The Physical Exercise and Prostate Cancer Study

NCT ID: NCT00658229

Last Updated: 2012-10-15

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Exercise Prostatic Neoplasm Androgen Deprivation

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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Strength training group

A four months strength training program during androgen deprivation therapy for prostate cancer patietns.

Group Type EXPERIMENTAL

Strength training group

Intervention Type BEHAVIORAL

After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).

Control group

Patients in the control group are not discouraged from performing normal activities. They are however asked not to start a strength training program or increase their activity level in the same period as the experimental group is performing their strength training program. We will offer the control group a modified strength training program after the post-intervention assessment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strength training group

After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).

Intervention Type BEHAVIORAL

Other Intervention Names

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Exercise, Physical activity

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed locally advanced prostate cancer (clinical stage T2 and T3)
* Referred to RH and UUS for radiotherapy
* \< 75 years
* Capable of reading and writing Norwegian
* Treating oncologist must approve of the subjects' participation
* Living within approximately 1 hour from Oslo by car or public transportation

Exclusion Criteria

* Routinely resistance training with manuals
* Medication for osteoporosis (i.e. bisphosphonates)
* Conditions of a severity that contraindicate exercise without adjusted actions
* Mentally incompetent conditions
* Conditions of a severity that complicates the ability to participate in a supervised training program
Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role collaborator

Norwegian School of Sport Sciences

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lene Thorsen

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lene Thorsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Rikshospitalet- Radiumhospitalet HF

Montebello, Oslo County, Norway

Site Status

Countries

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Norway

References

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Thorsen L, Nilsen TS, Raastad T, Courneya KS, Skovlund E, Fossa SD. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design. BMC Cancer. 2012 Mar 29;12:123. doi: 10.1186/1471-2407-12-123.

Reference Type DERIVED
PMID: 22458865 (View on PubMed)

Other Identifiers

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REK - 08/212b

Identifier Type: -

Identifier Source: org_study_id