Feasibility and Effects of Home-based Physical Activity Intervention in Patients With Breast Cancer in Indonesia
NCT ID: NCT07338903
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2022-01-03
2024-02-05
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Physical activity intervention
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Evidence of cardiac disease, severe musculoskeletal problems, or other contraindications for exercise.
17 Years
70 Years
FEMALE
No
Sponsors
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University of Leeds
OTHER
Durham University
OTHER
Gadjah Mada University
OTHER
Responsible Party
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Susanna Hilda Hutajulu
Susanna Hilda Hutajulu, MD, PhD
Principal Investigators
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Susanna H Hutajulu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General Hospital
Shaunna Burke, PhD
Role: STUDY_CHAIR
Faculty of Biological Sciences, School of Biomedical Sciences, University of Leeds
Locations
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Dr. Sardjito General Hospital
Sleman, Yogyakarta Special Region, Indonesia
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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3550/UN1.P.III/DitLit/PT.01.05
Identifier Type: -
Identifier Source: org_study_id
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