Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Leeds | OTHER |
| Durham University | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
To answer those questions, participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and post-intervention (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention feasibility | 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%. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sardjito General Hospital | Sleman | Yogyakarta Special Region | 55284 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36466557 | Background | 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. | |
| 33921141 | Background | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | Post-intervention (12 weeks) |
| During study period (baseline to 12 weeks) |
| Adverse events | Adverse events (e.g., dyspnea, tachycardia, nausea, pain, and myalgia) that were reported by participants. | During study period (baseline to 12 weeks) |
| 29458936 | Background | 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. |
| 29376559 | Background | 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. |
| 16818906 | Background | 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. |
| 41904552 | Derived | 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided