Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study

NCT ID: NCT01557686

Last Updated: 2012-03-19

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

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.

Detailed Description

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Conditions

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Acute Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Health counseling and exercise

The intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 weeks. The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
* Normal EKG, blood pressure and pulse
* Signed informed written consent

Exclusion Criteria

* Medical reason that contraindicates physical activity
* Patients diagnosed with a symptomatic cardiac disease within the last three months.
* Documented bone metastasis
* Dementia, psychotic
* Cannot write or read Danish
* Patients unable to carry out baseline tests
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Lundbeck Foundation

OTHER

Sponsor Role collaborator

Universitetshospitalernes Center for Sygepleje

OTHER

Sponsor Role lead

Responsible Party

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Mary Jarden

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Jarden, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital at Herlev

Locations

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Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-4-2010-046 Pilot

Identifier Type: -

Identifier Source: org_study_id

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