The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study

NCT ID: NCT05455385

Last Updated: 2022-07-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-05

Study Completion Date

2022-01-31

Brief Summary

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Breast cancer is the most common type of cancer diagnosed in women. A good rehabilitation program is essential for a good recovery after breast cancer, both physically and mentally. The aim of this study is to determine if there is an added value of a third supervised training session within a standard 12-week rehabilitation program to improve physical and mental functioning after breast cancer. The investigators also want to determine the added value of hydrotherapy as a third training session within a 12-week rehabilitation program compared to a third training session with ground exercises to improve physical and mental functioning after breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3-arm randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Group Type ACTIVE_COMPARATOR

standard 12-week rehabilitation program

Intervention Type OTHER

The standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks.

Hydrotherapy group

Group Type EXPERIMENTAL

standard 12-week rehabilitation program

Intervention Type OTHER

The standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks.

extra session hydrotherapy

Intervention Type OTHER

The hydrotherapy group receives 1.5h additional hydrotherapy/week in addition to the standard program.

Ground exercise group

Group Type EXPERIMENTAL

standard 12-week rehabilitation program

Intervention Type OTHER

The standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks.

extra session ground exercises

Intervention Type OTHER

The ground exercise group, receives 1.5h ground exercises/week in addition to the standard program.

Interventions

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standard 12-week rehabilitation program

The standard program consisted of 1 session in the fitness room and 1 session in the sports hall/week during 12 weeks.

Intervention Type OTHER

extra session hydrotherapy

The hydrotherapy group receives 1.5h additional hydrotherapy/week in addition to the standard program.

Intervention Type OTHER

extra session ground exercises

The ground exercise group, receives 1.5h ground exercises/week in addition to the standard program.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* men and women after surgery for breast cancer (mastectomy/breast-conserving and/or axillary gland resection/sentinel biopsy)
* possible (neo)adjuvant chemotherapy and radiotherapy have been completed
* hormone and/or immunotherapy may still be ongoing

Exclusion Criteria

* comorbidities that make hydrotherapy impossible, i.e. open wounds or allergy to chlorine
* oncological unstable disease
* terminal patients
* severe physical disabilities
* severe mental disabilities
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An De Groef, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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University Hospital Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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s63338

Identifier Type: -

Identifier Source: org_study_id

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