Prehabilitation in Patients Suffering From Gynecological Cancers

NCT04618094 | Unknown DMC

• 1 other identifier: Prehab
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• adherence to the exercise intervention

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

  4 to 8 weeks

Secondary Outcomes (16)

• cardiovascular fitness

  4 to 8 Weeks

• workability

  4 to 8 weeks

• Health related Quality of life: questionnaire

  4 to 8 weeks

• Anxiety and depression

  4 to 8 weeks

• handgrip strength

  4 to 8 weeks

Study Arms (3)

High intensity interval group

EXPERIMENTAL

Other: bicycle ergometer training with different intensities

Moderate continous intensity group

ACTIVE COMPARATOR

Other: bicycle ergometer training with different intensities

non-exercising group

NO INTERVENTION

Interventions

bicycle ergometer training with different intensities 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.

High intensity interval group; Moderate continous intensity group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Officials

• Stefano Palma, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Palma, MD

CONTACT

434040023080; stefano.palma@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD student

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 5, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share