- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05206526
Dragonboat Activity for Breast Cancer
DRagonboat Activity for CAncer RecoverY and Self-efficacy
The goal of this study is to determine how a structured and supervised physical activity program linked to Dragon Boat practice can improve motivation to participate in physical activity sessions. It is also the purpose of this study to evaluate the improvement in body composition, body image perception and physical function.
For this purpose, a group of women operated on for breast cancer was recruited and divided into two experimental groups: one group participated in a structured program of Dragon Boat while the other followed a home-based program of exercises independently in the home environment.
Anthropometric measures (weight, height, BMI) and arm circumference, data on lifestyle and psychological well-being were evaluated by means of questionnaires. Tests were also performed to assess shoulder strength, aerobic capacity and mobility.
The results of this study will (a) identify the strategies used that make Dragon Boat activity effective in ensuring quality participation in physical activity, (b) define the physiological effects of Dragon Boat activity on physical functionality and (c) correlating objective measures with subjective perceptions thanks to the integration of new body composition analysis techniques (regional BIA) and validated questionnaires on the perception of body image.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Padova, Italy, 35131
- Nutrition and Exercise Lab, DSB, University of Padova
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 45-70 years
- Body mass index: <18 and <30 kg / m2
- Diagnosis and treatment for breast cancer
Exclusion Criteria:
- Other corneal diseases (cardiovascular, hepatic, respiratory)
- Participation in other structured exercise programs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dragon Boat
12 weeks of training, defined by a precise progressive, structured and supervised program divided into 3 weekly sessions of one hour / one hour and a half preparatory to the Dragon Boat activity.
|
12 weeks of training, defined by a precise progressive, structured and supervised program divided into 3 weekly sessions of one hour / one hour and a half preparatory to the Dragon Boat activity.
|
|
Active Comparator: Control
12 weeks of home-based training, without supervision, to perform 3 time per week composed by ten total body exercise.
|
12 weeks of home-based training composed by 10 exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lean body mass
Time Frame: Change from baseline to up to 3 months
|
kilograms of muscle mass measure by bioimpendenziometry
|
Change from baseline to up to 3 months
|
|
cardiovascular fitness
Time Frame: Change from baseline to up to 3 months
|
meters walked during the 6 minutes walking test
|
Change from baseline to up to 3 months
|
|
body appreciation
Time Frame: Change from baseline to up to 3 months
|
body image perception measured by the score of the Body Appreciation Scale-2 rated on a 5-point Likert-type scale ranging from Never (receiving a score of 1) to Always (receiving a score of 5)
|
Change from baseline to up to 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRACARYS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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