NCT05206526

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

January 11, 2022

Last Update Submit

January 27, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • Lean body mass

    kilograms of muscle mass measure by bioimpendenziometry

    Change from baseline to up to 3 months

  • cardiovascular fitness

    meters walked during the 6 minutes walking test

    Change from baseline to up to 3 months

  • 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

Study Arms (2)

Dragon Boat

EXPERIMENTAL

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.

Behavioral: Dragon Boat

Control

ACTIVE COMPARATOR

12 weeks of home-based training, without supervision, to perform 3 time per week composed by ten total body exercise.

Behavioral: Home-based Exercise

Interventions

Dragon BoatBEHAVIORAL

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.

Dragon Boat
Home-based ExerciseBEHAVIORAL

12 weeks of home-based training composed by 10 exercises.

Control

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 45-70 years
  • Body mass index: \<18 and \<30 kg / m2
  • Diagnosis and treatment for breast cancer

You may not qualify if:

  • Other corneal diseases (cardiovascular, hepatic, respiratory)
  • Participation in other structured exercise programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

Related Publications (1)

  • Moro T, Casolo A, Bordignon V, Sampieri A, Schiavinotto G, Vigo L, Ghisi M, Paoli A, Cerea S. Keep calm and keep rowing: the psychophysical effects of dragon boat program in breast cancer survivors. Support Care Cancer. 2024 Mar 8;32(4):218. doi: 10.1007/s00520-024-08420-7.

    PMID: 38456933DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

May 15, 2021

Primary Completion

September 15, 2021

Study Completion

September 30, 2021

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)