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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05206526
Other study ID # DRACARYS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date September 30, 2021

Study information

Verified date January 2022
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 30, 2021
Est. primary completion date September 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Home-based Exercise
12 weeks of home-based training composed by 10 exercises.

Locations

Country Name City State
Italy Nutrition and Exercise Lab, DSB, University of Padova Padova

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lean body mass kilograms of muscle mass measure by bioimpendenziometry Change from baseline to up to 3 months
Primary cardiovascular fitness meters walked during the 6 minutes walking test Change from baseline to up to 3 months
Primary body appreciation 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
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