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

January 4, 2026 updated by: Susanna Hilda Hutajulu, Gadjah Mada University

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

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 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

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

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity intervention
Behavioral: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and post-intervention (12 weeks)
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).
Baseline and post-intervention (12 weeks)
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.
Baseline and post-intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory biomarkers
Time Frame: Baseline and post-intervention (12 weeks)
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).
Baseline and post-intervention (12 weeks)
Intervention acceptability
Time Frame: Post-intervention (12 weeks)
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.
Post-intervention (12 weeks)
Intervention barriers and facilitators
Time Frame: Post-intervention (12 weeks)
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.
Post-intervention (12 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention feasibility
Time Frame: During study period (baseline to 12 weeks)
Intervention feasibility was determined by (a) recruitment (ratio of the number of participants recruited to the number of eligible participants approached), (b) retention (ratio of the number of participants who completed the 12-week program to the total number of participants enrolled in the study), (c) adherence (the ratio of the number of participants meeting at least 70% of prescribed activities calculated using steps per day, resistance exercise frequency, duration, and intensity to the total number of participants completing the 12-week program). The intervention was defined as feasible if those rates were above 75%.
During study period (baseline to 12 weeks)
Adverse events
Time Frame: During study period (baseline to 12 weeks)
Adverse events (e.g., dyspnea, tachycardia, nausea, pain, and myalgia) that were reported by participants.
During study period (baseline to 12 weeks)

Collaborators and Investigators

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

Sponsor

Gadjah Mada University

Collaborators

University of Leeds
Durham University

Investigators

  • Principal Investigator: Susanna H Hutajulu, MD, PhD, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General Hospital
  • Study Chair: Shaunna Burke, PhD, Faculty of Biological Sciences, School of Biomedical Sciences, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 3, 2022

Primary Completion (Actual)

October 13, 2022

Study Completion (Actual)

February 5, 2024

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3550/UN1.P.III/DitLit/PT.01.05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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