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Multimodal Intervention in Allogeneic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00427115
Recruitment Status : Completed
First Posted : January 26, 2007
Last Update Posted : May 21, 2008
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Leukemia Behavioral: Multimodal exercise and psychosocial program Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine





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

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

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 Posted: January 26, 2007    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

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