CClinicalTrials.gg
Status unknownNCT04618094Updated Nov 5, 2020

Prehabilitation in Patients Suffering From Gynecological Cancers

An interventional study of bicycle ergometer training with different intensities in Prehabilitation, sponsored by Medical University of Vienna. Status unknown. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
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Study 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.

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Conditions studied

  • Prehabilitation
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In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    High intensity interval group

    Other: bicycle ergometer training with different intensities

  • Active comparator
    Moderate continous intensity group

    Other: bicycle ergometer training with different intensities

  • No intervention
    non-exercising group

Interventions

  • Otherbicycle 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.

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What researchers measure

Primary outcomes

  1. adherence to the exercise intervention

    rate of completed exercise sessions as a measure of feasibility and acceptance

    Time frame: 4 to 8 weeks

Secondary outcomes

  1. cardiovascular fitness

    determined by VO2max

    Time frame: 4 to 8 Weeks

  2. workability

    determined by the workability index questionnaire; minimum value 7, maximum value 49, higher values indicating better results

    Time frame: 4 to 8 weeks

  3. Health related Quality of life: questionnaire

    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

    Time frame: 4 to 8 weeks

  4. Anxiety and depression

    determined by the Hospital Anxiety and Depression Scale questionnaire, minimum value 14, maximum value 56, higher values indicating higher depression levels

    Time frame: 4 to 8 weeks

  5. handgrip strength

    determined by the handgrip dynamometer

    Time frame: 4 to 8 weeks

  6. body composition

    determined by bioimpedance analysis

    Time frame: 4 to 8 weeks

  7. Cholesterol

    Laboratory parameter in mg/ml as a part of the evaluation for cardiovascular risk factors

    Time frame: 4 to 8 weeks

  8. Thyreoglobulin

    Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors

    Time frame: 4 to 8 weeks

  9. hemoglobin A1c

    Laboratory parameter in % as a part of the evaluation for cardiovascular risk factors

    Time frame: 4 to 8 weeks

  10. Brain natriuretic peptide

    Laboratory parameter in pg/ml as a part of the evaluation for cardiovascular risk factors

    Time frame: 4 to 8 weeks

  11. Troponin T

    Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors

    Time frame: 4 to 8 weeks

  12. Creatin Kinase

    Laboratory parameter in U/l as a part of the evaluation for cardiovascular risk factors

    Time frame: 4 to 8 weeks

  13. C-reactive protein

    Laboratory parameter in mg/l as a part of the evaluation for inflammation

    Time frame: 4 to 8 weeks

  14. interleukin 1

    Laboratory parameter in ng/ml as a part of the evaluation for inflammation

    Time frame: 4 to 8 Weeks

  15. interleukin 6

    Laboratory parameter in ng/ml as a part of the evaluation for inflammation

    Time frame: 4 to 8 weeks

  16. Tumor Necrosis Factor alpha

    Laboratory parameter in pg/ml as a part of the evaluation for inflammation

    Time frame: 4 to 8 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04618094
Lead sponsor
Medical University of Vienna
Responsible party
Stefano Palma (Principal Investigator, PhD student, Medical University of Vienna) — Principal investigator
First posted
Nov 5, 2020
Start date
Jan 1, 2021 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Nov 5, 2020

Study contacts

Stefano Palma, MD
Contact
stefano.palma@meduniwien.ac.at
434040023080
Stefano Palma, MD
principal investigator · Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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