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Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397774
First Posted: November 10, 2006
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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
Cancer Behavioral: Physical exercise Other: best supportive care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Fatigue [ Time Frame: immediately before and after the intervention ]

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

Enrollment: 231
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise
Physical exercise twice a week for 8 weeks, and best supportive care
Behavioral: Physical exercise
Physical exercise twice a week for 8 weeks, and best supportive care
Other: best supportive care
No exercise
Best supportive care, no exercise
Other: best supportive care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397774


Locations
Norway
Sunniva Clinic for Palliative Care
Bergen, Norway
Hospice Lovisenberg
Oslo, Norway
Oslo University Hospital
Oslo, Norway
Telemark Hospital
Skien, Norway
St. Olavs University Hospital
Trondheim, Norway
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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00397774     History of Changes
Other Study ID Numbers: 4.2006.2179
First Submitted: November 9, 2006
First Posted: November 10, 2006
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Norwegian University of Science and Technology:
Palliative care
Physical exercise
Physical function