Study design. The Home-PAC trial is a two-arm pilot randomised controlled trial comprising a 12-week structured and supervised home-based exercise intervention, comprising one weekly group exercise online session, compared to a usual care control group.
This study was conducted in collaboration with Universitario Hospital Center from Algarve (CHUA). It is a subsidiary trial of the PAC-WOMAN (NCT05860621), as it applies and tests its exercise booklet tool, developed to support and guide participants in their unsupervised physical activities at home or other unsupervised contexts.
Ethics approval
was obtained before study implementation from the Ethics Committee of Sports and Physical Education Faculty and from the Investigation Support Unit from CHUA (ref. 216.22). The trial was conducted under the declaration of Helsinki for human studies from the World Medical Association[19].
Participants. Twenty-one women were recruited from a convenience sample from CHUA.
Inclusion criteria: 1) women between stage I-III breast cancer diagnosis stage, aged between 18–75 years old; 2) currently receiving hormonal therapy after completing primary treatments; 3) reporting low to moderate levels of PA on the International Physical Activity Questionnaire (IPAQ); 4) having access to a computer with internet; 5) providing written informed consent; 6) available for online sessions or phone call.
Exclusion criteria: 1) women with medical contraindications to exercise; 2) having physical or psychiatric illnesses or conditions that enabled them to perform the assessments and/or the intervention (e.g. pregnancy or non-controlled heart, metabolic or respiratory diseases); 3) evidence of stage IV cancer, new or recurrent tumours; ) already in an exercise program.
Procedures
Participant selection. Medical professionals selected potential participants and provided a contact list. One researcher (PGFR) contacted potential participants via phone or text message to gauge their interest in the project and invited them for an informational meeting where project details were explained, doubts cleared, and interested participants signed the written informed consent.
Randomisation. After baseline assessments, participants were randomly assigned to either intervention group or usual care control group using GraphPad (https://www.graphpad.com/quickcalcs/randomize1/).
Intervention
Home-based exercise intervention group. Women in this group received an exercise booklet, including different exercises to be performed at home, accompanied by QR codes with instructive videos, how to structure the training sessions, PA guidelines, safety measures, alert signs to attend before and while exercising, and required equipment. Instructions and demonstrations of the booklet exercises and how to use the perceived exercise effort tool (Borg's scale) and assemble their sessions were provided through an online session.
A weekly 50-minute online exercise group session using Zoom software was delivered to provide exercise execution corrections and advice on achieving proper volume and intensity in unsupervised training sessions. Each session included a 10-minute warm-up with mobility and activation exercises, a 30-minute component with aerobic and resistance exercises, and a 10-minute cooldown with breathing and stretching exercises [20]. Participants were encouraged to perform 2 additional unsupervised training sessions per week using the exercise booklet and perform brisk walks at a moderate to vigorous intensity.
Exercise logs. Exercise logs were emailed to all participants to register and self-monitor the frequency, volume, perceived intensity and type of activities performed on unsupervised training and control any exercise-related adverse events. Participants were asked to send their weekly logs for tailored feedback from the exercise professional.
Control group. This group was asked to maintain usual care and current daily routines. After the intervention, participants were offered the exercise booklet and the Home-PAC intervention. During the intervention period, participants received six phone calls or a text message every 2 weeks to maintain their interest in the study. No discussion, encouragement or counselling on PA was provided[21]. A log was filled including the length of the calls, participants' health status, dropout reasons (if applicable), and other relevant information.
Assessments
All assessments were performed at baseline and end-of-intervention (12 weeks), in standardised conditions, at a local sports centre.
Demographics. Age, education level, PA history, and treatment details (breast cancer stage, dates and types of primary treatments, starting date, and type of hormonal therapy received) were collected from participants’ medical records and a general information questionnaire.
Functional performance (primary outcome). Functional performance was assessed by measuring strength (30-s chair stand and arm curl), agility (8-Foot Up and Go), aerobic capacity (6-minute walk), and flexibility (chair sit-and-reach and back scratch) [22]–[24].
Quality of life (secondary outcome). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and breast cancer module (EORTC QLQ-BR23) were used to assess the cancer-related quality of life[25], [26]. EORT QLQ C-30 is a 30-item questionnaire comprising 8 multi-item functional and symptom subscales, one global health status and quality of life subscale, and 6 single items. Scores range from 0 to 100 for all scales. High scores in global health and functional scales reflect a higher quality of life and functioning, whereas high scores in symptoms reflect elevated levels of problems[25], [27]. The breast cancer module QLQ-BR23 includes 23 questions grouped into 6 functional and symptom subscales. High scores on functional scales show better functioning, and high scores on the symptoms scale and body image represent higher issues[25], [27].
PA (secondary outcome). The IPAQ-SF[28] was used to assess PA levels. The IPAQ-SF is a 9-item questionnaire that measures the weekly time spent on various intensities of physical activity (i.e., light, moderate, and vigorous) and sitting time during the week and weekend days. Total PA scores and discrimination by intensity were derived from the data collected (min/week)[28], [29].
Adherence and adverse events (other outcomes). Adherence was assessed through inspection of exercise logs, which included the duration, frequency, type of activity, rate of perceived exertion, using the Borg CR-10 scale, and self-reported adverse effects felt during exercise[30]–[32]. Adherence to the supervised sessions was assessed through presence calculations and a registry.
Statistical procedures
All statistical analyses were performed using SPSS Statistics (version 26). The significance level of the statistical test was determined at 5%. Descriptive statistics were used to characterise sample features, levels of adherence to the intervention and reported adverse events. Independent Sample T-tests were used to compare both groups at baseline. Factorial Ancovas with repeated measures, adjusting for potential covariates (e.g., primary treatment, length of therapy), were conducted to explore time by group interaction and between and within changes in the study's primary and secondary outcomes (functional performance, quality of life and PA). Kolmogorov-Simonov tests were conducted to test the normality of the outcome variables, and in cases where normality was not satisfied, non-parametric tests (e.g. Kruskal-Wallis) were performed.