NCT07338903

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 4, 2026

Last Update Submit

January 4, 2026

Conditions

Breast NeoplasmsPhysical Fitness

Keywords

Breast neoplasmsPhysical activityExerciseWalkingResistance exercisePhysical fitnessFatigueQuality of life

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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.

    Baseline and post-intervention (12 weeks)

Secondary Outcomes (3)

  • Inflammatory biomarkers

    Baseline and post-intervention (12 weeks)

  • Intervention acceptability

    Post-intervention (12 weeks)

  • Intervention barriers and facilitators

    Post-intervention (12 weeks)

Other Outcomes (2)

  • Intervention feasibility

    During study period (baseline to 12 weeks)

  • Adverse events

    During study period (baseline to 12 weeks)

Study Arms (1)

Physical activity intervention

EXPERIMENTAL
Behavioral: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands

Interventions

12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bandsBEHAVIORAL

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.

Physical activity intervention

Eligibility Criteria

Age17 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sardjito General Hospital

Sleman, Yogyakarta Special Region, 55284, Indonesia

Location

Related Publications (6)

  • 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.

    PMID: 36466557BACKGROUND

  • 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.

    PMID: 33921141BACKGROUND

  • 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.

    PMID: 29458936BACKGROUND

  • 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.

    PMID: 29376559BACKGROUND

  • 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.

    PMID: 16818906BACKGROUND

  • 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. doi: 10.1186/s13104-026-07764-z. Online ahead of print. No abstract available.

    PMID: 41904552DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor ActivityFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susanna H Hutajulu, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Shaunna Burke, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Susanna Hilda Hutajulu, MD, PhD

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 14, 2026

Study Start

January 3, 2022

Primary Completion

October 13, 2022

Study Completion

February 5, 2024

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP

Locations

ID(1)