Prehabilitation in Patients Suffering From Gynecological Cancers

Prehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04618094
• Other study ID #: Prehab
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Prehabilitation
• Stress, Psychological

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