Effects of a 12-week strength and aerobic exercise program on muscular strength and quality of life in breast cancer survivors

ISRCTN ISRCTN14601208
DOI https://doi.org/10.1186/ISRCTN14601208
Secondary identifying numbers TRFE-SI-2019/004
Submission date
22/07/2019
Registration date
01/08/2019
Last edited
22/06/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Breast cancer is the type of cancer with the highest incidence worldwide, however, it is well treated with the survival rate nearly 90% at 5-years. As a result, the number of people living with the consequences of the disease and its treatment (loss of muscle mass and strength, shoulder joint problems, lymphedema, cardiac toxicity and decreased quality of life) increases every year. All these disease-related consequences can be improved through physical exercise, especially when resistance and cardiovascular training are combined. In order to maximize the training benefits, individualization is essential. The aim of this study is to evaluate the effects of 12 weeks of supervised resistance training combined with home-based cardiovascular training on muscular strength in women survivor of breast cancer and to assess how this intervention affects cardiorespiratory fitness, fatigue and different aspects of disease-related quality of life.

Who can participate?
Survivors of breast cancer aged 18-65 who have completed central treatments of breast cancer within the past 5 years

What does the study involve?
60 women will be randomly assigned to either an exercise group (EG) or a control group (CG). The EG which will perform two resistance training sessions per week for 12 weeks (i.e. 2 weeks of one-to-one individual training and 10 weeks in groups of 4-5 participants) and will be required to perform ~10,000 steps per day as home-based aerobic training. The CG will also be required to undertake ~10,000 steps per day as home-based aerobic training but will not perform supervised resistance training. At baseline and at week 12 (i.e. after the intervention) all participants will be assessed for upper- and lower-body muscular strength, estimated maximum oxygen consumption, usual physical activity, range of motion (i.e. shoulder flexion), presence of lymphedema, health-related quality of life, fatigue, depression, and satisfaction with life.
(updated 02/09/2019, previously: 60 women will be randomly assigned to either an exercise group (EG) or a control group (CG). The EG which will perform two resistance training sessions per week during 12 weeks (i.e. 2 weeks of one-to-one individual training and 10 weeks in groups of 4-5 participants) and will be required to meet the WHO physical activity guidelines of at least 10,000 steps per day as home-based aerobic training. The CG will be required to meet the WHO physical activity guidelines of at least 10,000 steps per day but will not undertake resistance training. At baseline and at week 12 (i.e. after the intervention) all participants will be assessed for upper- and lower-body muscular strength, estimated maximum oxygen consumption, usual physical activity, range of motion (i.e. shoulder flexion), presence of lymphedema, health-related quality of life, fatigue, depression, and satisfaction with life.)

What are the possible benefits and risks of participating?
Possible benefits include improvement of physical fitness and several aspects related to quality of life (see primary and secondary outcomes and hypotheses). Potential risks are those intrinsically associated with exercise, such as potential injuries. However, this is unlikely to occur as all sessions will be closely supervised by qualified professionals.

Where is the study run from?
1. Universidad de Almería, Spain
2. Patronato Municipal de Deportes. Ayuntamiento de Almería, Spain

When is the study starting and how long is it expected to run for?
August 2019 to December 2019

Who is funding the study?
1. Universidad de Almería, Spain
2. Patronato Municipal de Deportes. Ayuntamiento de Almería, Spain

Who is the main contact?
Dr Alberto Soriano-Maldonado
asoriano@ual.es

Contact information

Dr Alberto Soriano-Maldonado
Scientific

Universidad de Almería
Ctra. Sacramento s/n
Almería
04120
Spain

ORCiD logoORCID ID 0000-0002-4626-420X
Phone +34950214736
Email asoriano@ual.es

Study information

Study designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffects of a 12-week exercise program combining strength and aerobic training on muscular strength and quality of life in breast cancer survivors
Study acronymEFICAN
Study objectives1. Muscular strength will increase in the exercise group compared to the control group at week 12
2. Cardiorespiratory fitness will increase in the exercise group compared to the control group at week 12
3. Range of motion (i.e. shoulder flexion) will increase in the exercise group compared to the control group at week 12
4. Cancer-related fatigue and depression will decrease in the exercise group compared to the control group at week 12
5. Health-related quality of life will increase in the exercise group compared to the control group at week 12
6. Life satisfaction will increase in the exercise group compared to the control group at week 12
Ethics approval(s)Approved 31/07/2019, Ethics Committee of the Torrecárdenas University Hospital (Calle Hermandad de Donantes de Sangre, 04009, Almería, Spain; +34 950 016 000; al42_cetico_cht.hto.sspa@juntadeandalucia.es), ref: Ejercicio-CáncerUAL(98/2019)
Health condition(s) or problem(s) studiedBreast cancer survivors
InterventionCurrent interventions as of 02/09/2019:
The study is a randomized controlled trial. Patients will be randomly assigned to either an exercise group (combining supervised strength training and home-based aerobic training) or a control group. A simple randomization sequence will be generated by computer. Each participant will be randomized after meeting the inclusion criteria, signing the informed consent, and performing the baseline (pre-test) assessment. Baseline assessments (pre-test) will be carried out within 15 days before the start of the intervention, and follow-up assessment will be performed at the end of the intervention (week 12).
Due to the nature of the intervention (i.e. exercise), it will not be possible to mask allocation to the patients. Investigator will be blinded to the participants' allocation.

Exercise group: 12 weeks of exercise combining supervised strength training and home-based aerobic training. The sessions will begin with a warm-up including five minutes of cardiovascular work on a treadmill or cycle ergometer, and about 10 minutes including thoracic mobility, core stability, scapulohumeral joint stability, and dynamic stability exercises. Thereafter, a strength training block will be conducted including two sets of eight repetitions of seven exercises including squat, chest press, deadlift, seated row, leg press, triceps extensions and lat pulldown (specific adaptations will be carried out whenever necessary). The intensity will be set at six out of 10 in the OMNI perceived exertion scale for resistance exercise. The first two weeks will be aimed at familiarization with basic movement patterns and will be on a one-to-one basis. From week three to week 12, there will be group sessions (i.e. 4-5 participants per group). The home-based aerobic training will consist of performing ~10,000 steps per day.

Control group: usual care including healthy lifestyle recommendations. In addition, the control group will receive indications to perform ~10,000 steps per day to meet the physical activity guidelines.

Previous interventions:
The study is a randomized controlled trial. Patients will be randomly assigned to either an exercise group (combining supervised strength training and home-based aerobic training) or a control group. A simple randomization sequence will be generated by computer. Each participant will be randomized after meeting the inclusion criteria, signing the informed consent, and performing the baseline (pre-test) assessment. Baseline assessments (pre-test) will be carried out within 15 days before the start of the intervention, and follow-up assessment will be performed at the end of the intervention (week 12).
Due to the nature of the intervention (i.e. exercise), it will not be possible to mask allocation to the patients. Investigator will be blinded to the participants' allocation.

Exercise group: 12 weeks of exercise combining supervised strength training and home-based aerobic training. The sessions will begin with a warm-up including five minutes of cardiovascular work on a treadmill or cycle ergometer, and about 10 minutes including thoracic mobility, core stability, scapulohumeral joint stability, and dynamic stability exercises. Thereafter, a strength training block will be conducted including two sets of eight repetitions of seven exercises including squat, chest press, deadlift, seated row, leg press, triceps extensions and lat pulldown (specific adaptations will be carried out whenever necessary). The intensity will be set at six out of 10 in the OMNI perceived exertion scale for resistance exercise. The first two weeks will be aimed at familiarization with basic movement patterns and will be on a one-to-one basis. From week three to week 12, there will be group sessions (i.e. 4-5 participants per group). The home-based aerobic training will consist of performing a minimum of 10,000 steps per day to meet the WHO physical activity guidelines.

Control group: usual care including healthy lifestyle recommendations. In addition, the control group will receive indications to perform a minimum of 10,000 steps per day to meet the WHO physical activity guidelines.
Intervention typeBehavioural
Primary outcome measureMuscular strength assessed at baseline and week 12:
1. Upper-body muscular strength will be a standardized score computed as the average of the normalized score (z-score = [value-mean] / standard deviation) of 2 different exercise tests, including:
- Sum of right and left unilateral isometric seated bench press. Muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain).
- Sum of right and left unilateral isometric seated row. Muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain).
2. Lower-body muscular strength will be a standardized score computed as the average of the normalized score (z-score = [value-mean] / standard deviation) of 2 different exercise tests, including:
- Sum of right and left unilateral isometric knee extension in closed kinetic chain at 90º (average of the right and left knees). Muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain).
- Mid-thigh isometric pull test. Bilateral muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain).
3. Overall muscular strength will be a standardized score computed as the average of the normalized score (z-score = [value-mean] / standard deviation) of the above-mentioned upper- and lower-body exercise tests.
Secondary outcome measuresAt baseline and week 12:
1. Other Muscular strength measures:
1.1. Bilateral isometric seated bench press measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain).
1.2. Isometric seated bench press bilateral deficit [bilateral deficit = (100 x bilateral / (right unilateral + left unilateral)) - 100].
1.3. Bilateral isometric seated row measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain).
1.4. Isometric seated row bilateral deficit [bilateral deficit = (100 x bilateral / (right unilateral + left unilateral)) - 100].
1.5. Handgrip strength (of the right and left sides) assessed with a digital dynamometer (Model T.K.K.540®; Takei Scientific Instruments Co., Ltd, Niigata, Japan).
1.6. The difference between right unilateral and left unilateral handgrip strength, assessed with a digital dynamometer (Model T.K.K.540®; Takei Scientific Instruments Co., Ltd, Niigata, Japan).
2. Cardiorespiratory fitness assessed through the Siconolfi Step Test.
3. Shoulder range of motion: flexion. Assessed through digital goniometer (HALO medical services).
4. Disabilities of the Arm, Shoulder, and Hand (DASH), assessed through the DASH Questionnaire.
5. Quality of life will be assessed with:
5.1 European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30, including the extension for breast cancer (EORTC QLQ-BR23).
5.2 Functional Assessment of Cancer Therapy-Breast (FACT-B).
6. Cancer-related fatigue, assessed with the functional assessment of cancer therapy-fatigue (FACT-F).
7. Depressive symptoms, assessed with the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D).
8. Life satisfaction, assessed with the Satisfaction with life scale (SWLS).
9. Body composition:
9.1 Weight (in kg) and body composition (including body fat percentage, fat-free mass (kg), etc.) will be assessed with a bioelectrical impedance device (InBody 120, InBody Co. Ltd., Seoul, Korea).
9.2 Hip and waist circumference will be measured with an anthropometric tape (Harpenden, Holtain Ltd, Wales, United Kingdom). Waist-to-height ratio and waist-to-hip ratio will be calculated.
9.3 Body mass index will be calculated (kg/m²).
Overall study start date09/07/2019
Completion date31/12/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexFemale
Target number of participants60
Total final enrolment60
Key inclusion criteria1. Women aged 18-65
2. Have undergone breast cancer surgery and have finished core treatment (i.e. chemotherapy and/or radiotherapy) in the past 5 years
Key exclusion criteria1. Metastatic breast cancer.
2. Not awaiting breast reconstruction in the following 6 months.
3. Any pathology that might prevent them from exercising:
3.1 Decompensated heart failure.
3.2 Unstable ischemic heart disease.
3.3 Severe untreated high blood pressure.
3.4 Moderate-severe valvulopathies.
3.5 Aortic aneurysm.
3.6 Moderate-severe COPD
3.7 Pulmonary hypertension.
3.8 Chronic respiratory insufficiency.
4. Patients who perform more than 300 minutes per week of structured exercise
Date of first enrolment12/08/2019
Date of final enrolment01/09/2019

Locations

Countries of recruitment

  • Spain

Study participating centres

Universidad de Almería
Ctra. Sacramento s/n.
Almería
04120
Spain
Patronato Municipal de Deportes - Ayuntamiento de Almería
Calle Alcalde Santiago Martínez Cabrejas, 5
Estadio Juegos Mediterráneos
Almería
04007
Spain

Sponsor information

University of Almería
University/education

Ctra. Sacramento s/n
Almería
04120
Spain

Phone +34950015550
Email vicerrector.investigacion@ual.es
Website https://www.ual.es/
ROR logo "ROR" https://ror.org/003d3xx08
Patronato Municipal de Deportes. Ayuntamiento de Almería.
Government

C/ Alcalde Santiago Martínez Cabrejas nº 5
Almería
04007
Spain

Phone 950332100
Email pmdalmeria@aytoalmeria.es
Website http://www.pmdalmeria.org/

Funders

Funder type

University/education

Universidad de Almería

No information available

Patronato Municipal de Deportes. Ayuntamiento de Almería

No information available

Results and Publications

Intention to publish date01/11/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe results will be presented at national and international conferences and will be published in peer reviewed international journals.
IPD sharing planThe datasets generated during and/or analysed during the current study will not be publicly available. Proposals should be directed to the principal investigator (PI) Dr Alberto Soriano-Maldonado (asoriano@ual.es). To gain access, data requestors will likely need to sign a data access agreement. The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Individual participant data underlie the results reported in the published article after deidentification (text, tables, figures and appendices) will be shared. The data will be available from 9 months to 36 months following article publication. The data will be shared to achieve aims in the approved proposal.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/11/2019 Yes No
Results article 22/03/2022 21/06/2022 Yes No

Editorial Notes

22/06/2022: Internal review.
21/06/2022: The following changes have been made:
1. Publication reference added.
2. The trial acronym has been added.
05/11/2019: Publication reference added.
08/10/2019: The total final enrolment was added.
02/09/2019: The following changes were made to the trial record:
1. The interventions were changed.
2. The plain English summary was updated to reflect these changes.
15/08/2019: Internal review.
23/07/2019: Trial’s existence confirmed by Junta de Andalucia (Regional Government of Andalucia)