Multimodal Intervention in Allogeneic Stem Cell Transplantation

May 20, 2008 updated by: Rigshospitalet, Denmark

Pilot Study of an Exercise an Psycho-Educational Intervention During Allogeneic Stem Cell Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Multimodal exercise and psychosocial program

Study Type

Interventional

Enrollment (Actual)

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

Denmark
- - Copenhagen, Denmark, 2100
    - Copenhagen 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test Time Frame: Baseline, post	Baseline, post

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life indices Time Frame: baseline, post, 3 and 6 months	baseline, post, 3 and 6 months
FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form Time Frame: baseline, post, 3 and 6 months	baseline, post, 3 and 6 months

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

Principal Investigator: Mary E Jarden, MSN PhD stud, Copenhagen University Hospital, Denmark
Study Chair: Lis Adamsen, ProfessorPhD, Copehagen University, Faculty of Health Sciences, Denmark

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

August 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria