Prehabilitation in Patients Suffering From Gynecological Cancers

NCT ID: NCT04618094

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-01-01

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.

Conditions

Prehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

High intensity interval group

Group Type: EXPERIMENTAL

bicycle ergometer training with different intensities

Intervention Type: OTHER

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.

Moderate continous intensity group

Group Type: ACTIVE_COMPARATOR

bicycle ergometer training with different intensities

Intervention Type: OTHER

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.

non-exercising group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Stefano Palma

Principal Investigator, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Palma, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria

Central Contacts

Stefano Palma, MD

Role: CONTACT

Phone: 434040023080

Email: stefano.palma@meduniwien.ac.at

Other Identifiers

Prehab

Identifier Type: -

Identifier Source: org_study_id