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Clinical Trials/NCT04328038
NCT04328038
Active, not recruiting
Not Applicable

Personalized Exercise Oncology (PEXO) - Study

University Hospital Heidelberg1 site in 1 country800 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
University Hospital Heidelberg
Enrollment
800
Locations
1
Primary Endpoint
Patient Clusters
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The Goal of the study is to identify trait-homogenous groups of cancer patients in regards to their physical activity associated health literacy. Based on these Groups, individualized exercise protocols and educative strategies can be developed which may increase the efficacy of the exercise therapy and increases the likelihood that patient get involved in physical activity.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
February 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joachim Wiskemann

Head of Exercise Onoclogy, Principal Investigator, Associated Professor

University Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed cancer diagnosis
  • Females and males ≥18 years of age
  • Undergoing either chemo-, immune-, radio- or anti-hormonal treatment
  • Last surgery more than 6 weeks in the past
  • Ability to understand English or German
  • Be able to provide and understand informed consent
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Score of ≤ 2

Exclusion Criteria

  • Heart insufficiency \> NYHA III (New York Heart Association) or uncertain arrhythmia
  • Uncontrolled hypertension
  • Severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl)
  • Reduced standing or walking
  • Current pregnancy
  • Any other evidence in the medical record of an absolute contraindication for exercise

Outcomes

Primary Outcomes

Patient Clusters

Time Frame: through study completion, an average of 1 year

Identification of different, trait-homogenous patient clusters

Secondary Outcomes

  • Questionnaire: Health Literacy(through study completion, an average of 1 year)
  • Questionnaire: Physical Activity Associated Health Literacy(through study completion, an average of 1 year)
  • Questionnaire: Health Related Quality of Life(through study completion, an average of 1 year)
  • Questionnaire: Fatigue(through study completion, an average of 1 year)
  • Questionnaire: Physical Activity(through study completion, an average of 1 year)
  • Questionnaire: Brief Pain Inventory (BPI)(through study completion, an average of 1 year)
  • Questionnaire: Emotion Thermometers(through study completion, an average of 1 year)

Study Sites (1)

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