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

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.

Conditions

• Breast Neoplasms
• Physical Fitness

Interventions

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.

Sponsors & Collaborators

• University of Leeds

  collaborator OTHER

• Durham University

  collaborator OTHER

• Gadjah Mada University

  lead OTHER

Principal Investigators

• Susanna H Hutajulu, MD, PhD · Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General Hospital

• Shaunna Burke, PhD · Faculty of Biological Sciences, School of Biomedical Sciences, University of Leeds

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

17 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-03

Primary Completion

2022-10-13

Completion

2024-02-05

Countries

• Indonesia

Study Locations