Clinical trial NCT04618094: Prehabilitation in Patients Suffering From Gynecological Cancers
Official title: Feasibility and Acceptance of High Intensity Interval Training in the Prehabilitation of Patients Suffering From Gynecological Cancers - a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prehabilitation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: adherence to the exercise intervention
timeFrame: 4 to 8 weeks
Secondary outcomes:
measure: cardiovascular fitness
timeFrame: 4 to 8 Weeks
measure: workability
timeFrame: 4 to 8 weeks
measure: Health related Quality of life: questionnaire
timeFrame: 4 to 8 weeks
measure: Anxiety and depression
timeFrame: 4 to 8 weeks
measure: handgrip strength
timeFrame: 4 to 8 weeks
measure: body composition
timeFrame: 4 to 8 weeks
measure: Cholesterol
timeFrame: 4 to 8 weeks
measure: Thyreoglobulin
timeFrame: 4 to 8 weeks
measure: hemoglobin A1c
timeFrame: 4 to 8 weeks
measure: Brain natriuretic peptide
timeFrame: 4 to 8 weeks
measure: Troponin T
timeFrame: 4 to 8 weeks
measure: Creatin Kinase
timeFrame: 4 to 8 weeks
measure: C-reactive protein
timeFrame: 4 to 8 weeks
measure: interleukin 1
timeFrame: 4 to 8 Weeks
measure: interleukin 6
timeFrame: 4 to 8 weeks
measure: Tumor Necrosis Factor alpha
timeFrame: 4 to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria
name: Stefano Palma, MD
role: PRINCIPAL_INVESTIGATOR
References: