Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
1 other identifier
interventional
231
1 country
5
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 cancer
Started Oct 2006
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 9, 2006
CompletedFirst Posted
Study publicly available on registry
November 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 31, 2015
March 1, 2015
2.7 years
November 9, 2006
March 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue
immediately before and after the intervention
Secondary Outcomes (1)
Health related quality of life and physical functioning
immediately before and after the intervention
Study Arms (2)
Exercise
ACTIVE COMPARATORPhysical exercise twice a week for 8 weeks, and best supportive care
No exercise
OTHERBest supportive care, no exercise
Interventions
Physical exercise twice a week for 8 weeks, and best supportive care
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (1)
Oldervoll LM, Loge JH, Lydersen S, Paltiel H, Asp MB, Nygaard UV, Oredalen E, Frantzen TL, Lesteberg I, Amundsen L, Hjermstad MJ, Haugen DF, Paulsen O, Kaasa S. Physical exercise for cancer patients with advanced disease: a randomized controlled trial. Oncologist. 2011;16(11):1649-57. doi: 10.1634/theoncologist.2011-0133. Epub 2011 Sep 26.
PMID: 21948693RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Line M Oldervoll, PhD
Department of Cancer Reserach and Molecular Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2006
First Posted
November 10, 2006
Study Start
October 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 31, 2015
Record last verified: 2015-03