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Prehabilitation in Patients Suffering From Gynecological Cancers

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Medical University of Vienna

Status

Unknown

Conditions

Prehabilitation

Treatments

Other: bicycle ergometer training with different intensities

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups

High intensity interval group
Experimental group
Treatment:
Other: bicycle ergometer training with different intensities
Moderate continous intensity group
Active Comparator group
Treatment:
Other: bicycle ergometer training with different intensities
non-exercising group
No Intervention group

Trial contacts and locations

0

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Central trial contact

Stefano Palma, MD

Data sourced from clinicaltrials.gov

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