- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024280
Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors (MamaMoveGaia)
February 15, 2022 updated by: Ana Joaquim, Associacao de Investigacao de Cuidados de Suporte em Oncologia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oporto
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Vila Nova de Gaia, Oporto, Portugal, 4434-502 Vila Nova de Gaia
- Centro Hospitalar de Vila Nova de Gaia/Espinho
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
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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.
|
Week 8
|
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.
|
Week 16
|
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.
|
Week 24
|
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.
|
Week 32
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ana Joaquim, MD, Centro Hospitalar de Vila Nova de Gaia/Espinho
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
July 6, 2019
First Submitted That Met QC Criteria
July 16, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAMA_MOVE_Gaia After Treatment
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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