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

NCT ID: NCT00397774

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise

Physical exercise twice a week for 8 weeks, and best supportive care

Group Type ACTIVE_COMPARATOR

Physical exercise

Intervention Type BEHAVIORAL

Physical exercise twice a week for 8 weeks, and best supportive care

best supportive care

Intervention Type OTHER

No exercise

Best supportive care, no exercise

Group Type OTHER

best supportive care

Intervention Type OTHER

Interventions

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Physical exercise

Physical exercise twice a week for 8 weeks, and best supportive care

Intervention Type BEHAVIORAL

best supportive care

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Line M Oldervoll, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cancer Reserach and Molecular Medicine

Locations

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Sunniva Clinic for Palliative Care

Bergen, , Norway

Site Status

Hospice Lovisenberg

Oslo, , Norway

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Telemark Hospital

Skien, , Norway

Site Status

St. Olavs University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 21948693 (View on PubMed)

Other Identifiers

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4.2006.2179

Identifier Type: -

Identifier Source: org_study_id

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