Resistance training as prehabilitation exercise in Mamma-CA
- Conditions
- Post-OP complicationsHealth related quality of life, FatiqueAnxiety and depression,lymphedemapolyneuropathie
- Registration Number
- DRKS00023243
- Lead Sponsor
- niklinik Köln, Centrum für integrierte Onkologie (CIO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 66
• diagnosed breast cancer
• at least 12 weeks prior to surgical therapy (breast-conserving therapy (BET) or radical mastectomy with axillary dissection)
• neo-adjuvant chemotherapy or neo-adjuvant radio-chemotherapy
• Written and valid declaration of consent from the patient
• Age> = 18 years
• Neo-adjuvant radiotherapy alone
• relapse
• Second malignancies
• WHO / ECOG performance status> 1
• Life expectancy <5 months
• ductal carcinoma
• metastases
• All illness situations that do not allow hypertrophy training, in particular:
o Clinically manifest heart failure (NYHA III-IV)
o Partial or global respiratory failure
o Permanent thrombocytopenia <10,000 / µl, e.g. refractory autoimmune thrombocytopenias.
o Congenital or acquired thrombocytopathies or coagulation disorders.
o Symptomatic CHD (exercise ECG recommended if necessary)
o Severe refractory hypertension
o Non-adjustable COPD
o severe osteoporosis
o acute migraines, epilepsy, dizziness
• Taking antidepressants (SSRIs) and other drugs that affect quality of life
• Medical or psychological condition (psychomotor deficits) that does not allow the patient to take part in the study
• unwillingness to pass on personal illness data within the framework of the protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this study is to test whether pre-rehabilitation hypertrophy training consisting of strength training for the upper extremities (m. Biceps brachii, m. Triceps brachii, m. Pectoralis) in combination with vibration training for hands and feet has a positive effect on the postoperative recovery process (End point: post-op complications).
- Secondary Outcome Measures
Name Time Method Improvement of quality of life (EORTC QLQ-C30, BR23) and fatigue syndrome (MFI 20)<br>Reduction of pain, sleep disorders, anxiety, depression, nausea and vomiting (HADS Score)<br>Reduction of postmenopausal symptoms<br>Influence on lymphedema and shoulder-arm morbidity<br>Improvement of the strength level (hand grip strength test, two-handed)<br>Number of days in hospital<br>Influence on chemotherapy-induced polyneuropathies PNP (FACT CogNXT)<br>BIA<br>Movement behavior (BSA)<br><br>The assessments will take place on 4 occasions during the trial:<br><br>T0 - 12 weeks pre-OP<br>T1 - 1 weeks pre- OP<br>T2 - 1 weeks post-OP<br>t3 - 4 weeks Post-OP<br>