Breast NeoplasmsNCT07338903

Feasibility and Effects of Home-based Physical Activity Intervention in Patients With Breast Cancer in Indonesia

A study testing 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands in people with Breast Neoplasms and Physical Fitness, run by Gadjah Mada University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to learn the impact and implementation of home-based aerobic and resistance training for patients with breast cancer in Indonesia. The main questions it aims to answer are: Does the home-based aerobic and resistance training improve physical fitness, fatigue, and quality of life of… Read more about this study

Who is it for?: Ages 17 to 70 years, women only
Conditions the study is for: Breast Neoplasms, Physical Fitness
What is being tested?: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteIndonesia
Study dates: 3 Jan 2022to 5 Feb 2024
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 17 to 70 years
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients with stage I-III hormone-receptor positive breast cancer
Eastern Cooperative Oncology Group (ECOG) score ≤1
Had completed primary treatment (e.g., surgery, chemotherapy, and radiotherapy), except for hormonal treatment
Within 5 years of diagnosis
Able to perform moderate-intensity physical activity as determined by their oncologist and care team
Able to read and write in Indonesian
Willing to provide written informed consent.

Who cannot join

Had an ejection fraction of <50%
Evidence of cardiac disease, severe musculoskeletal problems, or other contraindications for exercise.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Dr. Sardjito General Hospital
Sleman, Yogyakarta Special Region, 55284

Other trials in Indonesia

About this study

Official title: Move to Improve: Investigating the Feasibility of Embedding Physical Activity Into Routine Breast Cancer Care in Indonesia

Does the home-based aerobic and resistance training improve physical fitness, fatigue, and quality of life of patients with breast cancer?
Are the benefits of aerobic and resistance training mediated by inflammatory level changes?
What are the barriers and facilitators in implementing the home-based aerobic and resistance training?
Is the home-based aerobic and resistance training feasible to be implemented in Indonesia's setting?

To answer those questions, participants will:

Conduct home-based aerobic and resistance training with supervision.
Visit the hospital once every 4 weeks for their routine visits.
Undergo physical fitness test before and after 12 weeks using treadmill test, as well as interviews to assess fatigue, quality of life, and intervention acceptability.
Keep a diary to record the aerobic and resistance training at home.
Undergo routine monitoring by phone every week with the research team.

Conditions: Breast Neoplasms, Physical Fitness
Being tested: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands
Keywords: Breast neoplasms, Physical activity, Exercise, Walking, Resistance exercise, Physical fitness, Fatigue, Quality of life
Medical subject headings: Breast Neoplasms, Motor Activity, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bandsBehavioural
1. Home-based aerobic training: The aerobic exercise consisted of a walking program based on the number of steps per day, which was recorded using a pedometer (Yamax Digiwalker SW-200, Tokyo, Japan). The target of the aerobic exercise was individually tailored by adding 3000 accumulated steps above their baseline value on 5 days of the week.
2. Home-based resistance training: The resistance training was conducted using a set of resistance bands (Happy Fit®, Jakarta, Indonesia). This training consisted of two sets of biceps curl, triceps extension, chest press, shoulder flexion, shoulder press, lateral extension, seated row, and upright row, with 8-10 repetitions. Patients were instructed to perform each exercise with an average total duration of 10 minutes on 2 days a week at home. The exercises were individually tailored based on participants' strength and range of movement using a set of three color-coded bands representing low, moderate, and high levels of resistance.

Study groups in NCT07338903
Study group	Role	What they receive
Physical activity intervention	Experimental	Not described Receives: Behavioral: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical fitness
Physical fitness was measured using a submaximal treadmill test with the modified Bruce protocol. Treadmill speed and inclination were automatically increased every 3 min (test stage). The test was terminated when participants reached volitional fatigue. Physical fitness was classified as low, fair, average, and good, based on patients' age, treadmill test duration, and predicted VO2peak.
Measured: Baseline and post-intervention (12 weeks)
Fatigue
Fatigue was assessed using the Indonesian version of Fatigue Severity Scale (FSS). A higher score on the FSS indicated a more severe level of fatigue. The FSS was also classified as no-to-mild fatigue (FSS <4.0) and severe fatigue (≥4.0).
Measured: Baseline and post-intervention (12 weeks)
Health-related quality of life
Health-related quality of life was assessed using the Indonesian version of the EORTC Quality of Life Questionnaire (QLQ-C30). The EORTC QLQ-C30 consists of global health status, functional scales, and symptom scales. A higher score indicates better health for global health status and functional scales, but represents a higher level of burden for symptom scales.
Measured: Baseline and post-intervention (12 weeks)

Secondary outcomes (3)

Inflammatory biomarkers
Venous blood (5 ml) was collected at baseline and post-intervention to measure the levels of inflammatory biomarkers, including CRP, IL-6, and IL-10. The CRP levels were measured using an Enzyme-Linked Immunosorbent Assay (ELISA) assay (Calbiotech, CR120C), while IL-6 and IL-10 were measured using a Luminex assay (eBioscience, PPX-02-MXYMMK2).
Measured: Baseline and post-intervention (12 weeks)
Intervention acceptability
Intervention acceptability was explored using semi-structured interviews using a research team-developed interview guide. All interviews were individual and face-to-face, took place in a private room, and were audiotaped.
Measured: Post-intervention (12 weeks)
Intervention barriers and facilitators
Intervention barriers and facilitators were explored using semi-structured interviews using research team-developed interview guide. All interviews were individual and face-to-face, took place in a private room, and audiotaped.
Measured: Post-intervention (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 20225 Feb 2024

First posted14 Jan 2026
Study start3 Jan 2022
Primary completion13 Oct 2022
Study completion5 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Breast NeoplasmsStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07338903
Sponsor's protocol ID: 3550/UN1.P.III/DitLit/PT.01.05
Status last verified: Jan 2026
First submitted: 4 Jan 2026
Last updated: 14 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The IPD that underlie results in the publication are accessible from the corresponding author upon reasonable request and subject to applicable data sharing agreements and approval processes.

Publications

Leite VF, Cecatto RB, Battistella LR, de Brito CMM. Establishing a Cancer Rehabilitation Service in a Middle-Income Country: an Experience from Brazil. Curr Phys Med Rehabil Rep. 2022;10(4):339-344. doi: 10.1007/s40141-022-00373-4. Epub 2022 Nov 28.
PubMed 36466557
Batalik L, Winnige P, Dosbaba F, Vlazna D, Janikova A. Home-Based Aerobic and Resistance Exercise Interventions in Cancer Patients and Survivors: A Systematic Review. Cancers (Basel). 2021 Apr 15;13(8):1915. doi: 10.3390/cancers13081915.
PubMed 33921141
de Jesus Leite MAF, Puga GM, Arantes FJ, Oliveira CJF, Cunha LM, Bortolini MJS, Penha-Silva N. Effects of combined and resistance training on the inflammatory profile in breast cancer survivors: A systematic review. Complement Ther Med. 2018 Feb;36:73-81. doi: 10.1016/j.ctim.2017.11.023. Epub 2017 Dec 1.
PubMed 29458936
Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity for women with breast cancer after adjuvant therapy. Cochrane Database Syst Rev. 2018 Jan 29;1(1):CD011292. doi: 10.1002/14651858.CD011292.pub2.
PubMed 29376559
McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
PubMed 16818906
Astari YK, Hutajulu SH, Fitriani Z, Mozhaf MDLQ, Paramita DK, Wibowo RA, Sofia NA, Hartopo AB, Hardianti MS, Purwanto I, Burke S. The changes of inflammatory biomarkers after a 12-week home-based aerobic and resistance exercise intervention in breast cancer survivors. BMC Res Notes. 2026 Mar 28;19(1):208. doi: 10.1186/s13104-026-07764-z.
PubMed 41904552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Move to Improve: Investigating the Feasibility of Embedding Physical Activity Into Routine Breast Cancer Care in Indonesia
ClinicalTrials.gov ID: NCT07338903
Acronym / sponsor ID: 3550/UN1.P.III/DitLit/PT.01.05
Conditions: Breast Neoplasms, Physical Fitness
Keywords: Breast neoplasms, Physical activity, Exercise, Walking, Resistance exercise, Physical fitness, Fatigue, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Gadjah Mada UniversityUniversity, hospital or other
Collaborators: University of Leeds, Durham University
Study start: 3 Jan 2022 (actual)
Primary completion: 13 Oct 2022 (actual)
Study completion: 5 Feb 2024 (actual)
First posted: 14 Jan 2026 (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.

Does the home-based aerobic and resistance training improve physical fitness, fatigue, and quality of life of patients with breast cancer?
Are the benefits of aerobic and resistance training mediated by inflammatory level changes?
What are the barriers and facilitators in implementing the home-based aerobic and resistance training?
Is the home-based aerobic and resistance training feasible to be implemented in Indonesia's setting?

To answer those questions, participants will:

Conduct home-based aerobic and resistance training with supervision.
Visit the hospital once every 4 weeks for their routine visits.
Undergo physical fitness test before and after 12 weeks using treadmill test, as well as interviews to assess fatigue, quality of life, and intervention acceptability.
Keep a diary to record the aerobic and resistance training at home.
Undergo routine monitoring by phone every week with the research team.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Physical activity intervention	Experimental	Behavioral: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands

Who may qualify

Ages: 17 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Patients with stage I-III hormone-receptor positive breast cancer
Eastern Cooperative Oncology Group (ECOG) score ≤1
Had completed primary treatment (e.g., surgery, chemotherapy, and radiotherapy), except for hormonal treatment
Within 5 years of diagnosis
Able to perform moderate-intensity physical activity as determined by their oncologist and care team

Key exclusion criteria (2 listed)

Had an ejection fraction of <50%
Evidence of cardiac disease, severe musculoskeletal problems, or other contraindications for exercise.

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
12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands1. Home-based aerobic training: The aerobic exercise consisted of a walking program based on the number of steps per day, which was recorded using a pedometer (Yamax Digiwalker SW-200, Tokyo, Japan). The target of the aerobic exercise was individually tailored by adding 3000 accumulated steps above their baseline value on 5 days of the week. 2. Home-based resistance training: The resistance training was conducted using a set of resistance bands (Happy Fit®, Jakarta, Indonesia). This training consisted of two sets of biceps curl, triceps extension, chest press, shoulder flexion, shoulder press, lateral extension, seated row, and upright row, with 8-10 repetitions. Patients were instructed to perform each exercise with an average total duration of 10 minutes on 2 days a week at home. The exercises were individually tailored based on participants' strength and range of movement using a set of three color-coded bands representing low, moderate, and high levels of resistance.	Behavioural	Physical activity intervention

Primary outcome

Physical fitness
Time frame: Baseline and post-intervention (12 weeks)
Physical fitness was measured using a submaximal treadmill test with the modified Bruce protocol. Treadmill speed and inclination were automatically increased every 3 min (test stage). The test was terminated when participants reached volitional fatigue. Physical fitness was classified as low, fair, average, and good, based on patients' age, treadmill test duration, and predicted VO2peak.
Fatigue
Time frame: Baseline and post-intervention (12 weeks)
Fatigue was assessed using the Indonesian version of Fatigue Severity Scale (FSS). A higher score on the FSS indicated a more severe level of fatigue. The FSS was also classified as no-to-mild fatigue (FSS <4.0) and severe fatigue (≥4.0).
Health-related quality of life
Time frame: Baseline and post-intervention (12 weeks)
Health-related quality of life was assessed using the Indonesian version of the EORTC Quality of Life Questionnaire (QLQ-C30). The EORTC QLQ-C30 consists of global health status, functional scales, and symptom scales. A higher score indicates better health for global health status and functional scales, but represents a higher level of burden for symptom scales.

3 secondary outcomes

Inflammatory biomarkers
Time frame: Baseline and post-intervention (12 weeks)
Intervention acceptability
Time frame: Post-intervention (12 weeks)
Intervention barriers and facilitators
Time frame: Post-intervention (12 weeks)

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 14 Jan 2026.
Background: PubMed 36466557Leite VF, Cecatto RB, Battistella LR, de Brito CMM. Establishing a Cancer Rehabilitation Service in a Middle-Income Country: an Experience from Brazil. Curr Phys Med Rehabil Rep. 2022;10(4):339-344. doi: 10.1007/s40141-022-00373-4. Epub 2022 Nov 28.
Background: PubMed 33921141Batalik L, Winnige P, Dosbaba F, Vlazna D, Janikova A. Home-Based Aerobic and Resistance Exercise Interventions in Cancer Patients and Survivors: A Systematic Review. Cancers (Basel). 2021 Apr 15;13(8):1915. doi: 10.3390/cancers13081915.
Background: PubMed 29458936de Jesus Leite MAF, Puga GM, Arantes FJ, Oliveira CJF, Cunha LM, Bortolini MJS, Penha-Silva N. Effects of combined and resistance training on the inflammatory profile in breast cancer survivors: A systematic review. Complement Ther Med. 2018 Feb;36:73-81. doi: 10.1016/j.ctim.2017.11.023. Epub 2017 Dec 1.
Background: PubMed 29376559Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity for women with breast cancer after adjuvant therapy. Cochrane Database Syst Rev. 2018 Jan 29;1(1):CD011292. doi: 10.1002/14651858.CD011292.pub2.
Background: PubMed 16818906McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
Derived from this study: PubMed 41904552Astari YK, Hutajulu SH, Fitriani Z, Mozhaf MDLQ, Paramita DK, Wibowo RA, Sofia NA, Hartopo AB, Hardianti MS, Purwanto I, Burke S. The changes of inflammatory biomarkers after a 12-week home-based aerobic and resistance exercise intervention in breast cancer survivors. BMC Res Notes. 2026 Mar 28;19(1):208. doi: 10.1186/s13104-026-07764-z.
Individual participant dataSharing planned: Yes. The IPD that underlie results in the publication are accessible from the corresponding author upon reasonable request and subject to applicable data sharing agreements and approval processes.

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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.

Susanna H Hutajulu, MD, PhD principal investigator

Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General Hospital

Shaunna Burke, PhD study chair

Faculty of Biological Sciences, School of Biomedical Sciences, University of Leeds

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 2 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 14 Jan 2026. 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?

Physical fitness (time frame: Baseline and post-intervention (12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07338903, which also lists 6 linked publications.

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 14 Jan 2026.