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Multimodal Intervention in Allogeneic Stem Cell Transplantation

NCT ID: NCT00427115

Last Updated: 2008-05-21

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-04-30

Brief Summary

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Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-HCST). The intervention included structured and supervised exercise, relaxation and psycho-educational components. It was hypothesized that the intervention would minimize loss of physical capacity during hospitalization.

Detailed Description

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Conditions

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Allogeneic Stem Cell Transplantation Leukemia

Keywords

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Patients undergoing allogeneic stem cell transplantations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Multimodal exercise and psychosocial program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-65 yrs
* patients undergoing allogeneic stem cell transplantation

Exclusion Criteria

* recent cardiovascular or pulmonary disease
* abnormal EKG
* psychiatric disorder
* motor function, musculoskeletal or neurological disturbances
* bony metastasis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Copenhagen University Hospital

Principal Investigators

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Mary E Jarden, MSN PhD stud

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Denmark

Lis Adamsen, ProfessorPhD

Role: STUDY_CHAIR

Copehagen University, Faculty of Health Sciences, Denmark

Locations

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Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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01-173/04

Identifier Type: -

Identifier Source: org_study_id