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出境医 / 临床实验 / Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors (MamaMoveGaia)
Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors (MamaMoveGaia)
Study Description
Brief Summary:
A 16 weeks 3-weekly supervised and adapted physical exercise program will be applied to breast cancer survivors in surveillance and, in estrogen receptor positive cases, under hormonotherapy. The program will be applied in group classes of 20 participants, in the facilities of one local gymnasium, by fitness instructors included in the investigation team. Investigators will evaluate the Health-Related Quality of Life (HRQoL), physical activity, cardiopulmonary fitness, upper limb strength and lower limb functionality. The investigators also aim to evaluate the safety of the program and oncological outcomes such as symptoms related to disease and its treatment and, also, overall survival and disease free survival.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Quality of Life Physical Exercise | Other: Physical exercise program | Not Applicable |
Detailed Description:
This protocol describes a two-arm prospective non randomized trial that will test the HRQoL effect of a 16 weeks 3-weekly supervised and adapted physical exercise program that combines muscle strength and aerobic training with progressive intensity. The benefits of physical exercise programs in breast cancer survivors is well known. However, the studied programs usually are not generalizable because of needs of specialized exercise professionals and materials. The investigators aim to evaluate if it is possible to obtain the same benefits in HRQoL, physical activity, cardiopulmonary fitness, upper limb strength and lower limb functionality when the program is applied in group classes by trained fitness instructors with exercise strategies based in limited material. Maximum participants of each group class is 20. Each participant will pass through a 16 weeks control phase, during which should maintain the usual physical activity and, then, through a 16 weeks study phase, during which undergoes the physical exercise program. In each phase, the participants will be serially evaluated. During the 32 weeks, each participant will pass through 5 evaluation moments: at baseline, at 8 weeks, at 16 weeks before beginning the study phase, at 8 weeks of physical exercise and 16 weeks of physical exercise at the end of the program. After, investigators aim to evaluate each participant at 3, 6 and 12 months ant, then, yearly.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors |
| Actual Study Start Date : | July 1, 2018 |
| Actual Primary Completion Date : | February 1, 2020 |
| Estimated Study Completion Date : | June 1, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention arm
Patients will perform a supervised physical exercise program specifically developed for breast cancer patients, based on the guidelines of the American College of Sports Medicine. The physical exercise program comprises 3 weekly sessions of 60 minutes each. Each session will involve an initial warm-up with light mobility exercises, followed by resistance and aerobic training and ending with a return to calm phase of light stretching exercises.
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Other: Physical exercise program
Frequency: 3 weekly sessions. Intensity of aerobic training: reporting 12-17 in the Borg scale. Time of aerobic training: 10 minutes in the first and second weeks and then 2 added minutes at each 2 weeks. Type of aerobic training: walking and stepping. Intensity of resistance training: without load in the first week and, then, 15 submaximal repetitions. Time of resistance training: 30 minutes. Type of resistance training: using free weights; the lower body exercises will be squat, leg extension, leg curl and calf raise; the upper body exercises will be frontal and lateral arm raise, chest press, seated row and bicep curl.
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No Intervention: Control arm
Patients should maintain the usual physical activity
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Outcome Measures
Primary Outcome Measures :
- Health Related Quality of Life [ Time Frame: Baseline ]European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100.A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
- Health Related Quality of Life [ Time Frame: Week 8 ]European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100.A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
- Health Related Quality of Life [ Time Frame: Week 16 ]European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100.A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
- Health Related Quality of Life [ Time Frame: Week 24 ]European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100.A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
- Health Related Quality of Life [ Time Frame: Week 32 ]European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100.A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological diagnosis of breast carcinoma
- Stages 0 to IIIC
- Having undergo primary treatment with curative intent, defined as surgery that can have been complemented with neoadjuvant, or adjuvant, chemotherapy and/or radiotherapy
- Conclusion of the last of the following treatments at least one month before: surgery, chemotherapy or radiotherapy
- At least one consultation in the Medical Oncology Department of the Centro Hospitalar de Vila Nova de Gaia/Espinho
- Assistant medical oncologist consent for the physical exercise practice
- Not meeting the physical activity guidelines of the American College of Sports Medicine (moderate activity ≥ 150 minutes/week ou vigorous activity ≥ 75 minutes/week and ≥ 2 resistance training/week).
Exclusion Criteria:
- Severe anemia (Hb ≤ 8 g/dL)
- Symptomatic moderate anemia (Hb >8 and ≤ 10 g/dL); considered symptoms are: sustained tachycardia, exertion dyspnea, thoracic pain or syncope
- Uncontrolled hypertension
- Uncontrolled diabetes
- Cardiac failure grade >1 in the New York Heart Association evaluation
- History of osteoporosis with Tscore <-2.5 in the lumbar spine and/or femur in the menopause
- Contraindication given by the assistant surgeon
Contacts and Locations
Locations
| Portugal | |
| Centro Hospitalar de Vila Nova de Gaia/Espinho | |
| Vila Nova de Gaia, Oporto, Portugal, 4434-502 Vila Nova de Gaia | |
Sponsors and Collaborators
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Centro Hospitalar de Vila Nova de Gaia/Espinho
Aveiro University
University Institute of Maia
Investigators
| Principal Investigator: | Ana Joaquim, MD | Centro Hospitalar de Vila Nova de Gaia/Espinho |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 6, 2019 | ||||
| First Posted Date ICMJE | July 18, 2019 | ||||
| Last Update Posted Date | January 15, 2021 | ||||
| Actual Study Start Date ICMJE | July 1, 2018 | ||||
| Actual Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors | ||||
| Official Title ICMJE | Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors | ||||
| Brief Summary | A 16 weeks 3-weekly supervised and adapted physical exercise program will be applied to breast cancer survivors in surveillance and, in estrogen receptor positive cases, under hormonotherapy. The program will be applied in group classes of 20 participants, in the facilities of one local gymnasium, by fitness instructors included in the investigation team. Investigators will evaluate the Health-Related Quality of Life (HRQoL), physical activity, cardiopulmonary fitness, upper limb strength and lower limb functionality. The investigators also aim to evaluate the safety of the program and oncological outcomes such as symptoms related to disease and its treatment and, also, overall survival and disease free survival. | ||||
| Detailed Description | This protocol describes a two-arm prospective non randomized trial that will test the HRQoL effect of a 16 weeks 3-weekly supervised and adapted physical exercise program that combines muscle strength and aerobic training with progressive intensity. The benefits of physical exercise programs in breast cancer survivors is well known. However, the studied programs usually are not generalizable because of needs of specialized exercise professionals and materials. The investigators aim to evaluate if it is possible to obtain the same benefits in HRQoL, physical activity, cardiopulmonary fitness, upper limb strength and lower limb functionality when the program is applied in group classes by trained fitness instructors with exercise strategies based in limited material. Maximum participants of each group class is 20. Each participant will pass through a 16 weeks control phase, during which should maintain the usual physical activity and, then, through a 16 weeks study phase, during which undergoes the physical exercise program. In each phase, the participants will be serially evaluated. During the 32 weeks, each participant will pass through 5 evaluation moments: at baseline, at 8 weeks, at 16 weeks before beginning the study phase, at 8 weeks of physical exercise and 16 weeks of physical exercise at the end of the program. After, investigators aim to evaluate each participant at 3, 6 and 12 months ant, then, yearly. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Physical exercise program
Frequency: 3 weekly sessions. Intensity of aerobic training: reporting 12-17 in the Borg scale. Time of aerobic training: 10 minutes in the first and second weeks and then 2 added minutes at each 2 weeks. Type of aerobic training: walking and stepping. Intensity of resistance training: without load in the first week and, then, 15 submaximal repetitions. Time of resistance training: 30 minutes. Type of resistance training: using free weights; the lower body exercises will be squat, leg extension, leg curl and calf raise; the upper body exercises will be frontal and lateral arm raise, chest press, seated row and bicep curl.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE |
80 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 1, 2021 | ||||
| Actual Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Portugal | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04024280 | ||||
| Other Study ID Numbers ICMJE | MAMA_MOVE_Gaia After Treatment | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Ana Joaquim, Associacao de Investigacao de Cuidados de Suporte em Oncologia | ||||
| Study Sponsor ICMJE | Associacao de Investigacao de Cuidados de Suporte em Oncologia | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Associacao de Investigacao de Cuidados de Suporte em Oncologia | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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