Prehabilitation in Patients Suffering From Gynecological Cancers

Feasibility and Acceptance of High Intensity Interval Training in the Prehabilitation of Patients Suffering From Gynecological Cancers - a Randomized Controlled Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Prehabilitation
• Intervention / Treatment: Other: bicycle ergometer training with different intensities

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Palma, MD; Phone Number: 434040023080; Email: stefano.palma@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence to the exercise intervention	rate of completed exercise sessions as a measure of feasibility and acceptance	4 to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular fitness	determined by VO2max	4 to 8 Weeks
workability	determined by the workability index questionnaire; minimum value 7, maximum value 49, higher values indicating better results	4 to 8 weeks
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
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
handgrip strength	determined by the handgrip dynamometer	4 to 8 weeks
body composition	determined by bioimpedance analysis	4 to 8 weeks
Cholesterol	Laboratory parameter in mg/ml as a part of the evaluation for cardiovascular risk factors	4 to 8 weeks
Thyreoglobulin	Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors	4 to 8 weeks
hemoglobin A1c	Laboratory parameter in % as a part of the evaluation for cardiovascular risk factors	4 to 8 weeks
Brain natriuretic peptide	Laboratory parameter in pg/ml as a part of the evaluation for cardiovascular risk factors	4 to 8 weeks
Troponin T	Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors	4 to 8 weeks
Creatin Kinase	Laboratory parameter in U/l as a part of the evaluation for cardiovascular risk factors	4 to 8 weeks
C-reactive protein	Laboratory parameter in mg/l as a part of the evaluation for inflammation	4 to 8 weeks
interleukin 1	Laboratory parameter in ng/ml as a part of the evaluation for inflammation	4 to 8 Weeks
interleukin 6	Laboratory parameter in ng/ml as a part of the evaluation for inflammation	4 to 8 weeks
Tumor Necrosis Factor alpha	Laboratory parameter in pg/ml as a part of the evaluation for inflammation	4 to 8 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Stefano Palma, MD, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Prehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No