Prehabilitation in Patients Suffering From Gynecological Cancers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High intensity interval group
|
Other: bicycle ergometer training with different intensities
Following a 10-min warm-up phase at a constant work load below ventilatory threshold, participants of the high intensity interval group perform repeated high intensity exercise bouts, followed by an active recovery on a bicycle ergometer. The comparative group perform a constant moderate intensity with the same mean workload. The cool-down phase is 5 min with a constant work load for both groups.
|
| Active Comparator: Moderate continous intensity group
|
Other: bicycle ergometer training with different intensities
Following a 10-min warm-up phase at a constant work load below ventilatory threshold, participants of the high intensity interval group perform repeated high intensity exercise bouts, followed by an active recovery on a bicycle ergometer. The comparative group perform a constant moderate intensity with the same mean workload. The cool-down phase is 5 min with a constant work load for both groups.
|
| No Intervention: non-exercising group
|
Outcome Measures
Primary Outcome Measures
- adherence to the exercise intervention [4 to 8 weeks]
rate of completed exercise sessions as a measure of feasibility and acceptance
Secondary Outcome Measures
- 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
- Cholesterol [4 to 8 weeks]
Laboratory parameter in mg/ml as a part of the evaluation for cardiovascular risk factors
- 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
- Brain natriuretic peptide [4 to 8 weeks]
Laboratory parameter in pg/ml as a part of the evaluation for cardiovascular risk factors
- 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
- interleukin 6 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
histopathologically verified cervical carcinoma (ICD10-C53) or
-
endometrial carcinoma (ICD10-C54) or
-
ovarian carcinoma (ICD10-C56)
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planned primary/adjuvant surgery or medical training therapy
-
oncological release for medical training therapy
-
Eastern cooperative oncology group performance status (ECOG) 0-II
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Age >18a to 80
-
mental aptitude to participate in the study
Exclusion Criteria:
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serious orthopaedic, rheumatological, neurological, oncological and cardiovascular diseases which are incompatible with a training intervention
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general contraindications for exercise ergometry according to the guidelines of the austrian society of cardiology
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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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Stefano Palma, MD, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Prehab