Breast CancerNCT06537336
Optimizing Pulmonary Health and Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial Combining Incentive Spirometry and Aerobic Exercise
A study testing QoL and lung function in people with Breast Cancer, run by Hermina Hospitals at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- QoL and lung function
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2023to 1 Jun 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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- neuromuscular dysfunction (spinal muscular atrophy, Guillain-Barré syndrome, and multiple sclerosis);
- degenerative arthritis;
- physical limitations affecting stationary cycling; and
- musculoskeletal disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- QoL, lung function
- Keywords
- Aerobic exercise, Breast cancer, Incentive spirometry, Lung function, Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QoLDevice
QoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30).
lung functionDevice
lung function tests using spirometry
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The patients in the treatment group underwent aerobic and volumetric incentive spirometry breathing exercises Receives: Device: QoL; Device: lung function |
| control group | Active comparator | The control group performed only aerobic exercise. Receives: Device: QoL; Device: lung function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8 weeks of exercises
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Apr 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hermina Hospitals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran
- Responsible party
- Principal investigator, Geraldi Christian Candra, Hermina Hospitals
- Investigators
- Dian M Sari, dr, Study chair, Padjajaran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537336
- Sponsor's protocol ID
- LB.02.01/X.6.5/76/2023
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pulmonary Health and Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial Combining Incentive Spirometry and Aerobic Exercise
- ClinicalTrials.gov ID
- NCT06537336
- Acronym / sponsor ID
- LB.02.01/X.6.5/76/2023
- Conditions
- Breast Cancer
- Keywords
- Aerobic exercise, Breast cancer, Incentive spirometry, Lung function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hermina HospitalsIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 5 Aug 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: QoL, Device: lung functionThe patients in the treatment group underwent aerobic and volumetric incentive spirometry breathing exercises |
| control group | Active comparator | Device: QoL, Device: lung functionThe control group performed only aerobic exercise. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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);
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 |
|---|---|---|
| QoLQoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30). | Device | control group, treatment group |
| lung functionlung function tests using spirometry | Device | control group, treatment group |
Primary outcome
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
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
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 9 Aug 2024.
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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.
Dian M Sari, dr study chair
Padjajaran 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 QoL and lung function in people with Breast Cancer, run by Hermina Hospitals at 1 site in Indonesia.
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 6 inclusion and 10 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 9 Aug 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 Indonesia. 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?
lung function (time frame: 8 weeks of exercises). The study lists 2 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 9 Aug 2024.