Breast CancerMamaMoveGaiaNCT04024280

Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors

A study testing Physical exercise program in people with Breast Cancer and Quality of Life, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Quality of Life, Physical Exercise
What is being tested?: Physical exercise program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 sitePortugal
Study dates: 1 Jul 2018to 1 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Porto District, 4434-502 Vila Nova de Gaia

Other trials in Portugal

About this study

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.

Read the 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.

Conditions: Breast Cancer, Quality of Life, Physical Exercise
Being tested: Physical exercise program
Medical subject headings: Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical exercise programOther
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.

Study groups in NCT04024280
Study group	Role	What they receive
Intervention arm	Experimental	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. Receives: Other: Physical exercise program
Control arm	No intervention	Patients should maintain the usual physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

Health Related Quality of Life
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.
Measured: Baseline
Health Related Quality of Life
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.
Measured: Week 8
Health Related Quality of Life
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.
Measured: Week 16
Health Related Quality of Life
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.
Measured: Week 24
Health Related Quality of Life
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.
Measured: Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20181 Jan 2022

First posted18 Jul 2019
Study start1 Jul 2018
Primary completion1 Feb 2020
Study completion1 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04024280
Sponsor's protocol ID: MAMA_MOVE_Gaia After Treatment
Acronym: MamaMoveGaia
Status last verified: Feb 2022
First submitted: 6 Jul 2019
Last updated: 16 Feb 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors
ClinicalTrials.gov ID: NCT04024280
Acronym / sponsor ID: MamaMoveGaia / MAMA_MOVE_Gaia After Treatment
Conditions: Breast Cancer, Quality of Life, Physical Exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em OncologiaUniversity, hospital or other
Collaborators: Centro Hospitalar de Vila Nova de Gaia/Espinho, Aveiro University, University Institute of Maia
Study start: 1 Jul 2018 (actual)
Primary completion: 1 Feb 2020 (actual)
Study completion: 1 Jan 2022 (actual)
First posted: 18 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention arm	Experimental	Other: Physical exercise programPatients 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.
Control arm	No intervention	–Patients should maintain the usual physical activity

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical exercise programFrequency: 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.	Other	Intervention arm

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.

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Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ana Joaquim, MD principal investigator

Centro Hospitalar de Vila Nova de Gaia/Espinho

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise program in people with Breast Cancer and Quality of Life, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Related Quality of Life (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.