Breast CancerNCT05206526
Dragonboat Activity for Breast Cancer
A study testing Dragon Boat and Home-based Exercise in people with Breast Cancer, run by University of Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dragon Boat and Home-based Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2021to 30 Sep 2021
- 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 45-70 years
- Body mass index: <18 and <30 kg / m2
- Diagnosis and treatment for breast cancer
Who cannot join
- Other corneal diseases (cardiovascular, hepatic, respiratory)
- Participation in other structured exercise programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Dragon Boat, Home-based Exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dragon BoatBehavioural
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 ExerciseBehavioural
12 weeks of home-based training composed by 10 exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Home-based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
kilograms of muscle mass measure by bioimpendenziometry
Measured: Change from baseline to up to 3 months
cardiovascular fitness
meters walked during the 6 minutes walking test
Measured: 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)
Measured: Change from baseline to up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start15 May 2021
- Primary completion15 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206526
- Sponsor's protocol ID
- DRACARYS
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38456933
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRagonboat Activity for CAncer RecoverY and Self-efficacy
- ClinicalTrials.gov ID
- NCT05206526
- Acronym / sponsor ID
- DRACARYS
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 25 Jan 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dragon Boat | Experimental | Behavioral: Dragon Boat12 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. |
| Control | Active comparator | Behavioral: Home-based Exercise12 weeks of home-based training, without supervision, to perform 3 time per week composed by ten total body exercise. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 45-70 years
- Body mass index: <18 and <30 kg / m2
- Diagnosis and treatment for breast cancer
Key exclusion criteria (2 listed)
- Other corneal diseases (cardiovascular, hepatic, respiratory)
- Participation in other structured exercise programs
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 |
|---|---|---|
| Dragon Boat12 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. | Behavioural | Dragon Boat |
| Home-based Exercise12 weeks of home-based training composed by 10 exercises. | Behavioural | Control |
Primary outcome
Lean body mass
Time frame: Change from baseline to up to 3 months
kilograms of muscle mass measure by bioimpendenziometry
cardiovascular fitness
Time frame: Change from baseline to up to 3 months
meters walked during the 6 minutes walking test
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)
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 10 Feb 2022.
- Derived from this study: PubMed 38456933Moro 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dragon Boat and Home-based Exercise in people with Breast Cancer, run by University of Padova at 1 site in Italy.
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 3 inclusion and 2 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 10 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 Italy. 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?
Lean body mass (time frame: Change from baseline to up to 3 months). The study lists 3 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 NCT05206526, which also lists 1 linked publication.
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 10 Feb 2022; AzTrials last refreshed its copy on 4 Nov 2026.