Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)
NCT ID: NCT05258526
Last Updated: 2022-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-04-07
2023-12-30
Brief Summary
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Detailed Description
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The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Home-based exercise program
This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.
Home based exercise training
The intervention will be based on a remote approach, lasting 12 weeks. The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week. The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.
Interventions
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Home based exercise training
The intervention will be based on a remote approach, lasting 12 weeks. The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week. The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.
Eligibility Criteria
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Inclusion Criteria
* be living in Porto Alegre or metropolitan region;
* breast cancer stage 0 - III OR
* localized prostate cancer;
* undergoing hormonal treatment / manipulation in isolation or combined with other therapies three months prior to the entrance in the study;
* hormonal therapy / manipulation planned to be active throughout the study duration;
* not engaged in any exercise training for more than once a week for the past 6 months;
* in case of previous surgical procedure, the patient must have medical clearance at the moment of the contact to begin the study or be cleared to do so in the near future (up to two weeks).
Exclusion Criteria
* inability to understand the terms and conditions of study due to language, hearing, cognitive or severe psychiatric issues;
* another family member, who lives at the same residence, participating in the study;
* planning to move or major absence (more than two weeks) during the study;
* history of cardiovascular disease (except controlled hypertension) or severe cardiopulmonary disease, as well as history of heart attack, revascularization procedures, profound venous thrombosis, encephalic vascular accident (brain stroke) or pulmonary embolism in the past twelve months;
* chronic pulmonary disease that requires oxygen or corticosteroid therapy;
* kidney disease with or that is going to begin the use of dialysis or waiting for a kidney transplant;
* severe nausea, anorexia or any other condition which does not allow to perform physical exercise;
* medical contraindication to exercise training.
18 Years
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Daniel Umpierre de Moraes, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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da Silva LXN, Leite JS, Ignacio AC, Massierer FD, Pfeifer LO, Dos Santos Cardoso LA, Alano TS, Umpierre D. The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol. Pilot Feasibility Stud. 2023 Sep 26;9(1):165. doi: 10.1186/s40814-023-01393-0.
Other Identifiers
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2021-0262
Identifier Type: -
Identifier Source: org_study_id
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