PrehabilitationNCT04618094
Prehabilitation in Patients Suffering From Gynecological Cancers
A study testing bicycle ergometer training with different intensities in people with Prehabilitation, run by Medical University of Vienna.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Prehabilitation
- What is being tested?
- bicycle ergometer training with different intensities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Prehabilitation
- Being tested
- bicycle ergometer training with different intensities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicycle ergometer training with different intensitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval group | Experimental | Not described Receives: Other: bicycle ergometer training with different intensities |
| Moderate continous intensity group | Active comparator | Not described Receives: Other: bicycle ergometer training with different intensities |
| non-exercising group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to the exercise intervention
rate of completed exercise sessions as a measure of feasibility and acceptance
Measured: 4 to 8 weeks
Secondary outcomes (16)
cardiovascular fitness
determined by VO2max
Measured: 4 to 8 Weeks
workability
determined by the workability index questionnaire; minimum value 7, maximum value 49, higher values indicating better results
Measured: 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
Measured: 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
Measured: 4 to 8 weeks
handgrip strength
determined by the handgrip dynamometer
Measured: 4 to 8 weeks
body composition
determined by bioimpedance analysis
Measured: 4 to 8 weeks
Cholesterol
Laboratory parameter in mg/ml as a part of the evaluation for cardiovascular risk factors
Measured: 4 to 8 weeks
Thyreoglobulin
Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors
Measured: 4 to 8 weeks
hemoglobin A1c
Laboratory parameter in % as a part of the evaluation for cardiovascular risk factors
Measured: 4 to 8 weeks
Brain natriuretic peptide
Laboratory parameter in pg/ml as a part of the evaluation for cardiovascular risk factors
Measured: 4 to 8 weeks
Troponin T
Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors
Measured: 4 to 8 weeks
Creatin Kinase
Laboratory parameter in U/l as a part of the evaluation for cardiovascular risk factors
Measured: 4 to 8 weeks
C-reactive protein
Laboratory parameter in mg/l as a part of the evaluation for inflammation
Measured: 4 to 8 weeks
interleukin 1
Laboratory parameter in ng/ml as a part of the evaluation for inflammation
Measured: 4 to 8 Weeks
interleukin 6
Laboratory parameter in ng/ml as a part of the evaluation for inflammation
Measured: 4 to 8 weeks
Tumor Necrosis Factor alpha
Laboratory parameter in pg/ml as a part of the evaluation for inflammation
Measured: 4 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palma, Medical University of Vienna
- Investigators
- Stefano Palma, MD, Principal investigator, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618094
- Sponsor's protocol ID
- Prehab
- Status last verified
- Nov 2020
- First submitted
- 15 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No