An interventional study of Behavioral Rowing-based exercise therapy program in Breast Cancer, sponsored by Università Cattolica di Milano. Completed at 2 sites in Italy. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Università Cattolica di Milano · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if a six-month exercise program that combines rowing, walking, and adapted physical activity (such as yoga or Pilates) can improve health and quality of life in women aged 40 to 65 who have had surgery for breast cancer and have completed their post-surgery treatments. Regular exercise is known to benefit cancer survivors, but many women become much less active during and after treatment and do not return to their previous levels. Group water sports such as dragon boat paddling have shown promising results, while very few studies have looked at rowing. This study will also learn about the safety of the program and about how the body responds to rowing.
The main questions it aims to answer are whether the program improves physical fitness, including aerobic capacity, hand grip strength, flexibility, and body composition, and whether it improves quality of life and reduces cancer-related fatigue. The study also asks whether practicing rowing brings psychological benefits, such as higher self-esteem, greater enjoyment of physical activity, and a better sense of satisfaction in three areas of life: work, friendship, and love. In addition, it will examine what energy and oxygen demands rowing places on the body, and whether the program is safe and feasible, by recording any exercise-related adverse events and how many of the scheduled sessions participants complete.
Before joining, participants will be recruited through the hospital's Breast Unit and will need medical clearance from a physiatrist and a sports medicine physician, who will check their health and eligibility. Participants will then follow the six-month program, doing every week one hour of rowing at a rowing club, one hour of walking on their own, and one hour of adapted physical activity, yoga, or Pilates delivered online by qualified instructors. Rowing sessions will take place in stable boats designed for beginners, in small groups of no more than ten women, with certified instructors, a psychologist, and trained volunteers supervising from the water. Exercises will be adapted to each woman's starting level and will progress gradually. At the start, after three months, and at the end of the program, participants will complete fitness tests (a submaximal cycling test, hand grip strength, flexibility, and body measurements) and questionnaires on physical activity, quality of life, fatigue, self-esteem, enjoyment of exercise, and life satisfaction. After each training session they will also rate how hard it felt, and during selected rowing training sessions, a portable face-worn device will measure their breathing and oxygen use while they are rowing.
BACKGROUND AND THEORETICAL RATIONALE
The beneficial effects of adapted physical activity (APA) in cancer patients have been extensively demonstrated. Engaging in regular and sufficient levels of physical activity (PA) following a diagnosis of early-stage, potentially curable cancer is associated with a reduced risk of mortality from breast, prostate, and colorectal cancer. Emerging evidence also suggests that sedentary behavior and screen-based activities are independent risk factors for cancer mortality. Both aerobic and resistance exercise have been shown to provide physiological benefits and improvements in quality of life, including enhanced cardiovascular fitness, increased upper- and lower-limb muscle strength, and greater lean body mass. Reductions in fatigue, depression, and sleep disturbances have also been observed, and supervised exercise appears to produce greater improvements than unsupervised exercise.
Exercise volume often decreases during cancer treatment and may not return to pre-diagnosis levels after treatment completion. Only a very small proportion (8%) of individuals achieves 150 minutes per week of moderate-to-vigorous PA following diagnosis and surgery. Breast cancer survivors who have undergone surgery spend most of their day in sedentary activities (66%) or light-intensity PA (33%). Promoting exercise while avoiding unnecessary barriers to participation is therefore of fundamental importance. When appropriately structured, exercise is safe for nearly all patients, and its health benefits outweigh the risks for most individuals. A medical evaluation is necessary beforehand, particularly in the presence of comorbidities such as cardiovascular diseases. Breast cancer survivors are usually prescribed shoulder and arm mobility exercises and upper-body exercises, followed by flexibility exercises 2-3 times per week (for example yoga or Pilates), together with aerobic and resistance training. Aerobic training is recommended 3-5 times per week at 40-60% of oxygen uptake reserve or heart rate reserve, for more than 30 minutes per session (for example walking, cycling, or swimming). Resistance training is recommended 2-3 times per week at a moderate intensity (corresponding to 60-70% of 1-RM, or 6-15 repetitions per exercise), through a circuit of 8-10 exercises targeting all major muscle groups, using body weight or resistance machines.
Upper-limb lymphedema is a complication that may occur in women with breast cancer after surgery and/or radiotherapy. Several studies have reported that dragon boat paddling can be performed safely and may benefit these women. This activity is increasingly popular, partly because it is performed outdoors and has positive therapeutic effects. The paddling movement has been associated with a reduction in arm circumference without adversely affecting pre-existing lymphedema, and dragon boat training has been associated with improvements in anthropometric parameters, physical fitness, and myocardial function, contributing to better health and quality of life.
Few studies have investigated the effects of rowing. In one study, twelve weeks of rowing training (three sessions per week of 60-90 minutes) improved cardiorespiratory fitness, muscular strength, flexibility, and body composition. Because the present study involves women who have been diagnosed with breast cancer and have undergone treatments and/or surgery resulting in bodily alterations, it is important to evaluate the effectiveness of rowing not only in terms of physiological outcomes but also psychological outcomes, with attention to the impact of cancer on biopsychosocial well-being.
The theoretical framework is Individual Psychology, developed by Alfred Adler (1870-1937), who viewed individuals holistically, recognizing their uniqueness. According to Adler, individuals must address three fundamental life tasks: social life (friendship), work, and intimate relationships (love). The way they approach these tasks reflects their lifestyle and is related to their sense of community and social interest, which foster cooperation. When individuals experience feelings of organ inferiority, as may occur in women after the sudden onset of illness, they may withdraw from social, emotional, and professional life, and restoring self-esteem through encouragement becomes essential. Sports participation, and specifically rowing in this study, may be a valuable means of supporting this recovery.
OBJECTIVES
The primary aim is to investigate the effects of an exercise therapy program consisting of rowing, walking, and APA in breast cancer survivors who have undergone surgery, and to evaluate its therapeutic effectiveness on health-related parameters and quality of life after a six-month intervention. The study also aims to investigate the effects of rowing on metabolic parameters and to evaluate the psychological benefits associated with its practice. The psychological effects will be explored through self-report questionnaires, as part of a pilot study, focusing on the three life tasks of Adler's Individual Psychology: work, friendship, and love.
STUDY PROCEDURE
The project is presented at an open day at Canottieri Corgeno, where informational leaflets are distributed. Participants are then recruited through the Breast Unit and Physiotherapy Department of Ospedale di Circolo di Varese. The first contact provides a comprehensive overview of the research project. The first appointment is dedicated to obtaining medical clearance from a physiatrist. At the second appointment, a sports medicine physician assesses eligibility for the APA program and evaluates clinical and physical condition. At the third appointment (T0), baseline assessments are performed; they are repeated at three months (T1) and at six months (T2).
Participants are divided into three categories based on GPAQ results: active (physically active before and after surgery), semi-active (active before but inactive after surgery), and sedentary (inactive both before and after surgery). The aim is to provide an exercise program tailored as closely as possible to individual needs, with particular attention to the gradual introduction to rowing.
EXERCISE PROGRAM
The intervention lasts six months. Each week, participants perform one hour of rowing, one hour of walking, and one hour of online activity (APA, yoga, or Pilates). Participants are divided into two groups of a maximum of 10 women for the APA, yoga, Pilates, and rowing sessions, to allow optimal assessment, instruction, and supervision.
Adapted physical activity (APA): The online weekly session focuses on joint mobility, postural control, and functional strengthening, with progressively increasing resistance and movement complexity based on participants' weekly feedback and perceived physical condition. Each circuit consists of 4-5 exercises with 8-10 repetitions per exercise for the upper and lower limbs, while plank and crunch exercises are performed for 30 seconds. Rest lasts 40 seconds between successive rounds and two minutes between circuits. The first part of each session focuses on joint mobility and muscle activation. The second part includes functional exercises using resistance bands, bodyweight, or light external weights (0.5 kg and 1 kg): upper-body strengthening (presses, internal and external shoulder rotations), abdominal and core strengthening (planks, crunches), and lower-body strengthening (static or semi-static lunges, squats, band exercises). The last part is dedicated to relaxation and stretching. Progression may be achieved by increasing resistance, reducing rest intervals, or increasing the number of exercises or repetitions. Participants must not experience any discomfort, tingling, or sensation of heaviness in the arm on the side of the operated breast. APA sessions are delivered online by students holding a Bachelor's degree in Exercise and Sport Sciences (L-22), enrolled in the Master's Degree Program in Preventive and Adapted Physical Activity, and supervised by a qualified specialist in Preventive and Adapted Physical Activity. Yoga and Pilates sessions are conducted online by certified instructors.
Walking: Participants independently perform one walking session per week.
Rowing: Sessions involve a qualified instructor certified by the Italian Rowing Federation (FIC) and trained to instruct vulnerable populations, one psychologist and psychotherapist, two entry-level rowing instructors, and six volunteers trained in rowing techniques for vulnerable individuals. High-stability rowing boats designed for beginners are used (four-person, two-person, and single-person boats), with a coxswain on the four-person boats. Participants are accompanied and supervised by motorized catamarans provided by Società Canottieri Corgeno, the organization hosting the project, which allow researchers and instructors to monitor and assist participants during on-water activities. In the last three months of the intervention, participants are monitored on a rotational basis during selected rowing sessions, using indirect calorimetry, to investigate the metabolic responses to rowing.
ASSESSMENTS AND INSTRUMENTS
Medical screening: Family, physiological, and medical history; physical examination of the musculoskeletal, thoracic, respiratory, and cardiovascular systems; documentation of previous surgical procedures and injuries; resting blood pressure; and resting electrocardiogram (ECG P8000Power, Esaote, Italy). The sports medicine physician also assesses whether the participant has been undergoing psychotherapy and/or psychiatric treatment (including psychoactive medications) for less than six months. Screening is conducted at the Canottieri Corgeno rowing club, in a dedicated examination room, by a sports medicine physician from Centro Medico Loreto Nove (Milan, Italy).
Anthropometric measurements: Height and body weight are measured with a mechanical scale and a portable stadiometer (Seca models 761 and 213, Germany), with participants barefoot and wearing only underwear, and body mass index (BMI) is calculated. Waist circumference is measured at the midpoint between the lower costal margin and the iliac crest, and hip circumference at the widest part of the hips. Upper-limb circumference measurements include seven measurements along the upper arm and forearm.
Body composition is assessed by measuring skinfold thickness with a Harpenden caliper (Lanzoni, Italy). The Jackson and Pollock three-site method (triceps, suprailiac, anterior thigh) is used to estimate body density, and the Siri equation to calculate body fat percentage.
Aerobic capacity: VO2max is estimated with a direct submaximal test on a cycle ergometer, consisting of three 4-minute stages at progressively increasing workloads (30, 40, 50, 60, or 70 W depending on initial physical condition) at a cadence of 50-60 rpm. Heart rate and oxygen uptake are continuously monitored with a metabolic analyzer (K5, COSMED, Italy). At the end of each stage, perceived exertion is rated on the Borg CR10 scale. The test ends at 85% of age-predicted maximum heart rate or a rating of perceived exertion of 7 or higher. Medical personnel or highly qualified specialists are present throughout.
Handgrip strength: Maximal isometric handgrip strength is assessed with a hydraulic hand dynamometer (JAMAR, Lafayette Instrument, USA): three maximal voluntary contractions of up to 3 seconds per hand, separated by 60 seconds of rest.
Flexibility: V-Sit-and-Reach Test and Back Scratch Test.
Questionnaires: Administered on two separate days (day 1: GPAQ, EORTC QLQ-C30, EORTC QLQ-FA12; day 2: PACES, RSES, and Life Tasks Questionnaire), in a dedicated room, in the presence of a psychologist registered with the Order of Psychologists of the Lombardy Region, for about 45 minutes in total.
Global Physical Activity Questionnaire (GPAQ): 16 questions developed by the World Health Organization on sedentary behavior and physical activity at work, in travel, and in recreation.
EORTC QLQ-C30: 30-item cancer-specific questionnaire assessing global health status/quality of life, five functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, pain, nausea/vomiting), and other cancer-related symptoms and problems.
EORTC QLQ-FA12: 12-item questionnaire assessing the physical, cognitive, and emotional dimensions of cancer-related fatigue and its interference with daily and social life in the previous week.
Physical Activity Enjoyment Scale (PACES): 16 items on a 5-point Likert scale assessing enjoyment of PA. It is administered at baseline and after each training session.
Rosenberg Self-Esteem Scale (RSES): 10 statements assessing self-worth and self-satisfaction (items scored 0-3, negatively worded items reverse-scored).
Self-Assessment Questionnaire on Life Tasks According to Individual Psychology: three self-administered questions on work, friendship, and love and sexuality, rated on a 5-point Likert scale.
Training sessions: At the end of each session (30 minutes post-exercise), the session rating of perceived exertion (session-RPE) is assessed. During the last three months, heart rate and oxygen uptake are continuously monitored during selected rowing sessions, on a rotational basis, using a portable metabolic analyzer (K5, COSMED, Italy
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Università Cattolica di Milano is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Participants will be considered eligible for the study if they meet the following criteria:
The exclusion criteria will include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-arm, six-month exercise therapy program for women aged 40-65 who have undergone breast cancer surgery and completed post-surgical treatments. Each week, participants perform three hours of exercise: one hour of supervised on-water rowing, one hour of independent walking, and one hour of online adapted physical activity (APA), yoga, or Pilates. For each training session, groups include a maximum of 10 women. Rowing is performed in high-stability beginner boats (single, double, and coxed four) with certified rowing instructors, a psychologist, and trained volunteers, accompanied by motorized support boats. Online APA sessions include joint mobility, postural control, and progressive functional strengthening with bodyweight, light weights (0.5-1 kg), or elastic bands (1.3-1.7 kg). Exercise is adapted to each participant's baseline activity level and progresses gradually. Assessments are performed at baseline, 3 months, and 6 months.
Other: Behavioral Rowing-based exercise therapy program
Six-month multimodal program, three hours per week. Rowing (1 h/week, on water): led by an Italian Rowing Federation-certified instructor with a psychologist and trained volunteers, with gradual progression from technique introduction in stable boats. Walking (1 h/week): independent. Online session (1 h/week): APA or yoga/Pilates. APA sessions start with joint mobility and muscle activation, then circuits of 4-5 exercises (8-10 repetitions for limb exercises; 30-second planks and crunches; 40 s rest between rounds, 2 min between circuits) with bodyweight, bands or light weights, and end with relaxation and stretching. Progression: more resistance, shorter rests, or added exercises/repetitions, guided by weekly feedback. Exercises are modified if arm discomfort, tingling or heaviness occurs on the operated side. APA is delivered by Master's students under specialist supervision; yoga/Pilates by certified instructors.
Change in estimated maximal aerobic capacity (VO2max)
VO2max is estimated from a direct submaximal exercise test on a cycle ergometer, consisting of three 4-minute stages at progressively increasing workloads (30 to 70 W, depending on initial fitness) at 50-60 rpm. Oxygen uptake and heart rate are measured continuously with a portable metabolic analyzer (K5, COSMED). The test is stopped at 85% of age-predicted maximum heart rate or a Borg CR10 rating of perceived exertion of 7 or higher. Change from baseline is evaluated at 3 and 6 months.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in health-related quality of life (EORTC QLQ-C30)
Health-related quality of life is assessed with the EORTC QLQ-C30, a 30-item self-administered cancer-specific questionnaire. It includes a global health status/quality of life scale, five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, pain, nausea/vomiting), and single items on cancer-related symptoms and problems (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). All scales are scored from 0 to 100; higher scores on the global health status and functional scales indicate better functioning, while higher scores on the symptom scales indicate more severe symptoms. Change from baseline is evaluated at 3 and 6 months.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in self-esteem (Rosenberg Self-Esteem Scale)
The Rosenberg Self-Esteem Scale consists of 10 statements assessing self-worth and satisfaction with oneself. Positively worded items are scored from 0 (strongly disagree) to 3 (strongly agree); negatively worded items are reverse-scored.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in enjoyment of physical activity (PACES)
The Physical Activity Enjoyment Scale (PACES) consists of 16 items rated on a 5-point Likert scale and assesses the level of enjoyment experienced during physical activity. It is administered at baseline and after each training session.
Time frame: Baseline (T0), after each training session, 3 months (T1), and 6 months (T2)
Metabolic responses to rowing (oxygen uptake and heart rate)
During selected rowing sessions, participants are monitored on a rotational basis using a portable metabolic analyzer (K5, COSMED), which continuously records oxygen uptake and heart rate through indirect calorimetry.
Time frame: During selected rowing sessions in the last three months of the intervention (months 4 to 6)
Change in maximal isometric handgrip strength
Maximal isometric handgrip strength is measured bilaterally (right and left hand) with a hydraulic hand dynamometer (JAMAR). Participants perform three maximal voluntary contractions of up to 3 seconds per hand, separated by 60 seconds of rest.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in flexibility (V-Sit-and-Reach and Back Scratch tests)
Flexibility is assessed with the V-Sit-and-Reach Test and the Back Scratch Test.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in body composition (body fat percentage)
Skinfold thickness is measured with a Harpenden caliper at three sites (triceps, suprailiac, anterior thigh). Body density is estimated with the Jackson and Pollock three-site method, and body fat percentage is calculated with the Siri equation.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in anthropometric measures (body mass index, waist, hip, and upper-limb
Height and body weight are measured with a mechanical scale and a portable stadiometer to calculate body mass index (kg/m2). Waist circumference is measured at the midpoint between the lower costal margin and the iliac crest, and hip circumference at the widest part of the hips. Upper-limb circumference is measured at seven points along the upper arm and forearm.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in functional and symptom scales of quality of life (EORTC QLQ-C30)
The EORTC QLQ-C30 assesses five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, pain, nausea/vomiting), and single items on cancer-related symptoms and problems (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Scores range from 0 to 100.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Number of exercise-related adverse events (safety)
The number of adverse events related to physical exercise, the underlying disease, and its treatments is recorded throughout the intervention.
Time frame: From enrollment to 6 months
Adherence to the program
Adherence is defined as the percentage of scheduled training sessions completed by each participant. It is considered satisfactory if at least 75% of scheduled sessions are completed
Time frame: From the start of the intervention to 6 months
Plan to share: No — individual participant data will not be shared to protect patient privacy and in accordance with the informed consent form.
Ran from Apr 2023 to primary completion in Nov 2023, 7 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 7 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Università Cattolica di Milano