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Multimodal Intervention in Allogeneic Stem Cell Transplantation

This study has been completed.
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: January 25, 2007
Last updated: May 20, 2008
Last verified: May 2008
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)

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

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
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Please refer to this study by its identifier: NCT00427115

Copenhagen University Hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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 Identifier: NCT00427115     History of Changes
Other Study ID Numbers: 01-173/04
Study First Received: January 25, 2007
Last Updated: May 20, 2008

Keywords provided by Rigshospitalet, Denmark:
Patients undergoing allogeneic stem cell transplantations processed this record on August 23, 2017