Prehabilitation in Patients Suffering From Gynecological Cancers
- Conditions
- Prehabilitation
- Interventions
- Other: bicycle ergometer training with different intensities
- Registration Number
- NCT04618094
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
In 2016, 2216 Austrian women (= 10% of all new cancer cases) were diagnosed with gynecological tumors. Depending on stage and entity, a main primary therapy option is the surgical tumor resection. In the phase of Prehabilitation (= the time frame from diagnosis to surgical intervention) supportive therapy options such as individualized exercise interventions potentially improve recovery and postoperative outcomes after surgical interventions. The primary aim of this study is to investigate the feasibility and acceptance of a prehabilitation training intervention with high-intensity interval training compared to a conventional moderate intensity continuous training and a non-training collective. Secondary goals are the investigation of the effectiveness of threshold-based intensity prescriptions and the impact on quality of life, fatigue, anxiety, depression, sexuality and ability to work.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 45
- histopathologically verified cervical carcinoma (ICD10-C53) or
- endometrial carcinoma (ICD10-C54) or
- ovarian carcinoma (ICD10-C56)
- planned primary/adjuvant surgery or medical training therapy
- oncological release for medical training therapy
- Eastern cooperative oncology group performance status (ECOG) 0-II
- Age >18a to 80
- mental aptitude to participate in the study
- serious orthopaedic, rheumatological, neurological, oncological and cardiovascular diseases which are incompatible with a training intervention
- general contraindications for exercise ergometry according to the guidelines of the austrian society of cardiology
- osseous or cerebral metastasis
- participation in a training study in the last year or already before cancer diagnosis with high training volumes (>150min moderate / >75min more intensive endurance training per week)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate continous intensity group bicycle ergometer training with different intensities - High intensity interval group bicycle ergometer training with different intensities -
- Primary Outcome Measures
Name Time Method adherence to the exercise intervention 4 to 8 weeks rate of completed exercise sessions as a measure of feasibility and acceptance
- Secondary Outcome Measures
Name Time Method cardiovascular fitness 4 to 8 Weeks determined by VO2max
workability 4 to 8 weeks determined by the workability index questionnaire; minimum value 7, maximum value 49, higher values indicating better results
Health related Quality of life: questionnaire 4 to 8 weeks determined by the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire, minimum value 30, maximum value 126, higher scores indicating higher quality of life
Anxiety and depression 4 to 8 weeks determined by the Hospital Anxiety and Depression Scale questionnaire, minimum value 14, maximum value 56, higher values indicating higher depression levels
handgrip strength 4 to 8 weeks determined by the handgrip dynamometer
body composition 4 to 8 weeks determined by bioimpedance analysis
Thyreoglobulin 4 to 8 weeks Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors
hemoglobin A1c 4 to 8 weeks Laboratory parameter in % as a part of the evaluation for cardiovascular risk factors
Cholesterol 4 to 8 weeks Laboratory parameter in mg/ml as a part of the evaluation for cardiovascular risk factors
Brain natriuretic peptide 4 to 8 weeks Laboratory parameter in pg/ml as a part of the evaluation for cardiovascular risk factors
interleukin 6 4 to 8 weeks Laboratory parameter in ng/ml as a part of the evaluation for inflammation
Troponin T 4 to 8 weeks Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors
Creatin Kinase 4 to 8 weeks Laboratory parameter in U/l as a part of the evaluation for cardiovascular risk factors
C-reactive protein 4 to 8 weeks Laboratory parameter in mg/l as a part of the evaluation for inflammation
interleukin 1 4 to 8 Weeks Laboratory parameter in ng/ml as a part of the evaluation for inflammation
Tumor Necrosis Factor alpha 4 to 8 weeks Laboratory parameter in pg/ml as a part of the evaluation for inflammation