 weeks of exercises

• quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30).

  The EORTC-QLQ-C30 was designed to assess seven domains of quality of life in cancer patients: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, overall health status, and symptom domains. scores range from 0 to 100, with higher scores indicating better quality of life

  8 weeks of exercises

Study Arms (2)

treatment group

EXPERIMENTAL

The patients in the treatment group underwent aerobic and volumetric incentive spirometry breathing exercises

Device: QoL; Device: lung function

control group

ACTIVE COMPARATOR

The control group performed only aerobic exercise.

Device: QoL; Device: lung function

Interventions

QoL DEVICE

QoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30).

control group; treatment group

lung function DEVICE

lung function tests using spirometry

control group; treatment group

Eligibility Criteria

• Age: 30 Years - 59 Years
• Gender Eligibility Details: age between 30 and 59 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hermina Hospitals: lead
• Universitas Padjadjaran: collaborator

Study Sites (1)

Padjajaran University

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dian M Sari, dr

  Padjajaran University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patients in the treatment group underwent aerobic and volumetric incentive spirometry breathing exercises. The control group performed only aerobic exercise. The aerobic exercise program was conducted over 8 weeks using a stationary bicycle. Patients were initially selected based on the inclusion and exclusion criteria, and informed consent was obtained. Before and after the intervention, lung function tests using spirometry and QoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30).

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 5, 2024
• Study Start: April 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

ID (1)