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Multimodal Intervention in Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427115
First Posted: January 26, 2007
Last Update Posted: May 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention Phase
Allogeneic Stem Cell Transplantation Leukemia Behavioral: Multimodal exercise and psychosocial program Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of an Exercise an Psycho-Educational Intervention During Allogeneic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test [ Time Frame: Baseline, post ]

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

Enrollment: 42
Study Start Date: August 2005
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427115


Locations
Denmark
Copenhagen University Hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
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
  More Information

Responsible Party: University Hospitals Center for Nursing and Care Research, Copenhagen, Denmark, Copenhagen University Hospital
ClinicalTrials.gov Identifier: NCT00427115     History of Changes
Other Study ID Numbers: 01-173/04
First Submitted: January 25, 2007
First Posted: January 26, 2007
Last Update Posted: May 21, 2008
Last Verified: May 2008

Keywords provided by Rigshospitalet, Denmark:
Patients undergoing allogeneic stem cell transplantations