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: June 14, 2012

Last verified: June 2012

History of Changes

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 Behavioral: physiacl exercise vs treatment as usual	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:

MedlinePlus related topics: Cancer Exercise and Physical Fitness Palliative Care

U.S. FDA Resources

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: 1 Physical exercise twice a week for 8 weeks	Behavioral: Physical exercise Physical exercise twice a week for 8 weeks
No Intervention: 2 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
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:

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 Ø, Kaasa S. Physical exercise for cancer patients with advanced disease: a randomized controlled trial. Oncologist. 2011;16(11):1649-57. Epub 2011 Sep 26.

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:	June 14, 2012
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 May 21, 2013

To Top