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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04618094
Other study ID # Prehab
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2023

Study information

Verified date November 2020
Source Medical University of Vienna
Contact Stefano Palma, MD
Phone 434040023080
Email stefano.palma@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date January 1, 2023
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Primary adherence to the exercise intervention rate of completed exercise sessions as a measure of feasibility and acceptance 4 to 8 weeks
Secondary cardiovascular fitness determined by VO2max 4 to 8 Weeks
Secondary workability determined by the workability index questionnaire; minimum value 7, maximum value 49, higher values indicating better results 4 to 8 weeks
Secondary 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 4 to 8 weeks
Secondary Anxiety and depression determined by the Hospital Anxiety and Depression Scale questionnaire, minimum value 14, maximum value 56, higher values indicating higher depression levels 4 to 8 weeks
Secondary handgrip strength determined by the handgrip dynamometer 4 to 8 weeks
Secondary body composition determined by bioimpedance analysis 4 to 8 weeks
Secondary Cholesterol Laboratory parameter in mg/ml as a part of the evaluation for cardiovascular risk factors 4 to 8 weeks
Secondary Thyreoglobulin Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors 4 to 8 weeks
Secondary hemoglobin A1c Laboratory parameter in % as a part of the evaluation for cardiovascular risk factors 4 to 8 weeks
Secondary Brain natriuretic peptide Laboratory parameter in pg/ml as a part of the evaluation for cardiovascular risk factors 4 to 8 weeks
Secondary Troponin T Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors 4 to 8 weeks
Secondary Creatin Kinase Laboratory parameter in U/l as a part of the evaluation for cardiovascular risk factors 4 to 8 weeks
Secondary C-reactive protein Laboratory parameter in mg/l as a part of the evaluation for inflammation 4 to 8 weeks
Secondary interleukin 1 Laboratory parameter in ng/ml as a part of the evaluation for inflammation 4 to 8 Weeks
Secondary interleukin 6 Laboratory parameter in ng/ml as a part of the evaluation for inflammation 4 to 8 weeks
Secondary Tumor Necrosis Factor alpha Laboratory parameter in pg/ml as a part of the evaluation for inflammation 4 to 8 weeks
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