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CompletedNCT00427115Updated May 21, 2008

Multimodal Intervention in Allogeneic Stem Cell Transplantation

A Phase 3 interventional study of Multimodal exercise and psychosocial program in Allogeneic Stem Cell Transplantation and Leukemia, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-05-21.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allogeneic Stem Cell Transplantation
  • Leukemia

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Keywords

  • Patients undergoing allogeneic stem cell transplantations
03

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

This study's enrollment of 42 is above the median of 38 across 4,268 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-65 yrs
  • patients undergoing allogeneic stem cell transplantation

Exclusion criteria

Exclusion Criteria:

  • recent cardiovascular or pulmonary disease
  • abnormal EKG
  • psychiatric disorder
  • motor function, musculoskeletal or neurological disturbances
  • bony metastasis
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Interventions

  • BehavioralMultimodal exercise and psychosocial program
06

What researchers measure

Primary outcomes

  1. Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test

    Time frame: Baseline, post

Secondary outcomes

  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

07

Study locations

1 site
  • Copenhagen University Hospital
    Copenhagen, 2100, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2005, a primary completion of Dec 2007 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2007
First posted
Jan 26, 2007
Start
Aug 2005
Primary completionActual
Dec 2007
CompletionActual
Apr 2008
Last update
May 21, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00427115
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
First posted
Jan 26, 2007
Start date
Aug 2005
Primary completion
Dec 2007
Completion
Apr 2008
Last update
May 21, 2008

Study contacts

Mary E Jarden, MSN PhD stud
principal investigator · Copenhagen University Hospital, Denmark
Lis Adamsen, ProfessorPhD
study chair · Copehagen University, Faculty of Health Sciences, Denmark
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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