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

March 28, 2015 updated by: Norwegian University of Science and Technology

Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: No exercise
Best supportive care, no exercise
Other: best supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue
Time Frame: immediately before and after the intervention
immediately before and after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life and physical functioning
Time Frame: immediately before and after the intervention
immediately before and after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Line M Oldervoll, PhD, Department of Cancer Reserach and Molecular Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 28, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4.2006.2179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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