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Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
This study is currently recruiting participants.
Verified by Norwegian University of Science and Technology, May 2008
Sponsored by: Norwegian University of Science and Technology
Information provided by: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00397774
  Purpose

The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


Condition Intervention Phase
Palliative Care
Cancer
Physical Exercise
Physical Function
Behavioral: Physical exercise
Behavioral: physiacl exercise vs treatment as usual
Phase III

MedlinePlus related topics: Cancer Exercise and Physical Fitness Palliative Care
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Fatigue [ Time Frame: immediately before and after the intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Health related quality of life and physical functioning [ Time Frame: immediately before and after the intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: October 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Physical exercise twice a week for 8 weeks
Behavioral: Physical exercise
Physical exercise twice a week for 8 weeks
2: No Intervention
Treatment as usual
Behavioral: physiacl exercise vs treatment as usual
treatment as usual

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Palliative cancer patients,
  • life expectancy between 3 and 12 months,
  • Karnofsky status equally or above 60,
  • pain score equal or below 3 on numerical rating scale (0-10),
  • cognitive function intact
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397774

Locations
Norway
Institute for cancer and molecular research Recruiting
Trondheim, Norway, 7006
Contact: Line M Oldervoll, PhD     +4773867264     line.oldervoll@ntnu.no    
Principal Investigator: Line M Oldervoll, PhD            
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Line M Oldervoll, PhD Department of Cancer Reserach and Molecular Medicine
  More Information

Responsible Party: Institute for cancer research and molecular medicine, NTNU ( Line Oldervoll )
Study ID Numbers: 4.2006.2179
Study First Received: November 9, 2006
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00397774  
Health Authority: Norway: Norwegian Social Science Data Services

ClinicalTrials.gov processed this record on January 14, 2009