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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00397774
First received: November 9, 2006
Last updated: March 28, 2015
Last verified: March 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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 ]

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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 9, 2006
Last Updated: March 28, 2015
Health Authority: Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on July 21, 2016