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 |
|---|---|
| Oslo University Hospital | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| University of Oslo | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the effects of aerobic exercise to usual care in women treated with chemotherapy and radiation therapy for non-metastatic breast cancer
In this study, we will compare the effects of exercise between women previously treated with breast cancer to women with no history of any cancers. Therefore, in addition to a randomized controlled trial in women with previous breast cancer (i.e., an exerciser group and a control group), we also include a reference group comprising age-matched women with no history of any cancer diagnosis. Women in the reference group will undergo a similar exercise intervention and the exercise group. This study recruits through invitation only.
The primary endpoint in this study is the change in cardiorespiratory fitness, measured as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, endpoints derived from the cardiopulmonary exercise test and lung function assessments, cellular muscle endpoints derived from muscle biopsies obtained from m. vastus lateralis, also patient-reported outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | The aim is for participants to complete three weekly sessions of supervised aerobic treadmill based exercise for five months. Session duration varies from 20-60 minutes, with exercise intensity ranging from 55-95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate), will be determined by the CPET performed by certified exercise physiologists at baseline. |
|
| Standard care | No Intervention | Participants in this arm will not receive any follow-up on exercise during the intervention period. | |
| Reference Group | Other | Participants in this arm are age-matched women with no history of any malignant disease, which will undergo similar assessments at baseline and post-intervention and also follow similar exercise intervention as the breast cancer survivors randomized to the Aerobic exercise arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Behavioral | Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VO2peak | Peak oxygen uptake during a treadmill based cardiopulmonary exercise test | From baseline to five months (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic- and diastolic heart chamber dimensions | Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography | From baseline to five months (post-intervention) |
| Systolic- and diastolic longitudinal strain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tormod S Nilsen, PhD | The Norwegian School of Sport Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian School of Sport Sciences | Oslo | 0806 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41117797 | Derived | Johansen SH, Reinertsen KV, Wisloff T, Saeter M, Sarvari SI, Kiserud CE, Strandos N, Edvardsen E, Grydeland M, Nilsen TS, Thorsen L. Effects of aerobic exercise on late effects and quality of life in long-term breast cancer survivors: a randomized controlled trial. JNCI Cancer Spectr. 2025 Nov 3;9(6):pkaf102. doi: 10.1093/jncics/pkaf102. | |
| 39755716 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography |
| From baseline to five months (post-intervention) |
| Lean body mass | Body composition will be assessed by dual x-ray absorptiometry | From baseline to five months (post-intervention) |
| Fat mass | Body composition will be assessed by dual x-ray absorptiometry | From baseline to five months (post-intervention) |
| Blood volume | Hemoglobin mass and blood volume will be assessed using the carbon monoxide rebreathing method | From baseline to five months (post-intervention) |
| Muscle fiber type | Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry | From baseline to five months (post-intervention) |
| Muscle fiber area | Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry | From baseline to five months (post-intervention) |
| Muscle mitochondria mass | Change in mitochondrial proteins will be assessed in muscle biopsies using western blot | From baseline to five months (post-intervention) |
| Quality of life: Quality of Life Questionnaire (QLQ) C-30 | Relevant patient reported outcomes will be obtained using validated Quality of Life Questionnaire (QLQ) C-30 | From baseline to five months (post-intervention) |
| Genome-wide DNA methylation and gene expression | For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA | From baseline to five months (post-intervention) |
| Saeter M, Johansen SH, Reinertsen KV, Thorsen L, Haugaa KH, Nilsen TS, Sarvari SI. Cardiorespiratory fitness, cardiac morphology and function, and cardiovascular risk factors in long-term breast cancer survivors compared with non-cancer controls. Cardiooncology. 2025 Jan 4;11(1):1. doi: 10.1186/s40959-024-00296-0. |
| 36920460 | Derived | Nilsen TS, Saeter M, Sarvari SI, Reinertsen KV, Johansen SH, Edvardsen ER, Hallen J, Edvardsen E, Grydeland M, Kiserud CE, Lie HC, Solberg PA, Wisloff T, Sharples AP, Raastad T, Haugaa KH, Thorsen L. Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 15;12:e45244. doi: 10.2196/45244. |
| D017437 |
| Skin and Connective Tissue Diseases |