Clinical trial NCT05455385: The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study
Official title: The Added Value of a Third Supervised Training Session (Ground Exercises or Hydrotherapy) to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: rehabilitation
hydrotherapy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm randomized controlled trial
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Shoulder mobility
timeFrame: 12 weeks
measure: Arm volume
timeFrame: 12 weeks
measure: Force based on handgrip strength
timeFrame: 12 weeks
measure: Flexibility by means of the sit-and-reach test
timeFrame: 12 weeks
measure: Exercise capacity based on 6-minute walk test
timeFrame: 12 weeks
measure: Body image using the Body Image Scale
timeFrame: 12 weeks
measure: self-reported pain using the Brief Pain Inventory
timeFrame: 12 weeks
measure: Fatigue using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
timeFrame: 12 weeks
measure: Anxiety and depression using the Hospital Anxiety and Depression Scale
timeFrame: 12 weeks
measure: Quality of life using the McGill Quality Of Life questionnaire
timeFrame: 12 weeks
measure: Physical functioning using the Patient-Reported Outcomes Measurement Information System
timeFrame: 12 weeks
measure: Patient Specific Complaints
timeFrame: 12 weeks
measure: Global Perceived Effect
timeFrame: 12 weeks
measure: Attendance: number of times the participant was present
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: KU Leuven
name: An De Groef, Prof
role: PRINCIPAL_INVESTIGATOR
References: