- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00427115
Multimodal Intervention in Allogeneic Stem Cell Transplantation
May 20, 2008 updated by: Rigshospitalet, Denmark
Pilot Study of an Exercise an Psycho-Educational Intervention During Allogeneic Stem Cell Transplantation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Copenhagen University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test
Time Frame: Baseline, post
|
Baseline, post
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life indices
Time Frame: baseline, post, 3 and 6 months
|
baseline, post, 3 and 6 months
|
FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form
Time Frame: baseline, post, 3 and 6 months
|
baseline, post, 3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
January 25, 2007
First Submitted That Met QC Criteria
January 25, 2007
First Posted (Estimate)
January 26, 2007
Study Record Updates
Last Update Posted (Estimate)
May 21, 2008
Last Update Submitted That Met QC Criteria
May 20, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 01-173/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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