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

August 6, 2024 updated by: Geraldi Christian Candra, Hermina Hospitals
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 (control group with aerobic exercise or treatment group with incentive spirometry breathing exercises combined with aerobic exercise) was determined using a simple random sampling method with a lottery. The data were analyzed using SPSS version 25.0.

Participants Participants were patients with breast cancer who had completed Radiotherapy at Hasan Sadikin General Hospital Bandung between April 2023 and June 2023.

Research Procedure 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). The EORTC-QLQ-C30 was designed to assess seven domains of QoL in cancer patients: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, overall health status, and symptom domains. The EORTC-QLQ-C30 questionnaire has been translated into Indonesian from Dyah A.P's research. and has shown validity scores >0.70 and reliability scores >0.80 in evaluating the QoL of cancer patients undergoing therapy.14 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. The training frequency was three times per week. Each session lasted 40 min, consisting of 5 min of warm-up, 30 min of main exercise, and 5 min of cool-down. The exercise intensity was moderate (RPE 12-13).

Volumetric incentive spirometry exercises were performed 15 min after completing the aerobic exercise. This exercise used sustained maximal incentive spirometry (Voldyne 5000®). The program was conducted over eight weeks with a training frequency of three times per week. Each session included five sets of exercises, with each set consisting of 10 breathing repetitions and a 1-minute rest between sets. The intensity of this exercise involved performing maximal inspiration from the residual volume (RV) to the total lung capacity (TLC) that the subject could achieve. The inspiratory volume reached was used as the target for subsequent training sessions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Padjajaran University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: treatment group
The patients in the treatment group underwent aerobic and volumetric incentive spirometry breathing exercises
Device: QoL
QoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30).
Device: lung function
lung function tests using spirometry
Active Comparator: control group
The control group performed only aerobic exercise.
Device: QoL
QoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30).
Device: lung function
lung function tests using spirometry

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
lung function
Time Frame: 8 weeks of exercises
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).
Time Frame: 8 weeks of exercises
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hermina Hospitals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitas Padjadjaran

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dian M Sari, dr, Padjajaran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LB.02.01/X.6.5/76/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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