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Multimodal Intervention in Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00427115
First received: January 25, 2007
Last updated: May 20, 2008
Last verified: May 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life indices [ Time Frame: baseline, post, 3 and 6 months ] [ Designated as safety issue: No ]
  • FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form [ Time Frame: baseline, post, 3 and 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 25, 2007
Last Updated: May 20, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013