Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors

NCT04337736 | Completed

• 1 other identifier: BCSPHE001
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

To examine the effects of different physical exercise protocols (aerobic training and resistance training) on cardio-vascular efficiency and quality of life in a population of breast cancer survivors (BCS), not treated with chemotherapy.

Conditions

Breast Cancer Female

Keywords

Physical exercise; Adherence to physical exercise; Global longitudinal strain; Ventricular-arterial coupling; Arterial stiffness; Epicardial fat thickness; Intima-media thickness; Endocrine therapy

Outcome Measures

Primary Outcomes (1)

• Improvement of cardio-vascular efficiency

  A composite of the improvement in the following parameters, from pre-treatment values: global longitudinal strain analysis, as assessed by speckle-traking echocardiography; ventricular-arterial coupling, as assessed by echocardiographic single beat method; arterial stiffness (pulse wave velocity, augmentation index), as assessed by photoplethysmographic method

  12-weeks (from the beginning of physical exercise training)

Secondary Outcomes (5)

• Epicardial fat thickness reduction

  12-weeks (from the beginning of physical exercise training)

• Intima-media thickness reduction

  12-weeks (from the beginning of physical exercise training)

• Improvement of quality of life

  12-weeks (from the beginning of physical exercise training); a mean of 34 months from the enrollment

• Improvement of spontaneous physical activity

  a mean of 34 months from the enrollment

• Improvement of cardiovascular quality of life

  a mean of 34 months from the enrollment

Study Arms (2)

Aerobic training

ACTIVE COMPARATOR

12-weeks, 3-days-a week, supervised aerobic (Nordic walking or Walking) physical exercise (PhE) protocol; duration of each PhE session: 70 minutes; rate of perceived exertion (RPE): 10-11 (1st-4th week); 12-13 (5th-8th week); 13-14 (9th-12th week).

Other: Physical exercise

Resistance training

ACTIVE COMPARATOR

12-weeks, 2.3-days-a week (total of 28 lessons), supervised resistance physical exercise (PhE) protocol; duration of each PhE session: 50 minutes.

Other: Physical exercise

Interventions

Physical exercise OTHER

Aerobic training; Resistance training

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age \< 65 years;
• history of breast cancer surgery in the previous 12 months;
• no history of chemotherapy;
• no ongoing radiotherapy;
• eventual hormonal therapy;
• cardiovascular and orthopedic eligibility.

You may not qualify if:

• adjuvant chemotherapy;
• any history of cardiovascular disease;
• abnormal exercise stress test at the screening;
• any systemic inflammatory disease or any orthopedic condition potentially limiting the physical training.

Sponsors & Collaborators

• ITAB - Institute for Advanced Biomedical Technologies: lead

Related Publications (5)

• Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available.

  PMID: 27567406 BACKGROUND

• Khosrow-Khavar F, Filion KB, Al-Qurashi S, Torabi N, Bouganim N, Suissa S, Azoulay L. Cardiotoxicity of aromatase inhibitors and tamoxifen in postmenopausal women with breast cancer: a systematic review and meta-analysis of randomized controlled trials. Ann Oncol. 2017 Mar 1;28(3):487-496. doi: 10.1093/annonc/mdw673.

  PMID: 27998966 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 BACKGROUND

• Zhu G, Zhang X, Wang Y, Xiong H, Zhao Y, Sun F. Effects of exercise intervention in breast cancer survivors: a meta-analysis of 33 randomized controlled trails. Onco Targets Ther. 2016 Apr 13;9:2153-68. doi: 10.2147/OTT.S97864. eCollection 2016.

  PMID: 27110131 BACKGROUND

• Scott JM, Nilsen TS, Gupta D, Jones LW. Exercise Therapy and Cardiovascular Toxicity in Cancer. Circulation. 2018 Mar 13;137(11):1176-1191. doi: 10.1161/CIRCULATIONAHA.117.024671.

  PMID: 29530893 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Francesco Bianco, MD, PhD

  ITAB - Institute for Advanced Biomedical Technologies

  PRINCIPAL INVESTIGATOR

• Valentina Bucciarelli, MD, PhD

  ITAB - Institute for Advanced Biomedical Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 8, 2020
• Study Start: April 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: March 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share