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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014